NCT05315505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2022

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

March 21, 2022

Last Update Submit

August 21, 2023

Conditions

Chronic Obstructive Pulmonary DiseasePulmonary Rehabilitation

Keywords

COPDPulmonary rehabilitationMaintenance pulmonary rehabilitation

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (28)

  • Dyspnoea 0

    Baseline

  • Dyspnoea 1

    8 weeks

  • Dyspnoea 2

    7 months

  • Dyspnoea 3

    12 months

  • Health-Related Quality of Life 0

    Baseline

  • +23 more secondary outcomes

Study Arms (2)

Maintenance

EXPERIMENTAL

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

Other: Maintenance programme

control

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Maintenance programmeOTHER

Continuous educational support, exercise training, behaviour change intervention, and self-management. Maintenance home-based pulmonary rehabilitation programme for ten months with alternate supervision

Also known as: Physical exercise, Behaviour change, Self-management
Maintenance
Usual CareOTHER

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

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Porto District, 4450, Portugal

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38773568DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

ExerciseSelf-Management

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Liliana Silva, MSc

    Matosinhos Local Health Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liliana Silva, MSc

CONTACT

+351917556931enf.lilianasilva@gmail.com

Miguel Padilha, PhD

CONTACT

miguelpadilha@esenf.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome evaluation will be performed by a cardiopulmonary technician that has no information about the patient group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 7, 2022

Study Start

May 9, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)