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Clinical Trials/NCT05315505
NCT05315505
Recruiting
N/A

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

Unidade Local de Saúde de Matosinhos, EPE1 site in 1 country160 target enrollmentMay 9, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Unidade Local de Saúde de Matosinhos, EPE
Enrollment
160
Locations
1
Primary Endpoint
Distance in meters covered over a time of 6 minutes 2
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
April 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Unidade Local de Saúde de Matosinhos, EPE
Responsible Party
Principal Investigator
Principal Investigator

Liliana Silva

RN

Unidade Local de Saúde de Matosinhos, EPE

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

Outcomes

Primary Outcomes

Distance in meters covered over a time of 6 minutes 2

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Dyspnoea 0(Baseline)
  • Health-Related Quality of Life 1(8 weeks)
  • Number of emergency department visits due to COPD exacerbation 3(12 months)
  • COPD symptom control 0(Baseline)
  • Anxiety and Depression 1(8 weeks)
  • Anxiety and Depression 2(7 months)
  • Health-Related Quality of Life 2(7 months)
  • Dyspnoea 2(7 months)
  • Dyspnoea 3(12 months)
  • Health-Related Quality of Life 0(Baseline)
  • Number of emergency department visits due to COPD exacerbation 0(Baseline)
  • Dyspnoea 1(8 weeks)
  • Number of emergency department visits due to COPD exacerbation 2(7 months)
  • COPD symptom control 3(12 months)
  • Functional capacity 0(Baseline)
  • Health-Related Quality of Life 3(12 months)
  • Anxiety and Depression 0(Baseline)
  • Anxiety and Depression 3(12 months)
  • Physical activity 0(Baseline)
  • Physical activity 2(7 months)
  • Number of emergency department visits due to COPD exacerbation 1(8 weeks)
  • COPD symptom control 1(8 weeks)
  • COPD symptom control 2(7 months)
  • Physical activity 1(8 weeks)
  • Physical activity 3(12 months)
  • Functional capacity 1(8 weeks)
  • Functional capacity 3(12 months)
  • Functional capacity 2(7 months)

Study Sites (1)

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