Physical Activity Intervention for Older Family Carers (NCT07653061) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Physical Activity Intervention for Older Family Carers
Finland50 participantsStarted 2026-06-15
Plain-language 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
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants successfully recruited
Timeframe: 3-month recruitment period
2
Retention rate
Timeframe: From enrollment to the end of intervention at 6 months
3
Adherence
Timeframe: From enrollment to the end of intervention at 6 months
4
Acceptability using the Theoretical Framework of Acceptability (TFA)
Timeframe: From enrollment to the end of intervention at 6 months