Feasibility Studies, Physical Activity and Wellbeing
Conditions
Keywords
family caregivers, older adults, physical activity, exercise, physical functioning, feasibility, pilot study, health behavior, positive mental health, cognition, stress
Brief summary
The goal of this pilot trial is to learn whether a six-month physical activity program tailored for older family caregivers can be successfully delivered and whether participants are willing and able to take part in it. The study will also explore possible effects of the programme on physical activity, physical function, health, and well-being. The main questions it aims to answer are: * Can enough participants be recruited to the study? * Do participants adhere to the study and complete follow-up assessments? * How often do participants take part in the program activities? * How acceptable and useful do participants find the program? * What are the possible effects of the programme on physical activity, health, and wellbeing. Researchers will compare the physical activity program with a control group that receives health information and education about healthy ageing. Participants will: * Complete health, physical functioning, and questionnaire assessments at the beginning of the study, after 6 months, and after 12 months * Wear an activity monitor on their wrist for 7 days and nights at the beginning of the study and after 6 months * Will be randomly assigned to either a six-month physical activity program designed for older family caregivers, or a control group that receives health information and education about healthy ageing. * If assigned to the physical activity program, participants will take part in weekly group-based and remote exercise sessions for 6 months. * Provide feedback about their experiences of the program
Detailed description
Family caregivers provide substantial support to older adults living at home. Many caregivers are themselves older adults and may experience challenges in maintaining their own health and well-being while providing care. Caregiving responsibilities may limit opportunities for physical activity due to time constraints, competing demands, and the need to remain available for the care recipient. Despite the potential benefits of physical activity for maintaining physical function, mental well-being, and overall health, relatively little is known about how to design and deliver physical activity interventions that are feasible and acceptable for older family caregivers. The CAREFIT study is a randomized controlled pilot trial designed to evaluate the feasibility and acceptability of a physical activity intervention tailored for older family caregivers. The study will provide information on recruitment, retention, adherence, and participant acceptability to support the planning of a future larger-scale trial. The study will also explore potential effects of the intervention on physical activity, physical functioning, motivation, stress, well-being, caregiving experience, cognitive function, and other health-related outcomes. Participants are randomly allocated in a 1:1 ratio to either an intervention group or a control group. The intervention group receives a six-month multi-component physical activity programme specifically designed for older family caregivers. The programme combines supervised group-based exercise sessions with remotely delivered sessions to increase accessibility and accommodate caregiving responsibilities. Exercise activities focus on strength, balance, functional exercise, and light-to-moderate intensity aerobic activity and are adapted to participants' functional abilities. Participants also receive individualized goal-setting and motivational support at the beginning of the programme. In addition, the intervention includes brief guided relaxation exercises and education on themes related to healthy ageing, recovery, musculoskeletal health, and well-being. The control group receives health education, including general information on healthy lifestyle behaviors and educational material related to healthy ageing and brain health, but does not participate in the structured physical activity programme during the intervention period. Outcome assessments are conducted at baseline, after the six-month intervention period, and at a twelve-month follow-up. Post-intervention and follow-up assessments are conducted by study personnel who are not involved in delivering the intervention. The primary purpose is to evaluate the feasibility and acceptability of study procedures and intervention delivery, while generating preliminary data to inform the design and implementation of a future definitive randomized controlled trial.
Interventions
BEHAVIORALPhysical activity intervention for older family caregivers
The intervention consists of a six-month physical activity program designed for older family caregivers. The program combines weekly supervised group-based exercise sessions and weekly remotely delivered exercise sessions. Exercise sessions include strength, balance, functional, and light-to-moderate intensity aerobic activities and are adapted to participants' functional abilities. Participants receive individualized goal-setting and motivational support at the beginning of the program. The intervention also includes brief guided relaxation exercises and thematic content related to healthy ageing, recovery, musculoskeletal health, physical activity, and well-being. The program is designed to support regular physical activity while accommodating caregiving responsibilities and potential barriers to participation.
