Clinical trial NCT05315505: Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
Official title: Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Keywords: COPD
Pulmonary rehabilitation
Maintenance pulmonary rehabilitation
Lead sponsor: Unidade Local de Saúde de Matosinhos, EPE
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distance in meters covered over a time of 6 minutes 0
timeFrame: Baseline
measure: Distance in meters covered over a time of 6 minutes 1
timeFrame: 8 weeks
measure: Distance in meters covered over a time of 6 minutes 2
timeFrame: 7 months
measure: Distance in meters covered over a time of 6 minutes 3
timeFrame: 12 months
Secondary outcomes:
measure: Dyspnoea 0
timeFrame: Baseline
measure: Dyspnoea 1
timeFrame: 8 weeks
measure: Dyspnoea 2
timeFrame: 7 months
measure: Dyspnoea 3
timeFrame: 12 months
measure: Health-Related Quality of Life 0
timeFrame: Baseline
measure: Health-Related Quality of Life 1
timeFrame: 8 weeks
measure: Health-Related Quality of Life 2
timeFrame: 7 months
measure: Health-Related Quality of Life 3
timeFrame: 12 months
measure: Number of emergency department visits due to COPD exacerbation 0
timeFrame: Baseline
measure: Number of emergency department visits due to COPD exacerbation 1
timeFrame: 8 weeks
measure: Number of emergency department visits due to COPD exacerbation 2
timeFrame: 7 months
measure: Number of emergency department visits due to COPD exacerbation 3
timeFrame: 12 months
measure: COPD symptom control 0
timeFrame: Baseline
measure: COPD symptom control 1
timeFrame: 8 weeks
measure: COPD symptom control 2
timeFrame: 7 months
measure: COPD symptom control 3
timeFrame: 12 months
measure: Anxiety and Depression 0
timeFrame: Baseline
measure: Anxiety and Depression 1
timeFrame: 8 weeks
measure: Anxiety and Depression 2
timeFrame: 7 months
measure: Anxiety and Depression 3
timeFrame: 12 months
measure: Physical activity 0
timeFrame: Baseline
measure: Physical activity 1
timeFrame: 8 weeks
measure: Physical activity 2
timeFrame: 7 months
measure: Physical activity 3
timeFrame: 12 months
measure: Functional capacity 0
timeFrame: Baseline
measure: Functional capacity 1
timeFrame: 8 weeks
measure: Functional capacity 2
timeFrame: 7 months
measure: Functional capacity 3
timeFrame: 12 months
Other outcomes:
Locations:
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos
state: Porto
Study officials:
affiliation: Matosinhos Local Health Unit
name: Liliana Silva, MSc
role: PRINCIPAL_INVESTIGATOR
References: