Family-centred Pulmonary Rehabilitation to Empower Carers

NCT07791147 | Not Yet Recruiting

• 1 other identifier: 2024.14722.PEX
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Lung Diseases, Interstitial; Asthma; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Bronchiectasis

Keywords

Caregivers; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Asthma; Lung Neoplasms; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Preparedness for caregiving scale

  Assessed in informal carers. The Preparedness for Caregiving Scale is an eight-item self-report questionnaire that measures caregivers' perceived preparedness to provide physical and emotional care, coordinate services, manage stress, respond to emergencies, navigate the healthcare system, and their overall preparedness for caregiving. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated by summing the scores for all eight items, with higher scores indicating greater perceived preparedness for caregiving.

  baseline and 3 months (immediately after intervention)

Secondary Outcomes (14)

• Short-Form Zarit Burden Interview

  baseline and 3 months (immediately after intervention)

• Hospital Anxiety and Depression Scale

  baseline and 3 months (immediately after intervention)

• EQ-5D-5L

  baseline and 3 months (immediately after intervention)

• Lung Information Needs Questionnaire

  baseline and 3 months (immediately after intervention)

• Health Literacy Survey Questionnaire - 12 items

  baseline and 3 months (immediately after intervention)

Study Arms (2)

Experimental group

EXPERIMENTAL

Both individuals with chronic respiratory disease and their informal carers will participate in the pulmonary rehabilitation programme.

Behavioral: Carer inclusive pulmonary rehabilitation

Control group

OTHER

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.

Behavioral: Pulmonary rehabilitation

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.

Experimental group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informal carers:
• Aged 18 years or older.
• Providing unpaid informational, physical, practical, emotional, social, or financial support to a person with a chronic respiratory disease.
• Identified by the patient as the primary informal carer
• Patients:
• Aged 18 years or older
• Diagnosis of chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, asthma, or lung cancer.
• Clinically stable in the previous month (no changes in medication or occurrence of exacerbations)
• Referred for pulmonary rehabilitation.
• Report having an informal carer

You may not qualify if:

• Informal carers:
• Unable to provide informed consent
• Signs of cognitive impairment
• Patients:
• Unable to provide informed consent
• Signs of cognitive impairment
• Participated in a pulmonary rehabilitation programme within the last 6 months
• Neoplastic or immunological disease, or an unstable or significant cardiac, musculoskeletal, neuromuscular, or psychiatric condition that limits the ability to participate in the pulmonary rehabilitation programme.

Sponsors & Collaborators

• Aveiro University: lead
• Unidade Local de Saúde Matosinhos: collaborator
• Unidade Local de Saúde Gaia/Espinho: collaborator
• Unidade Local de Saúde da Região de Aveiro: collaborator
• Unidade Local de Saúde do Baixo Mondego: collaborator
• Unidade Local de Saúde Santa Maria: collaborator
• Unidade Local de Saude Entre o Douro e Vouga: collaborator

Study Sites (7)

Unidade Local de Saúde Região de Aveiro

Aveiro, Aveiro District, 3814-501, Portugal

Location

Unidade Local de Saúde Entre o Douro e Vouga

Santa Maria da Feira, Aveiro District, 4520-211, Portugal

Location

Unidade Local de Saúde Baixo Mondego

Figueira da Foz Municipality, Coimbra District, 3094-001, Portugal

Location

Unidade Local de Saúde Santa Maria

Lisbon, Lisbon District, 1649-035, Portugal

Location

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Porto District, 4464-513, Portugal

Location

Unidade Local de Saúde de Gaia e Espinho

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Laboratório de Investigação e Reabilitação Respiratória da Escola Superior de Saúde da Universidade de Aveiro Lab3R-ESSUA

Aveiro, 3810-193, Portugal

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Asthma; Lung Neoplasms; Bronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Alda Marques

CONTACT

(+351)234372462; amarques@ua.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (7)