Pulmonary Disease, Chronic ObstructiveCARE2CARERNCT07791147
Family-centred Pulmonary Rehabilitation to Empower Carers
A study testing Carer inclusive pulmonary rehabilitation and Pulmonary rehabilitation in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Aveiro University at 7 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Asthma
- What is being tested?
- Carer inclusive pulmonary rehabilitation and Pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesPortugal
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Portugal7 sites
Unidade Local de Saúde Região de Aveiro
Aveiro, Aveiro District, 3814-501
Maria Aurora Mendes, (+351)234378360, mamendes88@gmail.com
Laboratório de Investigação e Reabilitação Respiratória da Escola Superior de Saúde da Universidade de Aveiro Lab3R-ESSUA
Aveiro, 3810-193
Alda Marques, (+351)234372462, amarques@ua.pt
Unidade Local de Saúde Baixo Mondego
Figueira da Foz Municipality, Coimbra District, 3094-001
Vitória Martins, (+351)924720449, vitoria.b.martins@gmail.com
Unidade Local de Saúde Santa Maria
Lisbon, Lisbon District, 1649-035
Maria Fátima Rodrigues, (351)217548042, fatima.pneumo@gmail.com
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality, Porto District, 4464-513
Paula Simão, (+351)229391729, simao.paula@gmail.com
Unidade Local de Saúde Entre o Douro e Vouga
Santa Maria da Feira, Aveiro District, 4520-211
Rita Gomes, (+351)256379700, gomes.rita.dm@gmail.com
Unidade Local de Saúde de Gaia e Espinho
Vila Nova de Gaia, Porto District, 4434-502
Inês C Sanches, (+351)227865100, ines.sanches@ulsge.min-saude.pt
About this study
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.
Read the detailed description
Chronic respiratory disease is an umbrella term for conditions affecting the lungs and airways, including chronic obstructive pulmonary disease, interstitial lung diseases, asthma, and lung cancer, which are leading causes of mortality and impose a substantial societal burden worldwide.
The natural course of a chronic respiratory disease is progressive, with dynamic and unexpected declines, shifting among acute, stable and serious phases. Dependence on others begins early, and more than 70% of people with chronic respiratory disease rely on informal care. Informal carers, i.e., relatives, partners and friends in unpaid roles, have a wide range of responsibilities including gathering disease and treatment information; managing medication, appointments, symptoms and exacerbations; supporting treatment adherence and healthy lifestyles; handling household tasks; overseeing equipment, finances and decisions. The support provided by informal carers has been shown to improve health outcomes, improve treatment adherence, and promote healthier lifestyles in people with chronic respiratory diseases, easing pressure on healthcare systems.
Despite many positive caregiving experiences, informal carers face significant challenges due to their extensive responsibilities, and support interventions remain scarce. 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. Involving informal carers in the education and psychosocial support sessions has been shown to improve family coping and adjustment. However, these sessions primarily focus on patient-related topics, such as information about the disease, treatments, healthy lifestyles, symptom management, and emotional support. Although these topics are also relevant to informal carers, they are not tailored to their specific needs. Furthermore, it is equally important to address topics that focus on carers' own needs to safeguard their health and strengthen their ability to provide care.
This study will therefore redesign pulmonary rehabilitation to act as a dual-support mechanism for both people with a chronic respiratory disease and their carers. The primary objective of the study is to assess the effects of carer inclusive pulmonary rehabilitation on preparedness for caregiving. Secondary aims are to explore the effects of carer inclusive pulmonary rehabilitation on informal carers' burden, fatigue, symptoms of anxiety and depression, health-related quality of life, disease knowledge, health literacy and self-efficacy; and on people with chronic respiratory disease's functional capacity, muscle strength, impact of the disease, fatigue, symptoms of anxiety and depression, health-related quality of life, disease knowledge, health literacy and self-efficacy.
