Physical Activity Intervention for Older Family Carers (CAREFIT)

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:

• 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

Study Overview

• Status: Not yet recruiting
• Conditions: Feasibility Studies; Physical Activity and Wellbeing
• Intervention / Treatment: Behavioral: Physical activity intervention for older family caregivers; Behavioral: Health education

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenni Kulmala, Professor; Phone Number: +358 50 4395422; Email: jenni.kulmala@tuni.fi
• Study Contact Backup: Name: Tiia Ngandu, MD, PhD; Phone Number: +358 29 524 7716; Email: tiia.ngandu@thl.fi

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Tampere University
    • Contact: Tiia Ngandu, MD, PhD; Phone Number: +358 29 524 7716; Email: tiia.ngandu@thl.fi
    • Contact: Jenni Kulmala, PhD, Professor; Phone Number: +358 50 4395422; Email: jenni.kulmala@tuni.fi
    • Principal Investigator: Jenni Kulmala, PhD, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caregiver-tailored physical activity intervention; 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; 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.
Active Comparator: Health education control; 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; General health advice provided at baseline and referral to a web-based educational programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants successfully recruited	Ability to enroll the planned number of participants (n=50) within the recruitment period.	3-month recruitment period
Retention rate	Proportion of participants completing the six-month trial, with a target retention rate of ≥70%.	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.	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.	From enrollment to the end of intervention at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Baseline and 6 months
Change in Chronic Stress	Change in hair cortisol concentration (HCC) measured from hair samples.	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.	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.	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.	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.	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.	Baseline and 6 months
Change in Mobility	Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility.	Baseline and 6 months
Change in Daily functioning	Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.	Baseline and 6 months
Change in Balance Confidence	Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.	Baseline and 6 months
Falls	Self-reported incidence of falls	Baseline to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 6 months, and 12 months
Change in Sleep Duration	Change in self-reported hours of sleep per night.	Baseline, 6 months, and 12 months
Change in Blood Pressure	Systolic and diastolic blood pressure measured using standardized procedures	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.	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.	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.	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.	12 months
Change in Depressive Symptoms	Change in Geriatric Depression Scale (GDS-15). Values ranging 0-15, with lower scores indicating a better outcome.	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.	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.	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.	12 months
Change in Daily functioning	Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.	12 months
Change in Balance confidence	Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.	12 months
Change in Cognitive performance	Change in Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function.	Baseline, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Karolinska Institutet; University of Eastern Finland; Finnish Institute for Health and Welfare

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; exercise; older adults; cognition; stress; feasibility; pilot study; health behavior; family caregivers; physical functioning; positive mental health
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Health Behavior
• Other Study ID Numbers: R26019; 360990 (Other Grant/Funding Number: Research Council of Finland); 360824 (Other Grant/Funding Number: Research Council of Finland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may not be shared due to privacy considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No