An interventional study of Home-based pulmonary rehabilitation in COPD, sponsored by Polytechnic Institute of Porto. Recruiting at 1 site in Portugal. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-19.
Sponsored by Polytechnic Institute of Porto · Not applicable, Interventional, and Treatment
This project aims to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation (PR) program (reabilitAR) in patients with chronic obstructive pulmonary disease (COPD). It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
Patients will be recruited at hospitals. Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered. Then, patients will be entered into the reabilitAR program (12 weeks). The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. After 12 weeks all outcome measures will be reassessed.
It is expected that the home-based approach will express benefits and reflect the concerns to provide appropriate responses to the patient's needs by increasing access to PR.
The World Health Organization (WHO) indicates that hundreds of millions of people worldwide are affected by chronic respiratory diseases (CRD), including chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) is an essential component in the management of CRD with the aim to improve patients' exercise and functional capacity and psychological condition with long-term adherence to health-enhancing behaviors, including exercise training and self-management skills.
However, despite the well-known evidence, this service is mostly underutilized due to poor accessibility, with only 1% of worldwide availability of PR services for COPD patients. Thus, is important to undertake actions that improve access to and delivery of PR services for suitable patients. One of the strategies in the international guidelines is the creation of new models of programs, where a home-based approach is indicated.
The aim of this project is to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation program (reabilitAR) in patients with COPD. It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
The plan is to recruit the maximum of patients with COPD via clinicians at hospitals. This study will enroll adult patients with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Patients will be referred by pulmonologists, from medical consultation in hospitals and clinics in Portugal. With the referral, it is expected that the medical doctor explains the goal and benefits of PR. Eligible patients will be contacted by the reabilitAR team, for additional questions and to begin the integration process.
Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered.
The program consists in home visits for the exercise training and the self-management sessions, and motivational phone-calls including the follow-up of the clinical condition, the progression of exercise training, including a total of 14 home visits, with more visits in the first two weeks of the program (4 visits). From the third week, one visit will be replaced by a phone call, for a total of 10 phone calls.
After 12 weeks all outcome measures will be reassessed.
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 50 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Polytechnic Institute of Porto is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Patients will be treated for 12 weeks. The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD.
Other: Home-based pulmonary rehabilitation
The reabilitAR program includes the self-management educational program Living Well with COPD. The exercise training will include endurance, resistance/strength, flexibility and balance training.
Change from baseline number of steps (incremental step test) at 12 weeks
The incremental step test will be used to assess exercise capacity
Time frame: At baseline and up to 12 weeks
Change from baseline number of repetitions (1-minute sit-to-stand test) at 12 weeks
The 1-minute sit-to-stand test will be used to assess functional capacity
Time frame: At baseline and up to 12 weeks
Change from baseline score of CAT at 12 weeks
COPD Assessment Test (CAT) will be used to assess impact of the disease. The individual score of each item is added to provide a total score that can range from 0 to 40. Total scores inferior to 10 are considered as "reduced impact", from 10-20 as "medium impact", from 21- 30 as "high impact" and above 30 as "very high impact".
Time frame: At baseline and up to 12 weeks
Change from baseline score of dyspnea at 12 weeks
Modified Borg scale will be used to assess patients' level of dyspnea. 0-10 scale is used to measure perceived dyspnea where 0 is "not at all" and 10 is "maximal"
Time frame: At baseline and up to 12 weeks
Change from baseline score of fatigue at 12 weeks
Modified Borg Scale will be used to assess patients' level of fatigue. 0-10 scale is used to measure perceived fatigue where 0 is "not at all" and 10 is "maximal"
Time frame: At baseline and up to 12 weeks
Change from baseline score of London Chest Activities of Daily Living at 12 weeks
London Chest Activities of Daily Living will be used to assess patients' level of dyspnea performing activities of daily living. The individual score of each item is added to provide a total score that can range from 0 to 75 where maximal score represents a higher level of dyspnea.
Time frame: At baseline and up to 12 weeks
Change from baseline score of Hospital Anxiety and Depression Scale at 12 weeks
Hospital Anxiety and Depression Scale will be used to assess patients' emotional status. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression symptoms.
Time frame: At baseline and up to 12 weeks
Number of exacerbations
Patients' number of hospitalizations in the previous year and during the rehabilitation will be assessed by asking the patient to self-report it.
Time frame: Up to 12 weeks
Change from baseline score of mMRC at 12 weeks
Modified British Medical Research Council (mMRC) questionnaire will be used to assess patients' level of dyspnea.This questionnaire comprises five grades in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
Time frame: At baseline and up to 12 weeks
Short Form Berg Balance Scale 3 Point
Short Form Berg Balance Scale 3 Point will be used to assess patients' balance. The individual score of each item is added to provide a total score that can range from 0 to 28. Minimum score represents poor balance and maximal score represents good balance.
Time frame: At baseline
Mini-Mental State Examination (MMSE)
Mini-Mental State Examination is a 30-point questionnaire and will be used to assess patients' cognitive function. The individual score of each item is added to provide a total score that can range from 0 to 30. Total scores inferior to 9 are considered as "severe cognitive impairment", from 10-18 as "moderate cognitive impairment", from 19-23 as "mild cognitive impairment" and above 24 as "normal cognition".
Time frame: At baseline
Plan to share: No
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Pulmonary Disease, Chronic Obstructive →
Polytechnic Institute of Porto