A total of 120 patient-informal carer dyads will be randomly assigned (1:1) to either a 12-week carer inclusive pulmonary rehabilitation programme or a 12-week standard pulmonary rehabilitation programme (60 dyads per group). 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
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Asthma, Lung Neoplasms, Bronchiectasis
- Being tested
- Carer inclusive pulmonary rehabilitation, Pulmonary rehabilitation
- Keywords
- Caregivers, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Asthma, Lung Neoplasms, Bronchiectasis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Asthma, Lung Neoplasms, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carer inclusive pulmonary rehabilitationBehavioural
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 rehabilitationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Both individuals with chronic respiratory disease and their informal carers will participate in the pulmonary rehabilitation programme. Receives: 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. Receives: Behavioral: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 months (immediately after intervention)
Secondary outcomes (14)
Short-Form Zarit Burden Interview
Assessed in informal carers. The Short-Form Zarit Burden Interview is a 12-item self-report questionnaire that measures carer burden. 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 12 items, with higher scores indicating greater burden.
Measured: baseline and 3 months (immediately after intervention)
Hospital Anxiety and Depression Scale
Assessed in informal carers and people with chronic respiratory disease. The Hospital Anxiety and Depression Scale has 14 items: 7 measuring symptoms of anxiety (HADS-A) and another 7 measuring symptoms of depression (HADS-D). Score ranges from 0 (minimum symptom overload) to 21 (maximum symptom overload) for the HADS-A and HADS-D.
Measured: baseline and 3 months (immediately after intervention)
EQ-5D-5L
Assessed in informal carers and people with chronic respiratory disease. The EQ-5D-5L self-report questionnaire comprised two components: the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The descriptive system measures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions can be combined in a 5-digit code and converted to an index score. Higher scores in the index and EQ-VAS indicate better health-related quality of life.
Measured: baseline and 3 months (immediately after intervention)
Lung Information Needs Questionnaire
Assessed in informal carers and people with chronic respiratory disease. The Lung Information Needs Questionnaire is a self-administered questionnaire that assesses information needs. It consists of 16 questions across six domains: disease knowledge, medicines, self-management, smoking, exercise, and diet. Higher scores indicate greater information and education needs.
Measured: baseline and 3 months (immediately after intervention)
Health Literacy Survey Questionnaire - 12 items
Assessed in informal carers and people with chronic respiratory disease. The Health Literacy Survey Questionnaire - 12 items is a 12-item self-report questionnaire that measures general health literacy. Each item is rated on a 4-point Likert scale. The score is calculated as the percentage of items with valid responses that were answered with "very easy" or "easy". Higher scores indicate a higher level of general health literacy.
Measured: baseline and 3 months (immediately after intervention)
Functional Assessment of Chronic Illness Therapy - fatigue subscale (FACIT-FS)
Assessed in informal carers and people with chronic respiratory disease. The Functional Assessment of Chronic Illness Therapy - fatigue subscale (FACIT-FS) assesses physical, functional and emotional fatigue and its social consequences. The total score ranges from 0 to 52, higher scores indicate less fatigue.
Measured: baseline and 3 months (immediately after intervention)
Chronic Airway Assessment Test
Assessed in people with chronic respiratory disease. The Chronic Airway Assessment Test is an 8-item questionnaire that assesses the overall impact of the disease on health status. The score ranges from 0 to 40, and higher values indicate a more severe impact of the disease.
Measured: baseline and 3 months (immediately after intervention)
Handgrip muscle strength
Assessed in people with chronic respiratory disease. Handgrip muscle strength will be measured with a dynamometer (Baseline Hydraulic Hand Dynamometer).
Measured: baseline and 3 months (immediately after intervention)
Quadriceps maximal voluntary contraction
Assessed in people with chronic respiratory disease. Quadriceps maximal voluntary contraction (QMVC) will be measured during a maximum isometric voluntary contraction with a digital dynamometer (microFET2, Hoggan Health, Salt Lake City, Utah) in kilograms-force (KgF) on the dominant side.
