NCT04284865

Brief Summary

Pulmonary rehabilitation (PR) has been shown to improve quality of life of people with COPD by decreasing their symptoms. However, the benefits obtained during PR tend to decrease within six months to one year after PR. The objective of this study is to implement a web platform following PR programs in order to improve COPD patients' adherence to self-management techniques. Therefore, the investigators want to verify whether the addition of a tele-management tool allows the gains obtained during PR to be retained over 3, 6 and 12 months. The hypothesis is that participants will maintain their PR gains if they use the platform.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

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

February 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 14, 2025

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

February 20, 2020

Last Update Submit

January 10, 2025

Conditions

COPD

Keywords

Self-managementLong-term careTelehealth

Outcome Measures

Primary Outcomes (4)

  • Change in Adherence of each participant

    The number of connections made on the site

    3 months, 6 months and 12 months

  • Change in Adherence of each participant

    the number of exercises performed on the platform web

    3 months, 6 months and 12 months

  • Change in Adherence of each participant

    Number of entry/week in the logbook on the platform web

    3 months, 6 months and 12 months

  • Change in Adherence of each participant

    the number of exercises performed (breathing, cardiorespiratory and muscular exercises) self-reported by the participants

    3 months, 6 months and 12 months

Secondary Outcomes (5)

  • Change in Exercise capacity

    pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months

  • Change of the Quality of life

    pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months

  • Change in dyspnea

    pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months

  • Change of Number of hospitalizations

    pre-pulmonary rehabilitation, 0 months, 6 months and 12 months

  • Change of Number of exacerbations

    pre-pulmonary rehabilitation, 0 months, 6 months and 12 months

Study Arms (1)

Intervention group

EXPERIMENTAL

The web platform includes three respiratory exercises: diaphragmatic breathing, thoracic expansion exercise and thoracic expansion exercise assisted upper limbs. It is suggested to do each of the three exercises once a day (AM and PM), four repetitions each. An electronic logbook is also available on the platform to record the duration and the type of others cardiorespiratory exercise of their choice (cycling, walking, using stairs, etc.) as well as strengthening (upper and lower body).

Other: Web Platform

Interventions

Web PlatformOTHER

The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Complete the PR program at CIUSSSS of Estrie-CHUS in Sherbrooke and finishing after December 2019
  • To have a mild to very severe diagnosis of COPD (mild: forced expiratory volume in 1 second (FEV1) ) ≥ 80%, very severe: FEV1 \<30% and Tiffeneau score \<0.7)
  • Have a score ≥2 on the Medical Research Council (MRC) dyspnea scale
  • Have access to a computer, laptop or cell phone at home with an high speed internet service.

You may not qualify if:

  • Inability to give informed consent
  • Instable condition in the 4 weeks prior to the study (change in medication and symptoms such as dyspnea and sputum (colour and quantity)).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

    PMID: 33511633DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
adjunct professor

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 26, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 31, 2021

Last Updated

January 14, 2025

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)