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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Maintenance programme
Usual Care
Sponsored by
Unidade Local de Saúde de Matosinhos, EPE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Pulmonary rehabilitation, Maintenance pulmonary rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD diagnose with B, C ou D characterization according to GOLD criteria;
  • Residence in the area covered by the institution where the study is carried out

Exclusion Criteria:

  • COPD exacerbation for less than 1 week;
  • Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute exclusion criteria);
  • Presence of comorbidities that constitute relative exclusion criteria, thorough a medical evaluation.

Sites / Locations

  • Unidade Local de Saúde de MatosinhosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maintenance

control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Dyspnoea 0
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Dyspnoea 1
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Dyspnoea 2
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Dyspnoea 3
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
European quality of life-5 dimensions (EQ5D)
Health-Related Quality of Life 1
European quality of life-5 dimensions (EQ5D)
Health-Related Quality of Life 2
European quality of life-5 dimensions (EQ5D)
Health-Related Quality of Life 3
European quality of life-5 dimensions (EQ5D)
Number of emergency department visits due to COPD exacerbation 0
Number of exacerbations (accessing to emergency department)
Number of emergency department visits due to COPD exacerbation 1
Number of exacerbations (accessing to emergency department)
Number of emergency department visits due to COPD exacerbation 2
Number of exacerbations (accessing to emergency department)
Number of emergency department visits due to COPD exacerbation 3
Number of exacerbations (accessing to emergency department)
COPD symptom control 0
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
COPD symptom control 1
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
COPD symptom control 2
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
COPD symptom control 3
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
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
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
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
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
Physical activity 0
Counting steps per day with the pedometer Yamax EX510
Physical activity 1
Counting steps per day with the pedometer Yamax EX510
Physical activity 2
Counting steps per day with the pedometer Yamax EX510
Physical activity 3
Counting steps per day with the pedometer Yamax EX510
Functional capacity 0
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Functional capacity 1
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Functional capacity 2
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Functional capacity 3
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height

Full Information

First Posted
March 21, 2022
Last Updated
August 21, 2023
Sponsor
Unidade Local de Saúde de Matosinhos, EPE
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1. Study Identification

Unique Protocol Identification Number
NCT05315505
Brief Title
Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
Acronym
Rehab2life
Official Title
Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unidade Local de Saúde de Matosinhos, EPE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Keywords
COPD, Pulmonary rehabilitation, Maintenance pulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The outcome evaluation will be performed by a cardiopulmonary technician that has no information about the patient group
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maintenance
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Maintenance programme
Other Intervention Name(s)
Physical exercise, Behaviour change, Self-management
Intervention Description
Continuous educational support, exercise training, behaviour change intervention, and self-management. Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
No maintenance programme, and the patient has the usual follow-up and medical appointments
Primary Outcome Measure Information:
Title
Distance in meters covered over a time of 6 minutes 0
Description
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
Title
Distance in meters covered over a time of 6 minutes 1
Description
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
Title
Distance in meters covered over a time of 6 minutes 2
Description
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
Title
Distance in meters covered over a time of 6 minutes 3
Description
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
Secondary Outcome Measure Information:
Title
Dyspnoea 0
Description
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time Frame
Baseline
Title
Dyspnoea 1
Description
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time Frame
8 weeks
Title
Dyspnoea 2
Description
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time Frame
7 months
Title
Dyspnoea 3
Description
modified Medical Research Council dyspnoea scale (mMRC) - Range from 1 to 5, The higher the score, the worst the dyspnoea
Time Frame
12 months
Title
Health-Related Quality of Life 0
Description
European quality of life-5 dimensions (EQ5D)
Time Frame
Baseline
Title
Health-Related Quality of Life 1
Description
European quality of life-5 dimensions (EQ5D)
Time Frame
8 weeks
Title
Health-Related Quality of Life 2
Description
European quality of life-5 dimensions (EQ5D)
Time Frame
7 months
Title
Health-Related Quality of Life 3
Description
European quality of life-5 dimensions (EQ5D)
Time Frame
12 months
Title
Number of emergency department visits due to COPD exacerbation 0
Description
Number of exacerbations (accessing to emergency department)
Time Frame
Baseline
Title
Number of emergency department visits due to COPD exacerbation 1
Description
Number of exacerbations (accessing to emergency department)
Time Frame
8 weeks
Title
Number of emergency department visits due to COPD exacerbation 2
Description
Number of exacerbations (accessing to emergency department)
Time Frame
7 months
Title
Number of emergency department visits due to COPD exacerbation 3
Description
Number of exacerbations (accessing to emergency department)
Time Frame
12 months
Title
COPD symptom control 0
Description
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time Frame
Baseline
Title
COPD symptom control 1
Description
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time Frame
8 weeks
Title
COPD symptom control 2
Description
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time Frame
7 months
Title
COPD symptom control 3
Description
COPD Assessment Test - Range from 0 to 40. The higher the score, the worst the clinical control
Time Frame
12 months
Title
Anxiety and Depression 0
Description
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
Title
Anxiety and Depression 1
Description
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
Title
Anxiety and Depression 2
Description
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
Title
Anxiety and Depression 3
Description
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
Title
Physical activity 0
Description
Counting steps per day with the pedometer Yamax EX510
Time Frame
Baseline
Title
Physical activity 1
Description
Counting steps per day with the pedometer Yamax EX510
Time Frame
8 weeks
Title
Physical activity 2
Description
Counting steps per day with the pedometer Yamax EX510
Time Frame
7 months
Title
Physical activity 3
Description
Counting steps per day with the pedometer Yamax EX510
Time Frame
12 months
Title
Functional capacity 0
Description
Number of times per minute an individual is able to stand up and sit down on a chair standardised for height
Time Frame
Baseline
Title
Functional capacity 1
Description
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
Title
Functional capacity 2
Description
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
Title
Functional capacity 3
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liliana Silva, MSc
Phone
+351917556931
Email
enf.lilianasilva@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Padilha, PhD
Email
miguelpadilha@esenf.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liliana Silva, MSc
Organizational Affiliation
Matosinhos Local Health Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidade Local de Saúde de Matosinhos
City
Matosinhos
State/Province
Porto
ZIP/Postal Code
4450
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Silva, MSc
Phone
+351917556931
Email
enf.lilianasilva@gmail.com
First Name & Middle Initial & Last Name & Degree
Liliana Silva, MSc
Email
liliana.silva@ulsm.min-saude.pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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