An interventional study of Physical activity intervention for older family caregivers and Health education in Feasibility Studies and Physical Activity and Wellbeing, sponsored by Tampere University. Not yet recruiting at 1 site in Finland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Tampere University · Not applicable, Interventional, and Other
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:
Researchers will compare the physical activity program with a control group that receives health information and education about healthy ageing.
Participants will:
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Tampere University is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive a six-month physical activity intervention designed for older family caregivers. The intervention includes weekly supervised group-based exercise sessions and weekly remotely delivered exercise sessions. The exercise program focuses on strength, balance, and light-to-moderate intensity aerobic activity and is adapted to participants' functional abilities. Participants will also receive individualized goal-setting and motivational support, as well as thematic content related to health, recovery, and well-being.
Behavioral: Physical activity intervention for older family caregivers
Participants in the control group receive general health advice during the baseline visit. This advice is delivered verbally by study staff and focuses on lifestyle factors relevant to healthy aging. In addition, control group participants are referred to a FINGER-ABC web-based education program, which provides evidence-based guidance on how to support brain health through lifestyle choices.
Behavioral: Health education
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.
General health advice provided at baseline and referral to a web-based educational programme
Number of participants successfully recruited
Ability to enroll the planned number of participants (n=50) within the recruitment period.
Time frame: 3-month recruitment period
Retention rate
Proportion of participants completing the six-month trial, with a target retention rate of ≥70%.
Time frame: From enrollment to the end of intervention at 6 months
Adherence
Attendance at scheduled intervention sessions (in-person and remote), with an indicative target of ≥40% participation.
Time frame: From enrollment to the end of intervention at 6 months
Acceptability using the Theoretical Framework of Acceptability (TFA)
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.
Time frame: From enrollment to the end of intervention at 6 months
Change in Physical Activity
Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity.
Time frame: Baseline and 6 months
Change in Step Count Measured by Accelerometer
Change in daily step count measured using the ActiGraph Link GT9X accelerometer worn continuously for seven consecutive days and nights
Time frame: Baseline and 6 months
Change in Self-Determined Motivation for Physical Activity
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.
Time frame: Baseline and 6 months
Change in Chronic Stress
Change in hair cortisol concentration (HCC) measured from hair samples.
Time frame: Baseline and 6 months
Change in Stress-Related Symptoms
Change in Perceived Stress Scale (PSS-14). Values ranging 0-56, with lower scores indicating a better outcome.
Time frame: Baseline and 6 months
Change in Positive Mental Health
Change in Warwick-Edinburgh Mental Well-being Scale. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Time frame: Baseline and 6 months
Change in Depressive Symptoms
Change in Geriatric Depression Scale (GDS-15). Values ranging 0-15, with lower scores indicating a better outcome.
Time frame: Baseline and 6 months
Change in Physical functioning
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.
Time frame: Baseline and 6 months
Change in Hand Grip Strength
Change in maximum hand grip strength assessed using a hydraulic hand dynamometer. Higher values indicate greater muscle strength.
Time frame: Baseline and 6 months
Change in Mobility
Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility.
Time frame: Baseline and 6 months
Change in Daily functioning
Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.
Time frame: Baseline and 6 months
Change in Balance Confidence
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
Time frame: Baseline and 6 months
Falls
Self-reported incidence of falls
Time frame: Baseline to 12 months
Change in Bodily Pain
Change in bodily pain subscale of the RAND-36 Health Survey. Pain intensity during the past 4 weeks, rated on a 6-point scale ranging from no pain to very severe pain.
Time frame: Baseline, 6 months, and 12 months
Change in Caregiving Experience
Change in Carers of Older People in Europe Index (COPE). A 15-item questionnaire in which each item is scored on a 1-4 scale.
Time frame: Baseline, 6 months, and 12 months
Change in Sleep Duration
Change in self-reported hours of sleep per night.
Time frame: Baseline, 6 months, and 12 months
Change in Blood Pressure
Systolic and diastolic blood pressure measured using standardized procedures
Time frame: Baseline, 6 months, and 12 months
Change in Physical activity
Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity.
Time frame: 12 months
Change in Self-Determined Motivation for Physical Activity
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.
Time frame: 12 months
Change in Stress-Related Symptoms
Change in Perceived Stress Scale (PSS-14). Values ranging 0-40, with lower scores indicating a better outcome.
Time frame: 12 months
Change in Positive Mental Health
Change in Warwick-Edinburgh Mental Well-being Scale. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Time frame: 12 months
Change in Depressive Symptoms
Change in Geriatric Depression Scale (GDS-15). Values ranging 0-15, with lower scores indicating a better outcome.
Time frame: 12 months
Change in Physical functioning
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.
Time frame: 12 months
Change in Hand Grip Strength
Change in maximum hand grip strength assessed using a hydraulic hand dynamometer. Higher values indicate greater muscle strength.
Time frame: 12 months
Change in Timed Up and Go (TUG) test under single-task and dual-task conditions.
Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility.
Time frame: 12 months
Change in Daily functioning
Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.
Time frame: 12 months
Change in Balance confidence
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
Time frame: 12 months
Change in Cognitive performance
Change in Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function.
Time frame: Baseline, 6 months, and 12 months
Plan to share: Undecided — IPD may not be shared due to privacy considerations
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Aug 2027, 14 months later.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 14 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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