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NCT Number: NCT07653061

Physical Activity Intervention for Older Family Carers

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

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Key information

Conditions

Feasibility Studies Behavior Health Behavior Motor Activity Physical Activity and Wellbeing

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity intervention for older family caregivers

Behavioral

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 Education

Behavioral

General health advice provided at baseline and referral to a web-based educational programme

Primary outcomes

  1. 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.

  2. 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%.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in Physical Activity

    Time frame: 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.

  2. Change in Step Count Measured by Accelerometer

    Time frame: Baseline and 6 months

    Change in daily step count measured using the ActiGraph Link GT9X accelerometer worn continuously for seven consecutive days and nights

  3. Change in Self-Determined Motivation for Physical Activity

    Time frame: 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.

  4. Change in Chronic Stress

    Time frame: Baseline and 6 months

    Change in hair cortisol concentration (HCC) measured from hair samples.

  5. Change in Stress-Related Symptoms

    Time frame: Baseline and 6 months

    Change in Perceived Stress Scale (PSS-14). Values ranging 0-56, with lower scores indicating a better outcome.

  6. Change in Positive Mental Health

    Time frame: 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.

  7. Change in Depressive Symptoms

    Time frame: Baseline and 6 months

    Change in Geriatric Depression Scale (GDS-15). Values ranging 0-15, with lower scores indicating a better outcome.

  8. Change in Physical functioning

    Time frame: 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.

  9. Change in Hand Grip Strength

    Time frame: Baseline and 6 months

    Change in maximum hand grip strength assessed using a hydraulic hand dynamometer. Higher values indicate greater muscle strength.

  10. Change in Mobility

    Time frame: Baseline and 6 months

    Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility.

  11. Change in Daily functioning

    Time frame: Baseline and 6 months

    Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.

  12. Change in Balance Confidence

    Time frame: Baseline and 6 months

    Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.

  13. Falls

    Time frame: Baseline to 12 months

    Self-reported incidence of falls

Other outcomes

  1. Change in Bodily Pain

    Time frame: Baseline, 6 months, and 12 months

    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.

  2. Change in Caregiving Experience

    Time frame: Baseline, 6 months, and 12 months

    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.

  3. Change in Sleep Duration

    Time frame: Baseline, 6 months, and 12 months

    Change in self-reported hours of sleep per night.

  4. Change in Blood Pressure

    Time frame: Baseline, 6 months, and 12 months

    Systolic and diastolic blood pressure measured using standardized procedures

  5. Change in Physical activity

    Time frame: 12 months

    Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity.

  6. Change in Self-Determined Motivation for Physical Activity

    Time frame: 12 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.

  7. Change in Stress-Related Symptoms

    Time frame: 12 months

    Change in Perceived Stress Scale (PSS-14). Values ranging 0-40, with lower scores indicating a better outcome.

  8. Change in Positive Mental Health

    Time frame: 12 months

    Change in Warwick-Edinburgh Mental Well-being Scale. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.

  9. Change in Depressive Symptoms

    Time frame: 12 months

    Change in Geriatric Depression Scale (GDS-15). Values ranging 0-15, with lower scores indicating a better outcome.

  10. Change in Physical functioning

    Time frame: 12 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.

  11. Change in Hand Grip Strength

    Time frame: 12 months

    Change in maximum hand grip strength assessed using a hydraulic hand dynamometer. Higher values indicate greater muscle strength.

  12. Change in Timed Up and Go (TUG) test under single-task and dual-task conditions.

    Time frame: 12 months

    Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility.

  13. Change in Daily functioning

    Time frame: 12 months

    Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.

  14. Change in Balance confidence

    Time frame: 12 months

    Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.

  15. Change in Cognitive performance

    Time frame: Baseline, 6 months, and 12 months

    Change in Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenni Kulmala, Professor

CONTACT

[email protected]

+358 50 4395422

Tiia Ngandu, MD, PhD

CONTACT

[email protected]

+358 29 524 7716

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Finnish Institute for Health and Welfare
  • Karolinska Institutet
  • University of Eastern Finland

Registry information

Official study title

Supporting Physical Activity and Functional Capacity Among Older Family Caregivers (CAREFIT): A Six-month, Randomised Controlled Pilot Trial

Acronym: CAREFIT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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