Physical Activity Intervention for Older Family Carers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTampere University
About this 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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physical activity intervention for older family caregivers
BehavioralThe 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
BehavioralGeneral health advice provided at baseline and referral to a web-based educational programme
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Caregiver-tailored physical activity interventionExperimental treatment 1 intervention
Group B: Health education controlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants successfully recruited
Ability to enroll the planned number of participants (n=50) within the recruitment period.
Time frame
3-month recruitment period2
Retention rate
Proportion of participants completing the six-month trial, with a target retention rate of ≥70%.
Time frame
From enrollment to the end of intervention at 6 months3
Adherence
Attendance at scheduled intervention sessions (in-person and remote), with an indicative target of ≥40% participation.
Time frame
From enrollment to the end of intervention at 6 months4
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.
Time frame
From enrollment to the end of intervention at 6 monthsSecondary outcomes
1
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.
Time frame
Baseline and 6 months2
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
Time frame
Baseline and 6 months3
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.
Time frame
Baseline and 6 months4
Change in Chronic Stress
Change in hair cortisol concentration (HCC) measured from hair samples.
Time frame
Baseline and 6 monthsOther outcomes
1
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.
Time frame
Baseline, 6 months, and 12 months2
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.
Time frame
Baseline, 6 months, and 12 months3
Change in Sleep Duration
Change in self-reported hours of sleep per night.
Time frame
Baseline, 6 months, and 12 months4
Change in Blood Pressure
Systolic and diastolic blood pressure measured using standardized procedures
Time frame
Baseline, 6 months, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tampere University
Lead sponsor
Finnish Institute for Health and Welfare
Collaborator
Karolinska Institutet
Collaborator
University of Eastern Finland
Collaborator
Source ClinicalTrials.gov
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