Outcomes of Physical Activity for People Living with Dementia:

Outcomes of Physical Activity for People Living with Dementia: 1 Qualitative Study to Inform a Core Outcome Set 2 Ana-Carolina Gonçalves a,b (A.C.Goncalves@soton.ac.uk); Alda Marques c (amarques@ua.pt); 3 Dinesh Samuel a (D.Samuel@soton.ac.uk); Sara Demain a,* (sara.demain@plymouth.ac.uk). 4 5 a. School of Health Sciences, Faculty of Environmental and Life Sciences, University of 6 Southampton, Southampton, United Kingdom. 7 b. Solent NHS Trust, Southampton, United Kingdom. 8 c. School of Health Sciences (ESSUA) and iBiMED in from of Institute for Biomedicine (iBiMED), 9 University of Aveiro, Aveiro, Portugal. 10 11 *Corresponding Author: 12 Dr Sara Demain 13 Present address: 14 Head of School. School of Health Professionals. Peninsula Allied Health Centre. University of 15 Plymouth. Devon. PL6 8BH. 16 Tel: 00441752588847 17 E-mail:sara.demain@plymouth.ac.uk 18 19 20

not meet the needs of a Core Outcome Set applicable across intervention settings, types of dementia 94 and stages of the condition. Furthermore, these qualitative studies are not centred on intervention 95 outcomes, and therefore many outcomes, relevant to participants, may have been missed during data 96 collection. 97 Views of multiple stakeholders -patients, carers and professionals -may facilitate the selection 98 of meaningful outcomes for this Core Outcome Set, leading to the implementation of tailored 99 interventions, in research and clinical practice, as recommended in dementia research and policy [15]. 100 The present qualitative study aimed to inform the next stage (a consensus study) of a Core Recruitment visits were made to support groups, exercise groups and dementia related activities 116 and events. Posters were made available in public spaces (e.g. libraries, churches, social centres) and 117 flyers distributed via gatekeepers in charities and support groups. The study poster and a short 118 description of this research was made available through websites and newsletters of professional 119 organisations. Participants interested in taking part contacted the research team using the contact details 120 provided on posters and flyers. Information about the study was provided to potential participants 121 (verbally and in a writing via the participant information sheet). A date for interview was only arranged 122 with those who wanted to participate. A phone call was made the day before the interview to offer any 123 further clarifications and confirm the interview date. Formal consent was recorded on the day of the 124

interview. 125
This study benefited from patient and public involvement during recruitment and data analysis. 126 A former carer of a person living with dementia, who also had a role as a leader in a carer support group, 127 assisted the team to identify local dementia services and advised on strategies to approach gatekeepers 128 in those organisations. This strategy had a very positive impact on recruitment for this study. She also 129 contributed to the data analysis, by discussing findings with the authors as analysis progressed. 130 131

Inclusion criteria 132
The following participants were included: 133 • People with a diagnosis of dementia, with capacity to consent to take part in research 134 at the time of data collection and able to communicate verbally in English; 135 • Family members who were currently involved or had previously been involved in the 136 care of a relative living with dementia; 137 • Professionals who have been involved in promoting, designing or supporting physical 138 activity for people with dementia. 139

Exclusion criteria 141
People with dementia were excluded if they had been bedridden since before the diagnosis. 142 Family members were excluded if they were not in contact with the person with dementia since their 143 diagnosis. Professionals were excluded if their professional role in dementia care was undertaken 144 exclusively outside of the United Kingdom. Exclusion criteria were discussed with those who expressed 145 an interest in taking part. 146 147 Sampling 148 Purposive sampling was used, aiming for a maximum variation strategy [17] across stakeholder 149 groups, using the following criteria: 150 • Stage of disease progression, determined by the Mini-Mental State Examination score, 151 completed by the first author (ACG -interviewer) immediately prior to the interview: "Mild to 152 moderate" -17 to 26; "Moderate to severe" -10 to 16 and "Severe" -less than 10 [18]; 153

