An interventional study of Carer inclusive pulmonary rehabilitation and Pulmonary rehabilitation in Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial and Asthma, sponsored by Aveiro University. Not yet recruiting at 7 sites in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Aveiro University · Not applicable, Interventional, and Other
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Aveiro University is the lead sponsor of 59 studies on the registry; 14 are open to participants now.
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Participants will be recruited as patient-informal carer dyads. Informal carers will be identified by a person with a chronic respiratory disease referred for pulmonary rehabilitation.
Inclusion Criteria
Informal carers:
Patients:
Exclusion Criteria
Informal carers:
Patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Both individuals with chronic respiratory disease and their informal carers will participate in the pulmonary rehabilitation programme.
Behavioral: Carer inclusive pulmonary rehabilitation
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
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.
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.
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.
Time frame: baseline and 3 months (immediately after intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline and 3 months (immediately after intervention)
Plan to share: No
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Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 6 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Aveiro University