Measured: baseline and 3 months (immediately after intervention)
6-min walk test (6MWT)
Assessed in people with chronic respiratory disease. The 6MWT is a submaximal test that assesses functional exercise tolerance. Participants will be instructed to walk as far as possible in a 30-m flat corridor for 6 minutes.
Measured: baseline and 3 months (immediately after intervention)
1-min sit-to-stand test (1minSTS)
Assessed in people with chronic respiratory disease. The 1minSTS assesses functional capacity, focusing on a different activity of daily living - sitting and standing from a chair. Participants will be instructed to stand up and sit down as many times as possible in 1 minute.
Measured: baseline and 3 months (immediately after intervention)
Short Physical Performance Battery (SPPB)
Assessed in people with chronic respiratory disease. 4meters gait speed (s) | Standing balance | Five repetitions sit-to-stand (5STS) (s), score 0-12 4meters gait speed: Time that individuals take to walk down a 4-m track at their usual pace, walking past the end of the track before stopping is registered and scored 1 to 4; Balance: 10s are registered in side-by-side stand, in semi-tandem and in tandem position and scored 0 to 2 5STS: Time taken to perform 5 repetitions is score 1 to 4
Measured: baseline and 3 months (immediately after intervention)
General Self-Efficacy (GSE)
Assessed in informal carers. The GSE is a 10-item, self-administered questionnaire that measures an individual's belief in their own ability to respond to novel or difficult situations and to deal with associated obstacles or setbacks. Each item is rated on a 4-point Likert scale, ranging from 'Not at all true' (1) to 'Exactly true' (4). The total score is calculated by summing the scores for all 10 items, with higher scores indicating a greater sense of self-efficacy.
Measured: baseline and 3 months (immediately after intervention)
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE)
Assessed in people with chronic respiratory disease. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is a 15-item questionnaire that measures the individual's confidence in managing their health and completing the pulmonary rehabilitation programme. The total score ranges from 15 to 60 points; higher scores indicate better self-efficacy and confidence.
Measured: baseline and 3 months (immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde Matosinhos, Unidade Local de Saúde Gaia/Espinho, Unidade Local de Saúde da Região de Aveiro, Unidade Local de Saúde do Baixo Mondego, Unidade Local de Saúde Santa Maria, Unidade Local de Saude Entre o Douro e Vouga
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791147
- Sponsor's protocol ID
- 2024.14722.PEX
- Acronym
- CARE2CARER
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-centred Pulmonary Rehabilitation to Empower Carers
- ClinicalTrials.gov ID
- NCT07791147
- Acronym / sponsor ID
- CARE2CARER / 2024.14722.PEX
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Asthma, Lung Neoplasms, Bronchiectasis
- Keywords
- Caregivers, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Asthma, Lung Neoplasms, Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde Matosinhos, Unidade Local de Saúde Gaia/Espinho, Unidade Local de Saúde da Região de Aveiro, Unidade Local de Saúde do Baixo Mondego, Unidade Local de Saúde Santa Maria, Unidade Local de Saude Entre o Douro e Vouga
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic respiratory disease is an umbrella term for conditions affecting the lungs and airways, including chronic obstructive pulmonary disease, interstitial lung diseases, asthma, and lung cancer, which are leading causes of mortality and impose a substantial societal burden worldwide.
The natural course of a chronic respiratory disease is progressive, with dynamic and unexpected declines, shifting among acute, stable and serious phases. Dependence on others begins early, and more than 70% of people with chronic respiratory disease rely on informal care. Informal carers, i.e., relatives, partners and friends in unpaid roles, have a wide range of responsibilities including gathering disease and treatment information; managing medication, appointments, symptoms and exacerbations; supporting treatment adherence and healthy lifestyles; handling household tasks; overseeing equipment, finances and decisions. The support provided by informal carers has been shown to improve health outcomes, improve treatment adherence, and promote healthier lifestyles in people with chronic respiratory diseases, easing pressure on healthcare systems.
