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

Chronic Obstructive Pulmonary Disease Clinical Trial

— Rehab2life  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315505
• Other study ID #: 136/CES/JAS
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: April 2024

Study information

• Verified date: August 2023
• Source: Unidade Local de Saúde de Matosinhos, EPE
• Contact: Liliana Silva, MSc
• Phone: +351917556931
• Email: enf.lilianasilva[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

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
• Usual Care
No maintenance programme, and the patient has the usual follow-up and medical appointments

Locations

Country	Name	City	State
Portugal	Unidade Local de Saúde de Matosinhos	Matosinhos	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Unidade Local de Saúde de Matosinhos, EPE

Country where clinical trial is conducted

Portugal, 

Outcome

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