Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients

Not Applicable

Recruiting

• Conditions: Pulmonary Rehabilitation; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05315505
• Lead Sponsor: Unidade Local de Saúde de Matosinhos, EPE

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-07
• Study Start: 2022-05-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-24
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 exclusion criteria);
• Presence of comorbidities that constitute relative exclusion criteria through a medical evaluation.
• Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having a responsible caregiver and living alone
• SpO2 below 85% in the 6-minute walk test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 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 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 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 Outcome Measures

Name	Time	Method
Number of emergency department visits due to COPD exacerbation 3	12 months	Number of exacerbations (accessing to emergency department)
COPD symptom control 2	7 months	COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Physical activity 1	8 weeks	Counting steps per day with the pedometer Yamax EX510
Dyspnoea 0	Baseline	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 1	8 weeks	European quality of life-5 dimensions (EQ5D)
COPD symptom control 0	Baseline	COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
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
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)
Dyspnoea 1	8 weeks	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 2	7 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 2	7 months	Number of exacerbations (accessing to emergency department)
COPD symptom control 3	12 months	COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
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
Health-Related Quality of Life 3	12 months	European quality of life-5 dimensions (EQ5D)
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 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 2	7 months	Counting steps per day with the pedometer Yamax EX510
Number of emergency department visits due to COPD exacerbation 1	8 weeks	Number of exacerbations (accessing to emergency department)
COPD symptom control 1	8 weeks	COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Physical activity 3	12 months	Counting steps per day with the pedometer Yamax EX510
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 3	12 months	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

Trial Locations

Locations (1)

Unidade Local de Saúde de Matosinhos; 🇵🇹 Matosinhos, Porto, Portugal