Despite many positive caregiving experiences, informal carers face significant challenges due to their extensive responsibilities, and support interventions remain scarce. 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. Involving informal carers in the education and psychosocial support sessions has been shown to improve family coping and adjustment. However, these sessions primarily focus on patient-related topics, such as information about the disease, treatments, healthy lifestyles, symptom management, and emotional support. Although these topics are also relevant to informal carers, they are not tailored to their specific needs. Furthermore, it is equally important to address topics that focus on carers' own needs to safeguard their health and strengthen their ability to provide care.
This study will therefore redesign pulmonary rehabilitation to act as a dual-support mechanism for both people with a chronic respiratory disease and their carers. The primary objective of the study is to assess the effects of carer inclusive pulmonary rehabilitation on preparedness for caregiving. Secondary aims are to explore the effects of carer inclusive pulmonary rehabilitation on informal carers' burden, fatigue, symptoms of anxiety and depression, health-related quality of life, disease knowledge, health literacy and self-efficacy; and on people with chronic respiratory disease's functional capacity, muscle strength, impact of the disease, fatigue, symptoms of anxiety and depression, health-related quality of life, disease knowledge, health literacy and self-efficacy.
A total of 120 patient-informal carer dyads will be randomly assigned (1:1) to either a 12-week carer inclusive pulmonary rehabilitation programme or a 12-week standard pulmonary rehabilitation programme (60 dyads per group). 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Carer inclusive pulmonary rehabilitationBoth individuals with chronic respiratory disease and their informal carers will participate in the pulmonary rehabilitation programme. |
| Control group | Other | Behavioral: Pulmonary rehabilitationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Aged 18 years or older
- Diagnosis of chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, asthma, or lung cancer.
Key exclusion criteria (8 listed)
- Unable to provide informed consent
- Signs of cognitive impairment
- Unable to provide informed consent
- Signs of cognitive impairment
- Participated in a pulmonary rehabilitation programme within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carer inclusive pulmonary rehabilitationPeople 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. | Behavioural | Experimental group |
| Pulmonary rehabilitationThe 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. | Behavioural | Control group |
Primary outcome
Preparedness for caregiving scale
Time frame: baseline and 3 months (immediately after intervention)
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.
14 secondary outcomes
Short-Form Zarit Burden Interview
Time frame: baseline and 3 months (immediately after intervention)
Hospital Anxiety and Depression Scale
Time frame: baseline and 3 months (immediately after intervention)
EQ-5D-5L
Time frame: baseline and 3 months (immediately after intervention)
Lung Information Needs Questionnaire
Time frame: baseline and 3 months (immediately after intervention)
Health Literacy Survey Questionnaire - 12 items
Time frame: baseline and 3 months (immediately after intervention)
Functional Assessment of Chronic Illness Therapy - fatigue subscale (FACIT-FS)
Time frame: baseline and 3 months (immediately after intervention)
Chronic Airway Assessment Test
Time frame: baseline and 3 months (immediately after intervention)
Handgrip muscle strength
Time frame: baseline and 3 months (immediately after intervention)
Quadriceps maximal voluntary contraction
Time frame: baseline and 3 months (immediately after intervention)
6-min walk test (6MWT)
Time frame: baseline and 3 months (immediately after intervention)
1-min sit-to-stand test (1minSTS)
Time frame: baseline and 3 months (immediately after intervention)
Short Physical Performance Battery (SPPB)
Time frame: baseline and 3 months (immediately after intervention)
General Self-Efficacy (GSE)
Time frame: baseline and 3 months (immediately after intervention)
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE)
Time frame: baseline and 3 months (immediately after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carer inclusive pulmonary rehabilitation and Pulmonary rehabilitation in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Aveiro University at 7 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alda Marques ((+351)234372462, amarques@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparedness for caregiving scale (time frame: baseline and 3 months (immediately after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.