•
Type of dementia; 154 • Activity setting (i.e. community, care or nursing homes, assisted living; hospital); 155 • Levels of physical activity, determined by the score on the Physical Activity Scale for the 156 Elderly [19], completed immediately before the interview, with input from the carer; Scores range from In-depth semi-structured interviews were conducted and audio-recorded by the first author 166 [ACG], a female clinical doctoral research fellow and physiotherapist with previous experience of 167 conducting qualitative studies and, at the time of data collection, was a senior clinician in an Older 168 Person's Mental Health in-patient service, including a dementia ward. Participants were aware of the 169 professional background of the interviewer. Reflective notes were written after each interview. 170 The interview topic guide was designed to enable participants to discuss outcomes of physical 171 activity and explore the importance of such outcomes. Professionals and carers were interviewed face-172 to-face or remotely (via telephone or video call), according to their preference. People living with 173 dementia were interviewed face-to-face, in a private venue of their choice, and encouraged to have a 174 relative or friend with them at all times. During the interviews with people living with dementia, the 175 following strategies were used, based on previous research [22], and the interviewer's [ACG] 176 experience of communicating with people with living with dementia: asking simple questions, giving 177 time for the person to answer, rephrasing the question with help from the carer, maintaining good eye 178 contact, reading body language for signs of fatigue or distress, offering breaks and choosing the time 179 and venue for the interview according to the person's needs. These strategies also facilitated the capacity 180 assessment. Capacity to consent to research was assessed based on the British Psychological Society 181 guidance [23]. When present, the carer helped the researcher to explain the study to the person with 182 dementia, providing all possible opportunities to make an informed decision. Carers were also 183 encouraged to note any signs of discomfort or distress, which may indicate the need to stop the interview. 184 185

Data analysis 186
To address the aims of this study, two separate types of analysis were completed. Both analysis' 187 steps were completed predominantly by the first author, with regular guidance and in consultation with 188 other authors. semantic codes (close to the participants' own words) were used across the data set, to identify potential 192 outcomes of physical activity. An outcome was defined as "a perceived consequence or impact, positive 193 or negative, for people living with dementia, their carers or health services, whether intended or 194 incidental, arising from undertaking physical activity". Codes with equivalent semantic meanings were 195 merged and grouped into higher level codes (outcome domains). At this stage, a deductive approach 196 was used, and the outcome domains were compared, by two independent researchers [ACG and a 197 researcher independent from this research team], against the outcome domains previously reported in 198 the literature [3]. A merged final list of outcome domains was created and the scope of each outcome 199 domain defined. 200 Aim 2: Outcome domains were thematically organised, by identifying patterns and connections 201 between outcomes that could be described by a higher level theme [24]. Each theme represented a 202 meaningful concept to answer the question: "why is physical activity important to people living with 203 dementia?" The final data analysis was presented back to four participants for member checking [25]. 204 205

Participant Characteristics 207
Interviews were conducted with 29 participants (5 people living with dementia; 14 carers and 208 10 professionals). The average interview duration was 67 minutes, ranging from 35 to 101 minutes. 209 was not possible to gather the views of the person living with dementia, the carer was interviewed 212 instead, aiming to get as close as possible to the views of those at the later stages of dementia. In this 213 study, nine of the carers interviewed, were carers of people living with severe dementia and/or people 214 with dementia who were unable to communicate verbally or provide consent.

Aim 1: Comparing outcome domains generated by this study, against those found in the literature. 217
A final list of 77 outcome domains (60 positive/beneficial) was generated. Figure 1 illustrates 218 the process of defining this list of outcome domains. Of the final 77 outcome domains, 10 (8 219 positive/beneficial) were new outcomes generated by this qualitative study and not reported in the 220 literature; nine (4 positive/beneficial) had been identified previously but were not mentioned by 221 participants in this study. Tables 2a and 2b highlight these outcome domains presented per  The data demonstrated that potential positive health benefits of physical activity for people 248 living with dementia are often influenced by other factors: participants weighed up the benefits against 249 the burden that physical activity may generate for people living with dementia; and the extent to which 250 supporting physical activity was beneficial or detrimental to carers. All stakeholder groups also 251 expressed concerns about the potential for increased physical activity increasing the risk of falls: The negative effects or burden of physical activity were not only related to accidents and 255 injuries but also to a range of emotional and behavioural negative effects, such as becoming agitated or 256 distressed, feeling exhausted or not being able to sleep after the activity. 257 "ACG: You said you stopped the ball game because (…) she was aggressive…" Participant: 258 "It wasn't an aggression as in it didn't cause harm to anyone, but the way she was kicking. It was a bit 259 forceful, with quite a grimaced face so that would demonstrate to me that she wasn't particularly happy 260 about this task." Occupational Therapist (All stages -Hospital). 261 Carers also reported on the burden of supporting activity: increased workload from keeping the 262 person living with dementia active, while managing their own health; and perceived negative emotions 263 associated with the activity, such as responsibility, boredom, guilt and worry. 264 Activity generated benefits such as feeling included, gaining a sense of belonging to groups, 305 teams and being active members of society. It also allowed people with dementia to maintain or assume 306 new roles, giving meaning to a new stage of life. It offered people with dementia the opportunity of 307 being interested in a cause and feeling valued, by gaining interest from others. 308 "That's why I came here [became a volunteer in a gardening centre]. Just to be able to help 309