BEHAVIORALHealth education
General health advice provided at baseline and referral to a web-based educational programme
Sponsors
Tampere University
Finnish Institute for Health and Welfare
Karolinska Institutet
University of Eastern Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This study uses a randomized, parallel-group design in which participants are allocated in a 1:1 ratio to either a caregiver-tailored physical activity intervention or a control group that receives health education, including general information on healthy lifestyle behaviors and educational material on healthy ageing and brain health. The intervention is delivered over six months and includes both supervised group-based sessions and remotely delivered sessions to enhance accessibility and accommodate caregiving responsibilities. Participants are not actively informed of group allocation beyond the practical requirements of participation. Outcome assessments at post-intervention and follow-up are conducted by study personnel who are not involved in delivering the intervention. The primary purpose of the study is to assess feasibility and acceptability, including recruitment, retention, and adherence, to inform the design of a future larger-scale trial.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 65 years or older * Spousal family caregiver living in the same household as the care recipient (a formal caregiving agreement is not required) * Participating in moderate- or vigorous-intensity physical activity fewer than two times per week * Able to safely engage in light-to-moderate physical activity based on self-report and health screening conducted by the study nurse, with consultation from the study physician if required * Able to understand study procedures and provide written informed consent
Exclusion criteria
* Diagnosed dementia, substantial cognitive impairment, or other significant neurological disease that would interfere with participation in the study * Inability to provide informed consent or complete study assessments, as determined by study personnel * Medical conditions that may compromise safe participation in physical activity, including but not limited to active malignant disease, severe major depression, symptomatic cardiovascular disease, or coronary or vascular revascularization within the previous 12 months * Severe visual, hearing, speech, or other sensory or communication impairments that would prevent meaningful participation in the intervention, as determined by the study nurse * Concurrent participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants successfully recruited | 3-month recruitment period | Ability to enroll the planned number of participants (n=50) within the recruitment period. |
| Retention rate | From enrollment to the end of intervention at 6 months | Proportion of participants completing the six-month trial, with a target retention rate of ≥70%. |
| Adherence | From enrollment to the end of intervention at 6 months | Attendance at scheduled intervention sessions (in-person and remote), with an indicative target of ≥40% participation. |
| Acceptability using the Theoretical Framework of Acceptability (TFA) | From enrollment to the end of intervention at 6 months | Theoretical Framework of Acceptability (TFA) (Sekhon et al., 2017). The questionnaire includes items representing the seven TFA constructs, each rated on a 1-5 Likert scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity | Baseline and 6 months | Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity. |
| Change in Step Count Measured by Accelerometer | Baseline and 6 months | Change in daily step count measured using the ActiGraph Link GT9X accelerometer worn continuously for seven consecutive days and nights |
| Change in Self-Determined Motivation for Physical Activity | Baseline and 6 months | Change in Behavioral Regulation in Exercise Questionnaire (BREQ2), which consists of 19 items representing five types of motivational regulation. An overall measure of autonomous motivation for exercise is calculated for the Relative Autonomy Index (RAI). The index score ranges from -24 to 20, where higher values represent more autonomous motivation. |
| Change in Chronic Stress | Baseline and 6 months | Change in hair cortisol concentration (HCC) measured from hair samples. |
| Change in Stress-Related Symptoms | Baseline and 6 months | Change in Perceived Stress Scale (PSS-14). Values ranging 0-56, with lower scores indicating a better outcome. |
| Change in Positive Mental Health | Baseline and 6 months | Change in Warwick-Edinburgh Mental Well-being Scale. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing. |
| Change in Depressive Symptoms | Baseline and 6 months | Change in Geriatric Depression Scale (GDS-15). Values ranging 0-15, with lower scores indicating a better outcome. |
| Change in Physical functioning | Baseline and 6 months | Change in Short Physical Performance Battery (SPPB) total score, including balance, chair stand performance, and walking speed tests under single-task and dual-task conditions. Range 0-12, higher scores indicate better physical functioning. |
| Change in Hand Grip Strength | Baseline and 6 months | Change in maximum hand grip strength assessed using a hydraulic hand dynamometer. Higher values indicate greater muscle strength. |
| Change in Mobility | Baseline and 6 months | Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility. |
| Change in Daily functioning | Baseline and 6 months | Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence. |
| Change in Balance Confidence | Baseline and 6 months | Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence. |
| Falls | Baseline to 12 months | Self-reported incidence of falls |
Countries
Finland
Contacts
CONTACTJenni Kulmala, Professor
CONTACTTiia Ngandu, MD, PhD
Outcome results
None listed