Physical Activity Intervention for Older Family Carers

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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 int
• Поведенческое Health education
  General health advice provided at baseline and referral to a web-based educational programme

Первичные конечные точки

• Number of participants successfully recruited [Срок оценки: 3-month recruitment period]
• Retention rate [Срок оценки: From enrollment to the end of intervention at 6 months]
• Adherence [Срок оценки: From enrollment to the end of intervention at 6 months]
• Acceptability using the Theoretical Framework of Acceptability (TFA) [Срок оценки: From enrollment to the end of intervention at 6 months]

Вторичные конечные точки (12)

• Change in Physical Activity [Срок оценки: Baseline and 6 months]
• Change in Step Count Measured by Accelerometer [Срок оценки: Baseline and 6 months]
• Change in Self-Determined Motivation for Physical Activity [Срок оценки: Baseline and 6 months]
• Change in Chronic Stress [Срок оценки: Baseline and 6 months]
• Change in Stress-Related Symptoms [Срок оценки: Baseline and 6 months]
• Change in Positive Mental Health [Срок оценки: Baseline and 6 months]
• Change in Depressive Symptoms [Срок оценки: Baseline and 6 months]
• Change in Physical functioning [Срок оценки: Baseline and 6 months]
• Change in Hand Grip Strength [Срок оценки: Baseline and 6 months]
• Change in Mobility [Срок оценки: Baseline and 6 months]
• Change in Daily functioning [Срок оценки: Baseline and 6 months]
• Change in Balance Confidence [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Финляндия · 1 центр

• Tampere University — Tampere

Идентификаторы

NCT: NCT07653061 · R26019 · 360990 · 360824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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