them (…), because I know what it is like (…) and now I understand how the team gets together and do 310
it. You know what I mean? It is great!" Person living with dementia (Mild to moderate stages -difficult-to-access "dementia world", activity was described as an anchor to the present. It is a way of 316 retrieving positive memories and emotions to the present and "living in the moment". Whilst active, 317 people with dementia aimed to have a fulfilling time, filled with opportunities and new experiences. 318 "Being active" was seen as having a positive, proactive attitude of wanting to be alive and wanting to 319 For those providing formal or informal care, delivering activity that people living with dementia 330 could adhere to was considered part of delivering "good care". It was considered "good" because it was 331 cost-effective and specialised for dementia. Participants also reported that providing activity promotes 332 a positive reputation for institutional settings. 333 "From the perspective of the retirement community, (…) I think they liked the fact that it 334 reflected well on them, that they were doing this, so they (…) had it permanently on their website and 335 things like that." Private company (All stages -Community and residential homes). 336 Providing activity also promoted staff satisfaction and retention. From the perspective of family 337 carers, the provision of physical activity helped them feel that they had chosen the right care for their 338 loved one. 339

344
This qualitative study precedes the consensus phase of developing a Core Outcome Set to be 345 used to evaluate physical activity interventions for people with dementia, and represents an innovative 346 methodological approach in Core Outcome Set development. To our knowledge this is also the first 347 qualitative study exploring outcomes of physical activity across dementia types and stages of disease 348 progression, and first qualitative study being published as a pre-consensus phase of a Core Outcome

Implications for Core Outcome Set methodology 358
A total of 10 outcome domains would have been missed in the consensus phase, had this 359 qualitative study not been undertaken. This is a surprisingly high number of outcome domains, as it is 360 often reported that qualitative studies do not add any outcomes to those already in the literature [27]. 361 In line with other Core Outcome Sets for progressive conditions, it was anticipated that the 362 consensus study would be subdivided according to the different stages of disease progression [28]. 363 However, our findings indicate that outcomes of physical activity overlap greatly across settings and stages of dementia. The initial protocol [28] was therefore changed to a single consensus survey. The 365 potential for qualitative findings to inform the structure and design of a Core Outcome Set had not been 366 previously identified [5], and it should be taken into account by future Core Outcome Set developers. 367

368
Contributions to knowledge about relevant effects of physical activity 369 The new outcomes "carer developing friends and getting support"; "meeting individual needs 370 of patient and family"; "becoming interested and gaining interest from others"; "reframing and 371 revisiting the person with dementia" (Table 2a) indicate the important role that physical activity has in 372 supporting people living with dementia and their carers in both adapting to the diagnosis and as 373 dementia progresses. The use of physical activity to maintain the identity as that of "someone active" 374 despite the diagnosis is explained in this study, supporting findings from previous qualitative work [14]. 375 However, the use of activity to embrace new roles (as shown, by the new outcome domains "reframing 376 the person with dementia" and "carer making friends and getting support") is a new perspective, 377 indicating that physical activity can be used as a tool, not only to maintain, but also to adapt a sense of 378 self-identity, as dementia progresses. The concept of exercise identity was shown to be key in a recent 379 model of exercise participation for people with chronic conditions, highlighting how patients choose to 380 exercise according to their age and gender identity, social and cultural norms [29]. Physical activity can 381 therefore be used by people living with dementia, as in other chronic conditions, to continuously 382 (re)frame their identity, while living with a progressive condition. 383 The remaining new outcomes generated by this study reflect potential physical needs of people, 384 either at later stages of dementia, or of those with multiple comorbidities: "improving posture", 385 "preventing incontinence", "managing lower limb oedema" and "managing pressure ulcers". The fact 386 that these are new outcomes, demonstrates the lack of research into physical activity for people with 387 severe dementia [3] and provides new insights into the potential that physical activity may have across 388 stages of disease and for addressing the multi-morbidity that often accompanies the progression of The present study highlights how physical activity interventions can support families living 391 with dementia from early diagnosis and throughout their dementia journeys; a key message in dementia 392 care guidelines and policies [31]. 393 394

