Family-centred Pulmonary Rehabilitation to Empower Carers

Sponsor
Aveiro University
Study ID
NCT07791147
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carer inclusive pulmonary rehabilitation — BEHAVIORAL
    People with chronic respiratory diseases will undergo a 12-week pulmonary rehabilitation programme comprising two supervised exercise training sessions per week and one education and psychosocial support session every fortnight. Informal carers will participate in the education and psychosocial support sessions, which will be specifically designed to address both patients' and informal carers' educational and psychosocial support needs. They will also observe patients' response to exercise at the beginning, middle and end of the pulmonary rehabilitation programme. All sessions will be conducted face-to-face and will last 60-90 minutes. Exercise training sessions will be delivered by an experienced physiotherapist, following international recommendations and previous publications. A dedicated separate space for patients and for informal carers to share their experiences among their peers will be available at beginning, middle and end of the pulmonary rehabilitation programme.
  • Pulmonary rehabilitation — BEHAVIORAL
    The intervention of the control group will be the standard care, where people with chronic respiratory diseases will undergo pulmonary rehabilitation for 12 weeks. Pulmonary rehabilitation will comprise two supervised exercise training sessions per week (including endurance, resistance and functional training) and one education and psychosocial support session every fortnight. All sessions will be conducted face-to-face, with each lasting 60-90 minutes. Exercise training sessions will be delivered by an experienced physiotherapist, following international recommendations and previous publications. Informal carers will not participate in the pulmonary rehabilitation programme.

Study Details

Chronic respiratory diseases are leading causes of death and disability worldwide, imposing an enormous burden on individuals, families, and societies. Dependence on others begins early in the disease course. Over 70% of people with a chronic respiratory disease rely on informal care for daily assistance. Informal carers face multiple demands that may affect their health and ability to provide care. However, support interventions remain largely absent. Informal carers have identified pulmonary rehabilitation as an opportunity to also support them. Pulmonary rehabilitation is a cornerstone non-pharmacological intervention comprising exercise training, education, psychosocial support, and behaviour change, and is known to improve symptoms, functional capacity, quality of life, and survival. Although including informal carers in pulmonary rehabilitation has shown promising benefits for family adjustment, pulmonary rehabilitation remains patient-centred, with no dedicated support for carers' specific needs. This study will therefore redesign pulmonary rehabilitation to act as a dual-support intervention for both people with chronic respiratory disease and their informal carers. The study aims to assess the effects of carer inclusive pulmonary rehabilitation on preparedness for caregiving. A total of 120 patient-informal carer dyads will be randomly assigned to either carer inclusive pulmonary rehabilitation or standard pulmonary rehabilitation. In both groups, patients will undergo pulmonary rehabilitation. In the carer inclusive pulmonary rehabilitation group, informal carers will also participate in the education and psychosocial support sessions, which will be specifically designed to also address their needs. In the standard pulmonary rehabilitation group, informal carers will not participate in the pulmonary rehabilitation programme.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Experimental group
    Both individuals with chronic respiratory disease and their informal carers will participate in the pulmonary rehabilitation programme.
  • Other: Control group
    All individuals with chronic respiratory disease will participate in pulmonary rehabilitation. Informal carers of people with chronic respiratory disease will not participate in the pulmonary rehabilitation.

Primary Outcome Measure

Preparedness for caregiving scale [ Time Frame: baseline and 3 months (immediately after intervention) ]

Central Contacts

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