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

U

Unidade Local de Saúde de Matosinhos, EPE

Status

Enrolling

Conditions

Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation

Treatments

Other: Usual Care
Other: Maintenance programme

Study type

Interventional

Funder types

Other

Identifiers

NCT05315505
136/CES/JAS

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 2 patient groups

Maintenance
Experimental group
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
Treatment:
Other: Maintenance programme
control
Active Comparator group
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.
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Central trial contact

Liliana Silva, MSc; Miguel Padilha, PhD

Data sourced from clinicaltrials.gov

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