Strengths and Limitations 395
In-depth interviews were a challenging method for patients at later stages of dementia or those with 396 limited verbal communication, leading to a sample with more carers than people living with dementia, 397 and a relatively small sample of people living with dementia. This is a potential limitation because this 398 Core Outcome Set aims to be applicable to physical activity interventions including people with 399 dementia in all stages of the condition, and with no restrictions in terms of communication abilities. 400 Including a higher proportion of carers was a successful strategy to gather the views of those closest to 401 people living with late stage dementia. The present study also informs the next stage of the development 402 of this Core Outcome Set (a consensus study), where a larger sample of people living with dementia 403 will be recruited. 404 The identification of outcomes from the interviews was conducted by one researcher only. To 405 minimise this potential limitation, the analysis benefited from patient and public involvement through 406 regular reflections with a former carer of someone living with dementia as the data analysis progressed; 407 the final analysis findings were also 'member checked' by four participants [25]. The process of 408 merging the list of outcomes from this qualitative study with the outcomes in the literature was 409 conducted independently by two researchers, increasing the rigor of this stage of data analysis. This qualitative study makes an important contribution to Core Outcome Set methodology. 413 By adding 10 outcome domains to the list previously generated from published literature it has 414 demonstrated the important role qualitative methods can play in ensuring outcomes meaningful to patients, carers and professionals are not missed. This study also highlights the value of physical activity 416 across the stages of dementia progression. Whilst confirming findings from previous studies that 417 physical activity can contribute to "Being well and staying well" and "Delivering good quality care" it 418 has also identified an important new finding that physical activity is important in the process of adapting 419 to the diagnosis through "Maintaining identity", "Having a role towards and with others" and "Being 420 connected to the present".       Improving posture Includes sitting and standing posture.

Managing lower limb oedema
Fluid retention in the lower limbs.

Managing pressure ulcers
Preventing pressure ulcers and recovering skin integrity. x

Preventing incontinence
Regularly using the toilet, by mobilising to the toilet or commode instead of using a pad.

Carer developing friendships and peer support
Family carers meeting other relatives of people living with dementia and developing a network of friendship and peer support.

Meeting individual needs of patient and family
Meeting individual needs of the person living with dementia. These includes identity, physical, spiritual, emotional and social needs. Meeting tailored needs of families. x

Becoming interested and gaining interest of others
Gaining the interest of the person living with dementia and the interest of staff, formal carers and relatives. Getting relatives and formal carers to know the person with dementia and becoming interested in what they can do.

Reframing and revisiting the person with dementia
Recovering one's "old self" even if for brief moments. Relatives having moments of seeing the "old" person with dementia by seeing them active as they were before the diagnosis. Relatives and staff or formal carers being surprised by the ability of the person living with dementia. Using activity to highlight what the person with dementia can still do.

Eating or drinking
Eating or drinking something that should not be ingested, by confusing it with real food or drink.

Not being able to sleep after an activity
This was linked to possible changes of environment or routine caused by the activity (e.g. coming back to care after having been on holiday).

520
"prof. and researchers" -professionals and researchers; "patients and carers" -people living with dementia and their informal carers or relatives. Boxes identified with "x" indicate that the 521 outcome domain has been identified in that context. Boxes identified with "-" indicate that an outcome domain has not been identified in that particular context. 522 523 524

Carer mobility
Carer mobility and balance, ability to walk with less joint pain.

Carer mood
Simply described as "carer mood".

Carer quality of life
Carer wellbeing and quality of life. At times linked to carer burden.

Carer sleep
Improved carer sleep quality.

Being admitted to hospital or experiencing a deterioration in health
Being hospitalized or admitted to an emergency department. Experiencing a deterioration of overall health or becoming too unwell to continue activity.

