Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients (Rehab2life)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation
• Intervention / Treatment: Other: Maintenance programme; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liliana Silva, MSc; Phone Number: +351917556931; Email: enf.lilianasilva@gmail.com
• Study Contact Backup: Name: Miguel Padilha, PhD; Email: miguelpadilha@esenf.pt

Study Locations

• Portugal
  • Porto
    • Matosinhos, Porto, Portugal, 4450
      • Recruiting
      • Unidade Local de Saúde de Matosinhos
      • Contact: Liliana Silva, MSc; Phone Number: +351917556931; Email: enf.lilianasilva@gmail.com
      • Contact: Liliana Silva, MSc; Email: liliana.silva@ulsm.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maintenance; 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; Continuous educational support, exercise training, behaviour change intervention, and self-management. Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision; Other Names: Physical exercise; Behaviour change; Self-management
Active Comparator: control; 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; No maintenance programme, and the patient has the usual follow-up and medical appointments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unidade Local de Saúde de Matosinhos, EPE
• Investigators: Principal Investigator: Liliana Silva, MSc, Matosinhos Local Health Unit

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COPD; Pulmonary rehabilitation; Maintenance pulmonary rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 136/CES/JAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No