An interventional study of Maintenance programme and Usual Care in Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, sponsored by Unidade Local de Saúde de Matosinhos, EPE. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Unidade Local de Saúde de Matosinhos, EPE · Not applicable, Interventional, and Treatment
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 160 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Unidade Local de Saúde de Matosinhos, EPE is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks. At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care. The maintenance arm will receive home visits for supervised physical exercise and progressively alternated with phone calls to motivation and feedback
Other: Maintenance programme
Participants will undergo an initial home-based pulmonary rehabilitation program for eight weeks. At the end of the eight weeks, the participants will be randomly assigned into two groups, one receiving the maintenance pulmonary rehabilitation program and the other receiving the usual care. The control group will have access to the usual follow.
Other: Usual Care
Continuous educational support, exercise training, behaviour change intervention, and self-management. Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision
Also known as: Physical exercise, Behaviour change, Self-management
No maintenance programme, and the patient has the usual follow-up and medical appointments
Distance in meters covered over a time of 6 minutes 0
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.
Time frame: Baseline
Distance in meters covered over a time of 6 minutes 1
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.
Time frame: 8 weeks
Distance in meters covered over a time of 6 minutes 2
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.
Time frame: 7 months
Distance in meters covered over a time of 6 minutes 3
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.
Time frame: 12 months
Dyspnoea 0
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time frame: Baseline
Dyspnoea 1
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time frame: 8 weeks
Dyspnoea 2
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time frame: 7 months
Dyspnoea 3
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time frame: 12 months
Health-Related Quality of Life 0
European quality of life-5 dimensions (EQ5D)
Time frame: Baseline
Health-Related Quality of Life 1
European quality of life-5 dimensions (EQ5D)
Time frame: 8 weeks
Health-Related Quality of Life 2
European quality of life-5 dimensions (EQ5D)
Time frame: 7 months
Health-Related Quality of Life 3
European quality of life-5 dimensions (EQ5D)
Time frame: 12 months
Number of emergency department visits due to COPD exacerbation 0
Number of exacerbations (accessing to emergency department)
Time frame: Baseline
Number of emergency department visits due to COPD exacerbation 1
Number of exacerbations (accessing to emergency department)
Time frame: 8 weeks
Number of emergency department visits due to COPD exacerbation 2
Number of exacerbations (accessing to emergency department)
Time frame: 7 months
Number of emergency department visits due to COPD exacerbation 3
Number of exacerbations (accessing to emergency department)
Time frame: 12 months
COPD symptom control 0
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: Baseline
COPD symptom control 1
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: 8 weeks
COPD symptom control 2
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: 7 months
COPD symptom control 3
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time frame: 12 months
Anxiety and Depression 0
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
Time frame: Baseline
Anxiety and Depression 1
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
Time frame: 8 weeks
Anxiety and Depression 2
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
Time frame: 7 months
Anxiety and Depression 3
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
Time frame: 12 months
Physical activity 0
Counting steps per day with the pedometer Yamax EX510
Time frame: Baseline
Physical activity 1
Counting steps per day with the pedometer Yamax EX510
Time frame: 8 weeks
Physical activity 2
Counting steps per day with the pedometer Yamax EX510
Time frame: 7 months
Physical activity 3
Counting steps per day with the pedometer Yamax EX510
Time frame: 12 months
Functional capacity 0
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: Baseline
Functional capacity 1
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: 8 weeks
Functional capacity 2
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: 7 months
Functional capacity 3
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time frame: 12 months
Plan to share: No
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Unidade Local de Saúde de Matosinhos, EPE