Feeling dizzy, nauseous or fainting
Feeling dizzy, nauseous or light-headed. Having a syncopal episode.
x -x x x x --

Increasing mortality
Number of deaths during activity or within the time period while the person with dementia was a participant in an activity intervention.

Moving into care
Being placed into an institution for permanent full-time care.
x -x x x x -- Maximizing abilities using multiple body movements, being able to complete transfers, avoiding being bedridden, being independent in basic and instrumental activities of daily living, including handling cutlery and maintaining coordination to feed oneself. Feeling independent.

"prof. and researchers" -professionals and researchers; "patients and carers" -people living with dementia and their informal carers or relatives. Boxes identified with "-" indicate that an
x

Attenuating disease progression
Maintaining abilities for as long as possible. Preventing decline and delaying onset of health complications. Includes physical and cognitive decline as well as perceived/expected decline in wellbeing Avoiding being admitted to hospital or being discharged quicker Avoiding hospital admissions and reducing length of stay following a hospital admission, reducing social and health care use.

Being more sociable and talkative
Initiating and keeping conversations, sharing stories and having something to talk about.

Enjoying activity and getting a sense of success and pleasure out of it
Having a sense of satisfaction, achievement, completion, success and reward or getting pleasure and joy as a result of activity. Finding activity appealing and feeling good about doing it.

Feeling more relaxed, settled and peaceful
Feeling calmer. Getting a sense of peace and relaxation. Being released from anxiety or confusion and feeling better in oneself post activity. Absence of physical and mental stress.

Having a healthy routine and a balanced life
Having a sense of order in the day, Keeping the momentum, getting the recommended hours of sleep and having good sleep hygiene and sleep patter. Having a healthy number of meals per day. Having a balance of

Improving ability to complete movements and tasks without difficulty
Incorporates fine motor skills, dexterity, hand-eye coordination, praxis and use of quick-reactions. The literature also refers to reaction time, agility, motor skills and ability to conduct movements rightly.

Improving cardiorespiratory and cardiovascular health
Maintaining a healthy weight, maintaining or improving endurance, circulation and lung function. The literature also included the following components: heart rate, blood pressure, maximum oxygen consumption, breath holding duration, oxygen saturation, respiratory exchange rate, respiratory rate and vital capacity.

Improving depressive symptoms and preventing depression
Feeling less depressed. Impacting on how the person sees her/himself; wanting to get out of bed in the morning and gaining motivation to do things. x

Improving dietary intake
Being hungry or having good appetite; eating and drinking more than usual; eating well; eating normally as opposed to not eating enough. x

Improving mood and affective function
Mood levels; lifting mood or being in better mood; being content, brighter, happier or having fun. Having a positive attitude. Showing less negative emotions.

Improving or maintaining balance
Balancing oneself while moving and shifting weight. Challenging balance. Linked to falls risk.

Improving or maintaining mobility
Keeping mobile or regaining mobility; keeping moving; being more mobile indoors and outdoors; standing up and walking up and down. Climbing stairs. Includes all aspects of gait, using less supportive walking aids and keeping the ability to change position.
Improving or maintaining structure and function of the brain Improving, cognition, concentration, alertness, attention, memory and reducing confusion. Seeing changes in brain volumes and physiology of the brain. Being able to calculate, read and recognize places. Keeping the brain active. The literature includes additional specific aspects of cognition, such as: executive function, processing speed, different types of memory, Perception and visual-spatial awareness, body awareness, agnosia, reasoning and ability to follow instructions. Fluid biomarkers are also included in the literature. x

Improving posture
Includes sitting and standing posture.

Improving quality of life and wellbeing
Health related quality of life, in opposition to living longer with poor quality. Also referred to as "raising standards of living". Includes physical, mental, emotional and social wellbeing. Generally feeling better, comfortable (physically and emotionally), improving stamina and managing fatigue. Feeling joy and satisfaction about being alive. x

Increasing levels of physical activity
Amount of physical activity performed by the person with dementia within a defined period of time. Includes measures of time, distance, repetitions and intensity (e.g. weights). The literature also includes the levels of restricted activity (e.g. number of days with no activity).

