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Physical Activity Intervention for Older Family Carers (CAREFIT)

11 de junho de 2026 atualizado por: 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Tiia Ngandu, MD, PhD
  • Número de telefone: +358 29 524 7716
  • E-mail: tiia.ngandu@thl.fi

Locais de estudo

  • Finlândia
      • Tampere, Finlândia, 33520
        • Tampere University
        • Contato:
        • Contato:
        • Investigador principal:
          • Jenni Kulmala, PhD, Professor

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Comparador Ativo: 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.
Comportamental: Health education
General health advice provided at baseline and referral to a web-based educational programme

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of participants successfully recruited
Prazo: 3-month recruitment period
Ability to enroll the planned number of participants (n=50) within the recruitment period.
3-month recruitment period
Retention rate
Prazo: 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
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Physical Activity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and 6 months
Change in hair cortisol concentration (HCC) measured from hair samples.
Baseline and 6 months
Change in Stress-Related Symptoms
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and 6 months
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
Baseline and 6 months
Falls
Prazo: Baseline to 12 months
Self-reported incidence of falls
Baseline to 12 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in Bodily Pain
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 12 months
Change in Basic and Instrumental Activities of Daily Living (I/ADL). Higher scores indicate greater independence.
12 months
Change in Balance confidence
Prazo: 12 months
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
12 months
Change in Cognitive performance
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tampere University

Colaboradores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

31 de agosto de 2027

Conclusão do estudo (Estimado)

31 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R26019
  • 360990 (Número de outro subsídio/financiamento: Research Council of Finland)
  • 360824 (Número de outro subsídio/financiamento: Research Council of Finland)

Plano para dados de participantes individuais (IPD)

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INDECISO

Descrição do plano IPD

IPD may not be shared due to privacy considerations

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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