Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Conditions
Keywords
COPD, Pulmonary rehabilitation, Maintenance pulmonary rehabilitation
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.
Interventions
OTHERMaintenance programme
Continuous educational support, exercise training, behaviour change intervention, and self-management. Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision
OTHERUsual Care
No maintenance programme, and the patient has the usual follow-up and medical appointments
Sponsors
Unidade Local de Saúde de Matosinhos, EPE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome evaluation will be performed by a cardiopulmonary technician that has no information about the patient group
Intervention model description
Randomization will be performed after verifying the inclusion and exclusion criteria in the study and the informed, free and informed consent of the individuals. Randomization will be carried out by permuted blocks of 4 to guarantee the same number of participants in each group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD diagnose with B or E characterization according to GOLD criteria; * Residence in the area covered by the institution where the study is carried out
Exclusion criteria
* Frequency of a PR programme in the previous six months * COPD exacerbation for less than one week; * Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance in meters covered over a time of 6 minutes 0 | Baseline | Distance in meters covered over a time of 6 minutes 0 measured with the 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 | Distance in meters covered over a time of 6 minutes 1 measured with the 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 | Distance in meters covered over a time of 6 minutes 2 measured with the 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 | Distance in meters covered over a time of 6 minutes 3 measured with the 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
| Measure | Time frame | Description |
|---|---|---|
| Number of emergency department visits due to COPD exacerbation 1 | 8 weeks | Number of exacerbations (accessing to emergency department) |
| 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) |
| 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 |
| Health-Related Quality of Life 1 | 8 weeks | European quality of life-5 dimensions (EQ5D) |
| 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 |
| Functional capacity 0 | Baseline | Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
| Functional capacity 1 | 8 weeks | Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
| Functional capacity 2 | 7 months | Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
| Functional capacity 3 | 12 months | Number of times per minute an individual is able to stand up and sit down on a chair standardised for height |
| 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 |
| 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) |
Countries
Portugal
Contacts
Primary ContactLiliana Silva, MSc
Backup ContactMiguel Padilha, PhD
Outcome results
None listed