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

NCT ID: NCT05315505

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome evaluation will be performed by a cardiopulmonary technician that has no information about the patient group

Study Groups

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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

Group Type EXPERIMENTAL

Maintenance programme

Intervention Type OTHER

Continuous educational support, exercise training, behaviour change intervention, and self-management.

Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Usual Care

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

Intervention Type OTHER

Other Intervention Names

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Physical exercise Behaviour change Self-management

Eligibility Criteria

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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;
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unidade Local de Saúde de Matosinhos, EPE

OTHER

Sponsor Role lead

Responsible Party

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Liliana Silva

RN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liliana Silva, MSc

Role: PRINCIPAL_INVESTIGATOR

Matosinhos Local Health Unit

Locations

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Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Porto District, Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Liliana Silva, MSc

Role: CONTACT

+351917556931

Miguel Padilha, PhD

Role: CONTACT

Facility Contacts

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Liliana Silva, MSc

Role: primary

+351917556931

Liliana Silva, MSc

Role: backup

References

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Silva L, Maricoto T, Mota A, Lemos L, Santos M, Cunha H, Azevedo I, Berger-Estilita J, Costa P, Padilha JM. Effectiveness of a home-based pulmonary rehabilitation maintenance programme: the Rehab2Life study protocol. BMC Nurs. 2024 May 21;23(1):338. doi: 10.1186/s12912-024-01999-6.

Reference Type DERIVED
PMID: 38773568 (View on PubMed)

Other Identifiers

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136/CES/JAS

Identifier Type: -

Identifier Source: org_study_id

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