Feasibility StudiesCAREFITNCT07653061
Physical Activity Intervention for Older Family Carers
A study testing Physical activity intervention for older family caregivers and Health education in people with Feasibility Studies and Physical Activity and Wellbeing, run by Tampere University at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies, Physical Activity and Wellbeing
- What is being tested?
- Physical activity intervention for older family caregivers and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jun 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Tampere University
Tampere, 33520
Jenni Kulmala, PhD, Professor, +358 50 4395422, jenni.kulmala@tuni.fi
Tiia Ngandu, MD, PhD, +358 29 524 7716, tiia.ngandu@thl.fi
About this study
Official title: Supporting Physical Activity and Functional Capacity Among Older Family Caregivers (CAREFIT): A Six-month, Randomised Controlled Pilot Trial
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:
Read more
- 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
Read the 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.
- Being tested
- Physical activity intervention for older family caregivers, Health education
- Keywords
- family caregivers, older adults, physical activity, exercise, physical functioning, feasibility, pilot study, health behavior, positive mental health, cognition, stress
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity intervention for older family caregiversBehavioural
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.
Health educationBehavioural
General health advice provided at baseline and referral to a web-based educational programme
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-tailored physical activity intervention | Experimental | 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. Receives: Behavioral: Physical activity intervention for older family caregivers |
| Health education control | Active comparator | 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. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants successfully recruited
Ability to enroll the planned number of participants (n=50) within the recruitment period.
Measured: 3-month recruitment period
Retention rate
Proportion of participants completing the six-month trial, with a target retention rate of ≥70%.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (13)
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.
Measured: 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
Measured: 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.
Measured: Baseline and 6 months
Change in Chronic Stress
Change in hair cortisol concentration (HCC) measured from hair samples.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months
Change in Mobility
Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility.
Measured: Baseline and 6 months
Change in Daily functioning
Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.
Measured: Baseline and 6 months
Change in Balance Confidence
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
Measured: Baseline and 6 months
Falls
Self-reported incidence of falls
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Karolinska Institutet, University of Eastern Finland
- Responsible party
- Principal investigator, Jenni Kulmala, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653061
- Sponsor's protocol ID
- R26019
- Other IDs
- 360990, 360824
- Acronym
- CAREFIT
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared due to privacy considerations
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Physical Activity and Functional Capacity Among Older Family Caregivers (CAREFIT): A Six-month, Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07653061
- Acronym / sponsor ID
- CAREFIT / R26019
- Keywords
- family caregivers, older adults, physical activity, exercise, physical functioning, feasibility, pilot study, health behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Karolinska Institutet, University of Eastern Finland
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caregiver-tailored physical activity intervention | Experimental | Behavioral: Physical activity intervention for older family caregiversParticipants 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. |
| Health education control | Active comparator | Behavioral: Health educationParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity intervention for older family caregiversThe 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. | Behavioural | Caregiver-tailored physical activity intervention |
| Health educationGeneral health advice provided at baseline and referral to a web-based educational programme | Behavioural | Health education control |
Primary outcome
Number of participants successfully recruited
Time frame: 3-month recruitment period
Ability to enroll the planned number of participants (n=50) within the recruitment period.
Retention rate
Time frame: 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
Time frame: 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)
Time frame: 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.
13 secondary outcomes
Change in Physical Activity
Time frame: Baseline and 6 months
Change in Step Count Measured by Accelerometer
Time frame: Baseline and 6 months
Change in Self-Determined Motivation for Physical Activity
Time frame: Baseline and 6 months
Change in Chronic Stress
Time frame: Baseline and 6 months
Change in Stress-Related Symptoms
Time frame: Baseline and 6 months
Change in Positive Mental Health
Time frame: Baseline and 6 months
Change in Depressive Symptoms
Time frame: Baseline and 6 months
Change in Physical functioning
Time frame: Baseline and 6 months
Change in Hand Grip Strength
Time frame: Baseline and 6 months
Change in Mobility
Time frame: Baseline and 6 months
Change in Daily functioning
Time frame: Baseline and 6 months
Change in Balance Confidence
Time frame: Baseline and 6 months
Falls
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to privacy considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention for older family caregivers and Health education in people with Feasibility Studies and Physical Activity and Wellbeing, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenni Kulmala, Professor (+358 50 4395422, jenni.kulmala@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants successfully recruited (time frame: 3-month recruitment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.