Physical Activity Intervention for Older Family Carers

NCT07653061 | Not Yet Recruiting

• 3 other identifiers: R26019360990360824
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Feasibility Studies; Physical Activity and Wellbeing

Keywords

family caregivers; older adults; physical activity; exercise; physical functioning; feasibility; pilot study; health behavior; positive mental health; cognition; stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Change in Physical Activity

  Baseline and 6 months

• Change in Step Count Measured by Accelerometer

  Baseline and 6 months

• Change in Self-Determined Motivation for Physical Activity

  Baseline and 6 months

• Change in Chronic Stress

  Baseline and 6 months

• Change in Stress-Related Symptoms

  Baseline and 6 months

Other Outcomes (15)

• Change in Bodily Pain

  Baseline, 6 months, and 12 months

• Change in Caregiving Experience

  Baseline, 6 months, and 12 months

• Change in Sleep Duration

  Baseline, 6 months, and 12 months

Study Arms (2)

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.

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.

Behavioral: Health education

Interventions

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.

Caregiver-tailored physical activity intervention

Health education BEHAVIORAL

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

Health education control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University: lead
• Finnish Institute for Health and Welfare: collaborator
• Karolinska Institutet: collaborator
• University of Eastern Finland: collaborator

Study Sites (1)

Tampere University

Tampere, 33520, Finland

Location

MeSH Terms

Conditions

Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Jenni Kulmala, Professor

CONTACT

+358 50 4395422; jenni.kulmala@tuni.fi

Tiia Ngandu, MD, PhD

CONTACT

+358 29 524 7716; tiia.ngandu@thl.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FI (1)