Keeping healthy, fit and active
Overall health, general ability or performance. Being fit, strong and ready for activity. Staying well and having less medical diagnosis. x

Living longer
Reducing mortality, preventing deaths, lasting longer. x

Maintaining current care arrangements
Living at home for as long as possible and avoid institutionalization. Avoiding increasing need for higher level of care within the same setting. x

Maintaining functional range of movement
Maintaining joint health and flexibility from upper and lower limbs. Avoiding contractures and maintaining movement quality. Maintaining or increasing amplitude of movement. Includes achieving the necessary range of movement to complete functional talks (e.g. putting a coat on). x

Managing behaviours
Overcoming challenging behaviours or behavioural issues, including agitation and aggression, apathy, passivity or lack of eye contact, distress, shouting behaviours, restlessness, pacing, wandering, and feeling angry and frustrated. Using inappropriate language or handling objects inappropriately and "sun downing". Reducing need for restraint.

Managing lower limb oedema
Fluid retention in the lower limbs.

Managing pain
Lower limb pain; arthritic and muscular pain; pain due to constipation.

Managing pressure ulcers
Preventing pressure ulcers and recovering skin integrity.
Opening bowels Regular bowel movements. Linked to a reduction in the use of laxative medication. x

Preventing boredom
Relieving and preventing boredom by changing scenery, experiencing sensory or cognitive stimulation. Avoiding excessive sleep due to lack of interest or stimulation. x

Preventing incontinence
Regularly using the toilet, by mobilizing to the toilet or commode instead of using a pad.

Reducing anxiety
Distracting from a state of anxiety and reducing levels of anxiety.

Reducing use of medication
Taking a reduced number of different drugs and and/or the overall amount of medication. This includes medication for physical and mental health purposes and was linked to a reduction in health related costs. x

Carer developing friendships and peer support
Family carers meeting other relatives of people living with dementia and developing a network of friendship and peer support.

Carer mobility
Carer mobility and balance, ability to walk with less joint pain. x

Carer mood
Simply described as "carer mood".

Carer quality of life
Carer wellbeing and quality of life. At times linked to carer burden. x

Carer regaining sense of satisfaction and achievement
Carers feeling positive about the person with dementia being active, improving and having a fulfilling time. In the literature this was linked to confidence in their care abilities and carers' satisfaction with the intervention. x

Carer sleep
Improved carer sleep quality.

Decreasing carer burden or distress
Activity may reduce the burden of care in the long term by maintaining functional independence of the person with dementia, accessing support from professionals and experiencing less challenging behaviour; In the short term by giving the carer a break while the person with dementia is involved in activity and needing less input from the carer. x

Improving carer general health
Includes weight management, and overall wellbeing and health. In the literature this was measured as the carer's use of health and social care services and therefore linked to costs. x

Increasing carer levels of physical activity
Joining in with the person with dementia, adding to their habitual levels of activity. Carers may face an increase in workload: being/feeling responsible to offer activity and sometimes persuade them to join in activities. For carers, activity can imply effort, fatigue and negative emotions of guilt, frustration and worry about the patient safety. It may increase risks of negative health outcomes to the carer.

Reducing carer depression
Lack of activity and engagement for the person with dementia was linked to carer depression.
x x x x -x --

Subtheme: negative effects or risks of physical activity
Becoming aggressive, agitated, more confused, anxious, depressed or distressed during activity Becoming challenging, frustrated, rude or overstimulated during the activity. In some cases, activities with these effects were considered not appropriate for the person with dementia and are often interrupted. Refusing to go back into a care setting after an activity in a different environment. x Becoming short of breath during activity Shortness of breath, or needing to "catch one's breath" and interrupting the activity because of it. x

Being admitted to hospital or experiencing a deterioration in health
Being hospitalized or admitted to an emergency department. Experiencing a deterioration of overall health or becoming too unwell to continue activity.
x -x x x x x -Being in pain or experiencing discomfort during or after the activity Includes muscle soreness or stiffness after exercising. Complaining of pain or experiencing physical discomfort during activity. Not being able to be as active as usual in the day(s) after the activity.

Eating or drinking something harmful
Eating or drinking something that should not be ingested, by confusing it with real food or drink.

Feeling dizzy, nauseous or fainting
Feeling dizzy, nauseous or light-headed. Having a syncopal episode.
x -x x x x --

Feeling tired or exhausted
Feeling tired, drained, exhausted. Described as something that would stop the activity and that should be used to monitor the intensity of the activity. x

Getting lost
Not being able to find the way back after an activity. Having to use technology to find the person with dementia.

