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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jenni Kulmala, Professor
- 電話番号：+358 50 4395422
- メール：jenni.kulmala@tuni.fi
研究連絡先のバックアップ
- 名前：Tiia Ngandu, MD, PhD
- 電話番号：+358 29 524 7716
- メール：tiia.ngandu@thl.fi
研究場所
-
-
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Tampere、フィンランド、33520
- Tampere University
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コンタクト：
- Tiia Ngandu, MD, PhD
- 電話番号：+358 29 524 7716
- メール：tiia.ngandu@thl.fi
-
コンタクト：
- Jenni Kulmala, PhD, Professor
- 電話番号：+358 50 4395422
- メール：jenni.kulmala@tuni.fi
-
主任研究者：
- Jenni Kulmala, PhD, Professor
-
-
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
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General health advice provided at baseline and referral to a web-based educational programme
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants successfully recruited
時間枠：3-month recruitment period
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Ability to enroll the planned number of participants (n=50) within the recruitment period.
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3-month recruitment period
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Retention rate
時間枠：From enrollment to the end of intervention at 6 months
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Proportion of participants completing the six-month trial, with a target retention rate of ≥70%.
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From enrollment to the end of intervention at 6 months
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Adherence
時間枠：From enrollment to the end of intervention at 6 months
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Attendance at scheduled intervention sessions (in-person and remote), with an indicative target of ≥40% participation.
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From enrollment to the end of intervention at 6 months
|
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Acceptability using the Theoretical Framework of Acceptability (TFA)
時間枠：From enrollment to the end of intervention at 6 months
|
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.
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From enrollment to the end of intervention at 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Physical Activity
時間枠：Baseline and 6 months
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Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ).
Higher scores indicate higher levels of physical activity.
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Baseline and 6 months
|
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Change in Step Count Measured by Accelerometer
時間枠：Baseline and 6 months
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Change in daily step count measured using the ActiGraph Link GT9X accelerometer worn continuously for seven consecutive days and nights
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Baseline and 6 months
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Change in Self-Determined Motivation for Physical Activity
時間枠：Baseline and 6 months
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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.
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Baseline and 6 months
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Change in Chronic Stress
時間枠：Baseline and 6 months
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Change in hair cortisol concentration (HCC) measured from hair samples.
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Baseline and 6 months
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Change in Stress-Related Symptoms
時間枠：Baseline and 6 months
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Change in Perceived Stress Scale (PSS-14).
Values ranging 0-56, with lower scores indicating a better outcome.
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Baseline and 6 months
|
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Change in Positive Mental Health
時間枠：Baseline and 6 months
|
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
|
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Change in Depressive Symptoms
時間枠：Baseline and 6 months
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Change in Geriatric Depression Scale (GDS-15).
Values ranging 0-15, with lower scores indicating a better outcome.
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Baseline and 6 months
|
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Change in Physical functioning
時間枠：Baseline and 6 months
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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.
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Baseline and 6 months
|
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Change in Hand Grip Strength
時間枠：Baseline and 6 months
|
Change in maximum hand grip strength assessed using a hydraulic hand dynamometer.
Higher values indicate greater muscle strength.
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Baseline and 6 months
|
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Change in Mobility
時間枠：Baseline and 6 months
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Change in time required to complete the Timed Up and Go test.
Lower values indicate better mobility.
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Baseline and 6 months
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Change in Daily functioning
時間枠：Baseline and 6 months
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Change in Basic and Instrumental Activities of Daily Living (I/ADL).
Higher scores indicate greater independence.
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Baseline and 6 months
|
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Change in Balance Confidence
時間枠：Baseline and 6 months
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Activities-specific Balance Confidence (ABC) Scale (0-100%).
Higher scores indicate greater confidence.
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Baseline and 6 months
|
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Falls
時間枠：Baseline to 12 months
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Self-reported incidence of falls
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Baseline to 12 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Bodily Pain
時間枠：Baseline, 6 months, and 12 months
|
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.
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Baseline, 6 months, and 12 months
|
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Change in Caregiving Experience
時間枠：Baseline, 6 months, and 12 months
|
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.
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Baseline, 6 months, and 12 months
|
|
Change in Sleep Duration
時間枠：Baseline, 6 months, and 12 months
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Change in self-reported hours of sleep per night.
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Baseline, 6 months, and 12 months
|
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Change in Blood Pressure
時間枠：Baseline, 6 months, and 12 months
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Systolic and diastolic blood pressure measured using standardized procedures
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Baseline, 6 months, and 12 months
|
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Change in Physical activity
時間枠：12 months
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Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ).
Higher scores indicate higher levels of physical activity.
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12 months
|
|
Change in Self-Determined Motivation for Physical Activity
時間枠：12 months
|
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
時間枠：12 months
|
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
時間枠：12 months
|
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
時間枠：12 months
|
Change in Geriatric Depression Scale (GDS-15).
Values ranging 0-15, with lower scores indicating a better outcome.
|
12 months
|
|
Change in Physical functioning
時間枠：12 months
|
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
時間枠：12 months
|
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.
時間枠：12 months
|
Change in time required to complete the Timed Up and Go test.
Lower values indicate better mobility.
|
12 months
|
|
Change in Daily functioning
時間枠：12 months
|
Change in Basic and Instrumental Activities of Daily Living (I/ADL).
Higher scores indicate greater independence.
|
12 months
|
|
Change in Balance confidence
時間枠：12 months
|
Activities-specific Balance Confidence (ABC) Scale (0-100%).
Higher scores indicate greater confidence.
|
12 months
|
|
Change in Cognitive performance
時間枠：Baseline, 6 months, and 12 months
|
Change in Montreal Cognitive Assessment (MoCA) total score (range 0-30).
Higher scores indicate better cognitive function.
|
Baseline, 6 months, and 12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- R26019
- 360990 (その他の助成金/資金番号：Research Council of Finland)
- 360824 (その他の助成金/資金番号：Research Council of Finland)
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IPD プランの説明
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