Rehab2life: Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
Study Details
Study Description
Brief Summary
The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home-based pulmonary rehabilitation Participants will undergo an initial respiratory rehabilitation program for 8 weeks, which may be in a home or hospital context, according to clinical criteria defined in the technical guidance of the general health department 14/2019 - Pulmonary Rehabilitation Programs in Primary Health Care. At the end of the 8 weeks, the groups will be randomly divided, with one part receiving the maintenance respiratory rehabilitation program. |
Other: Pulmonary rehabilitation programme
Educational support, exercise training, behaviour change intervention, self-management, integrated action plan either home-based or centre-based, depending on clinical criteria (FEV1, SO2). Maintenance home-based pulmonary rehabilitation programme for 10 months with alternate supervision
Other Names:
|
| Active Comparator: Usual care Participants will undergo an initial respiratory rehabilitation program for 8 weeks, which may be in a home or hospital context, according to clinical criteria defined in the technical guidance of the general health department 14/2019 - Pulmonary Rehabilitation Programs in Primary Health Care. At the end of the 8 weeks, the groups will be randomly divided, with one part receiving the usual care. |
Other: Usual Care
Educational support, exercise training, behaviour change intervention, self-management, integrated action plan either home-based or centre-based, depending on clinical criteria (FEV1, SO2). No maintenance programme, the patient has the usual medical consults
|
Outcome Measures
Primary Outcome Measures
- Distance in meters covered over a time of 6 minutes 0 [Baseline]
6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
- Distance in meters covered over a time of 6 minutes 1 [8 weeks]
6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
- Distance in meters covered over a time of 6 minutes 2 [7 months]
6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
- Distance in meters covered over a time of 6 minutes 3 [12 months]
6 minute walking test (6MWT) - The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Secondary Outcome Measures
- Dyspnoea 0 [Baseline]
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
- Dyspnoea 1 [8 weeks]
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
- Dyspnoea 2 [7 months]
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
- Dyspnoea 3 [12 months]
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
- Health-Related Quality of Life 0 [Baseline]
European quality of life-5 dimensions (EQ5D)
- Health-Related Quality of Life 1 [8 weeks]
European quality of life-5 dimensions (EQ5D)
- Health-Related Quality of Life 2 [7 months]
European quality of life-5 dimensions (EQ5D)
- Health-Related Quality of Life 3 [12 months]
European quality of life-5 dimensions (EQ5D)
- Number of emergency department visits due to COPD exacerbation 0 [Baseline]
Number of exacerbations (accessing to emergency department)
- Number of emergency department visits due to COPD exacerbation 1 [8 weeks]
Number of exacerbations (accessing to emergency department)
- Number of emergency department visits due to COPD exacerbation 2 [7 months]
Number of exacerbations (accessing to emergency department)
- Number of emergency department visits due to COPD exacerbation 3 [12 months]
Number of exacerbations (accessing to emergency department)
- COPD symptom control 0 [Baseline]
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
- COPD symptom control 1 [8 weeks]
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
- COPD symptom control 2 [7 months]
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
- COPD symptom control 3 [12 months]
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
- Anxiety and Depression 0 [Baseline]
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
- Anxiety and Depression 1 [8 weeks]
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
- Anxiety and Depression 2 [7 months]
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
- Anxiety and Depression 3 [12 months]
Hospital Anxiety and Depression Scale (HADS) - HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring
- Physical activity 0 [Baseline]
Counting steps per day with the pedometer Yamax EX510
- Physical activity 1 [8 weeks]
Counting steps per day with the pedometer Yamax EX510
- Physical activity 2 [7 months]
Counting steps per day with the pedometer Yamax EX510
- Physical activity 3 [12 months]
Counting steps per day with the pedometer Yamax EX510
Eligibility Criteria
Criteria
Inclusion Criteria:
-
COPD diagnose with B, C ou D characterization according to GOLD criteria;
-
Residence in the area covered by the institution where the study is carried out
Exclusion Criteria:
-
COPD exacerbation for less than 1 week;
-
Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute exclusion criteria);
-
Presence of comorbidities that constitute relative exclusion criteria, thorough a medical evaluation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unidade Local de Saúde de Matosinhos | Matosinhos | Porto | Portugal | 4450 |
Sponsors and Collaborators
- Unidade Local de Saúde de Matosinhos, EPE
Investigators
- Principal Investigator: Liliana Silva, MSc, Matosinhos Local Health Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 136/CES/JAS