Having a negative experience
Triggering negative emotions or feelings (e.g. embarrassment or unhappiness). Having an unsatisfying experience. Activity reinforcing illness and loss of roles (e.g. Letting the team down) and therefore having a negative impact on perceptions of wellbeing. x

Increasing cardiovascular risk
Suffering a Transient Ischemic Attack or developing cardiac pathology. This was also a reason for caution when involving a person with dementia in activity.

Increasing falls, falls risk, fall related injuries, near falls and fear of falling
Sustaining falls or increasing falls risk by being active. Sustaining injuries after a fall (e.g. fractures) and having to attend emergency care because of falls. Being about to fall, but being able to save oneself. Increasing fear of falling and reducing confidence in walking due to fear of a fall. x

Increasing mortality
Number of deaths during activity or within the time period while the person with dementia was a participant in an activity intervention. x

Moving into care
Being placed into an institution for permanent full-time care.
x -x x x x --

Not being able to sleep after an activity
This was linked to possible changes of environment or routine caused by the activity (e.g. coming back to care after having been on holiday).

Sustaining injuries (not fall related) or hurting others during activity.
Includes injuries to muscles and joints. May result from doing the wrong exercise or overdoing it; or from "bumping into" objects or fellow participants.
x -x x x x x x THEME: Maintaining identity

Feeling free and in control of one's life
Doing something independent from the carer, having rights, choices and interests and doing what one wants to do. Being in control of one's own life and feeling free to ask for activity.

Improving selfesteem, self-worth and self-respect
Sense of self, feeling good about (still) being active and strong and (still) being good at a certain activity. Feeling listened to, valued and respected. x

Making the best of ones' physical abilities
Using one's physical being. Using all available skills and abilities. Expressing a physical self. Seeking movement as a routine part of life. x

Meeting individual needs of patient and family
Meeting individual needs of the person living with dementia. These includes identity, physical, spiritual, emotional and social needs. Meeting tailored needs of families. Being able to connect with the person rather than focusing on the disease through activity. Activity as a constant reminder that the person with dementia is a person and not a diagnosis. x Wanting life to be as normal as possible and continue doing what they have always done.
Feeling normal by keeping moving and keeping activities that are part of a routine, define identity and outline what "normal life" looks like for an individual. Keeping going despite the diagnosis.
x x x x x x x x

Becoming interested and gaining interest of others
Gaining the interest of the person living with dementia and the interest of staff, formal carers and relatives. Getting relatives and formal carers to know the person with dementia and becoming interested in what they can do. x

Experiencing relationships
Doing activities together with staff or relatives and rebuilding relationships. Seeking interaction with others; fighting isolation and loneliness. x

Living in the moment
Being anchored to the present by activity. Learning or doing something new. Having an adventure. Not having to think about anything else. x

Living a fulfilled life rather than just existing
Dementia is not the end. Not be willing to "just sit around waiting to die". Being lively, or coming back to life when active. Staying engaged with life, enjoying every small aspect of life and having a fulfilling time while having dementia. x

Reframing and revisiting the person with dementia
Recovering one's "old self" even if for brief moments. Relatives having moments of seeing the "old" person with dementia by seeing them active as they were before the diagnosis. Relatives and staff or formal carers being surprised by the ability of the person living with dementia. Using activity to highlight what the person with dementia can still do.
x x x x x x x -THEME: Delivering good quality care

Adhering to activity
The extent to which an activity is completed according to a pre-set criteria of duration, frequency and intensity. x

Improving care delivery
For families, good care meant care that offers opportunities for activities that reflect the needs of the person with dementia. For organizations, offering activity for people with dementia meant staff retention and staff satisfaction. An association is made between providing activity and offering good quality of care, that is cost effective in relation to health and social care for patients and carers. It includes defining the longevity of any positive effects of activity.
x x x x x x x x "prof. and researchers" -professionals and researchers; "patients and carers" -people living with dementia and their informal carers or relatives. Boxes identified with "x" indicate that the outcome domain has been identified in that context. Boxes identified with "-" indicate that an outcome domain has not been identified in that particular context. New outcome domains generated by this qualitative study are highlighted; outcomes measured or referred to in previous literature, but not mentioned in this qualitative study are underlined.