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Physical Activity Intervention for Older Family Carers (CAREFIT)

11 juin 2026 mis à jour par: Jenni Kulmala, Tampere University

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Tiia Ngandu, MD, PhD
  • Numéro de téléphone: +358 29 524 7716
  • E-mail: tiia.ngandu@thl.fi

Lieux d'étude

  • Finlande
      • Tampere, Finlande, 33520
        • Tampere University
        • Contact:
          • Tiia Ngandu, MD, PhD
          • Numéro de téléphone: +358 29 524 7716
          • E-mail: tiia.ngandu@thl.fi
        • Contact:
        • Chercheur principal:
          • Jenni Kulmala, PhD, Professor

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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 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.
Comparateur actif: 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.
Comportemental: Health education
General health advice provided at baseline and referral to a web-based educational programme

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of participants successfully recruited
Délai: 3-month recruitment period
Ability to enroll the planned number of participants (n=50) within the recruitment period.
3-month recruitment period
Retention rate
Délai: From enrollment to the end of intervention at 6 months
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
Délai: From enrollment to the end of intervention at 6 months
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)
Délai: 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.
From enrollment to the end of intervention at 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Physical Activity
Délai: Baseline and 6 months
Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity.
Baseline and 6 months
Change in Step Count Measured by Accelerometer
Délai: Baseline and 6 months
Change in daily step count measured using the ActiGraph Link GT9X accelerometer worn continuously for seven consecutive days and nights
Baseline and 6 months
Change in Self-Determined Motivation for Physical Activity
Délai: Baseline and 6 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.
Baseline and 6 months
Change in Chronic Stress
Délai: Baseline and 6 months
Change in hair cortisol concentration (HCC) measured from hair samples.
Baseline and 6 months
Change in Stress-Related Symptoms
Délai: Baseline and 6 months
Change in Perceived Stress Scale (PSS-14). Values ranging 0-56, with lower scores indicating a better outcome.
Baseline and 6 months
Change in Positive Mental Health
Délai: 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
Change in Depressive Symptoms
Délai: Baseline and 6 months
Change in Geriatric Depression Scale (GDS-15). Values ranging 0-15, with lower scores indicating a better outcome.
Baseline and 6 months
Change in Physical functioning
Délai: Baseline and 6 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.
Baseline and 6 months
Change in Hand Grip Strength
Délai: Baseline and 6 months
Change in maximum hand grip strength assessed using a hydraulic hand dynamometer. Higher values indicate greater muscle strength.
Baseline and 6 months
Change in Mobility
Délai: Baseline and 6 months
Change in time required to complete the Timed Up and Go test. Lower values indicate better mobility.
Baseline and 6 months
Change in Daily functioning
Délai: Baseline and 6 months
Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.
Baseline and 6 months
Change in Balance Confidence
Délai: Baseline and 6 months
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
Baseline and 6 months
Falls
Délai: Baseline to 12 months
Self-reported incidence of falls
Baseline to 12 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in Bodily Pain
Délai: 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.
Baseline, 6 months, and 12 months
Change in Caregiving Experience
Délai: 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.
Baseline, 6 months, and 12 months
Change in Sleep Duration
Délai: Baseline, 6 months, and 12 months
Change in self-reported hours of sleep per night.
Baseline, 6 months, and 12 months
Change in Blood Pressure
Délai: Baseline, 6 months, and 12 months
Systolic and diastolic blood pressure measured using standardized procedures
Baseline, 6 months, and 12 months
Change in Physical activity
Délai: 12 months
Change in self-reported physical activity assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity.
12 months
Change in Self-Determined Motivation for Physical Activity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: 12 months
Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.
12 months
Change in Balance confidence
Délai: 12 months
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
12 months
Change in Cognitive performance
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tampere University

Collaborateurs

Karolinska Institutet
University of Eastern Finland
Finnish Institute for Health and Welfare

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 juin 2026

Achèvement primaire (Estimé)

31 août 2027

Achèvement de l'étude (Estimé)

31 août 2027

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

11 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R26019
  • 360990 (Autre subvention/numéro de financement: Research Council of Finland)
  • 360824 (Autre subvention/numéro de financement: Research Council of Finland)

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

IPD may not be shared due to privacy considerations

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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