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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05315505
Other study ID # 136/CES/JAS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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