NCT04658979

Brief Summary

Chronic pulmonary disease like interstitial lung disease (ILD) and chronic obstructive lung disease (COPD) are a significant health problem in Canada and around the world. In addition to the respiratory impairment resulting to a progressive dyspnea, these diseases are also characterized by a decrease in exercise tolerance and muscle dysfunction which affect the patient's quality of life. Respiratory rehabilitation is the cornerstone of the management of chronic disease and it includes a set of personalized care mainly delivered in person by a transdisciplinary team and with the objectives of reducing the symptoms felt by the participants and improving their physical and psychosocial condition. The current containment due to the COVID-19 pandemic increase the sedentary behavior of patients and prevents the holding of any respiratory rehabilitation activity. In this context, tele-rehabilitation appears to be a particularly well-suited solution because it would make it possible to offer a respiratory rehabilitation in a safe and effective manner while minimizing contact with the participants. Although some studies support the feasibility of this intervention, more data is needed to validate its routine clinical application. The main objective of this study is to verify the safety and the feasibility of delivering pulmonary rehabilitation treatments entirely at home via a telerehabilitation patform developed at the Institut universitraire de cardiologie et de pneumologie de Québec (IUCPQ), and document its effectiveness in people with chronic respiratory disease. The secondary objectives will be: 1) to explore the effects of a telerehabilitation programm on exercise tolerance, muscle function, functional capacity and quality of life, and 2) to assess the satisfaction of participants and health care providers with telerehabilitation.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 2, 2020

Last Update Submit

December 9, 2020

Conditions

Keywords

Pulmonary TelerehabilitationSafetyFeasibilityInterstitial lung diseaseChronic obstructive lung disease

Outcome Measures

Primary Outcomes (3)

  • Feasability - Patients´ satisfaction with the program between baseline and the up to 12 weeks follow-up

    Patient's satisfaction will be evaluated by a questionnaire including 7 questions on his feeling of competence with regard to the program, based on an 8-point Likert scale (0 to 7).

    12 weeks

  • Feasability - Health care professionals' receptivity

    Health care professionals' receptivity towards the tele-rehabilitation will be assess by 18 questions based on an 6-point scale (0 to 5).

    12 weeks

  • Feasibility - Patients' satisfaction with the health care received

    Patient's satisfaction will be evaluated by a questionnaire including 23 questions based on a 4-point scale (1 to 4).

    12 weeks

Secondary Outcomes (9)

  • Quality of life by questionnaire

    12 weeks

  • Dyspnea level

    12 weeks

  • Exercise capacity

    12 weeks

  • Exercise capacity

    12 weeks

  • Functionnal capacity

    12 weeks

  • +4 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL
Other: Pulmonary tele-rehabilitation

Interventions

All the participant will by include in a tele-rehabilitation program who will be based on an 12-week intervention including therapeutic education and self-management sessions and training sessions, delivered through a videoconferencing application. All interventions will be under the supervision of a rehabilitation professional from the Pavillon de prévention des maladies cardiovasculaire (PPMC) and modeled according to the recommendations of the ATS/ERS.

Intervention group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient already participate to the telerehabilitation program in the PPMC at IUCPQ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Lung Diseases, InterstitialPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Didier Saey, Ph.D

    Institut universitaire de cardiologie et de pneumologie de Québec -ULaval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 9, 2020

Study Start

December 1, 2020

Primary Completion

March 1, 2021

Study Completion

January 1, 2022

Last Updated

December 10, 2020

Record last verified: 2020-12

Locations