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Pulmonary TELE-REHABilitation Program : Feasibility and Safety Study (Tele-RehaB)

Primary Purpose

Chronic Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pulmonary tele-rehabilitation
Sponsored by
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pulmonary Disease focused on measuring Pulmonary Telerehabilitation, Safety, Feasibility, Interstitial lung disease, Chronic obstructive lung disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de QuébecRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

Quality of life by questionnaire
For the COPD participants the quality of live will be evaluated with the COPD Assessment test (CAT) and fort he ILD participants with the Kings' Brief Interstitial Lung Disease (K-BLID) questionnaire. CAT = K-BLID = 15 questions rate between 1 to 7 (maximal score = 105 = better quality of life; minimal score = 15 = worse quality of life)
Dyspnea level
The dyspnea level will be evaluated with the MRC questionnaire = 4 questions If the patient answer yes to the first question he continue to the next question, if he answer no the questionnaire is finish. The further he goes in the questionnaire, worse the breathlessness score is.
Exercise capacity
The exercise capacity will be evaluated by the 6-minutes stepper test before and after the program, the result will be the number of cycle complet
Exercise capacity
The exercise capacity will be evaluated by the 1-minute sit to stand test before and after the program, the result will be the number of complet sit to stand.
Functionnal capacity
The functional capacity will be evaluated by the Short Physical Performance Battery test (SPPB) test before and after the program, the result will be the total on 12.
Functionnal capacity
The functional capacity will be evaluated by the hand grip test before and after the program and measured in kilograms.
Functionnal capacity
The functional capacity will be evaluated by the maximum voluntary contraction force of the quadriceps before and after the program.
Anxiety
The anxiety will be assess by the Hospital Anxiety and Depression scale (HAD). Total of 14 questions (maximal score = 42 = worse; minimal score = 0= better) where 7 questions is for the anxiety score(maximal score = 21 = worse; minimal score = 0= better)
Depression
The depression will by assess by Hospital Anxiety and Depression scale.14 questions (maximal score = 42 = worse; minimal score = 0= better) where 7 questions is for the depression score (maximal score = 21 = worse; minimal score = 0= better)

Full Information

First Posted
December 2, 2020
Last Updated
December 9, 2020
Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborators
Fondation IUCPQ
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1. Study Identification

Unique Protocol Identification Number
NCT04658979
Brief Title
Pulmonary TELE-REHABilitation Program : Feasibility and Safety Study
Acronym
Tele-RehaB
Official Title
Evaluation of the Feasibility and Safety of a Pulmonary Tele-rehabilitation Program in the Times of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborators
Fondation IUCPQ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pulmonary Disease
Keywords
Pulmonary Telerehabilitation, Safety, Feasibility, Interstitial lung disease, Chronic obstructive lung disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pulmonary tele-rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasability - Patients´ satisfaction with the program between baseline and the up to 12 weeks follow-up
Description
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).
Time Frame
12 weeks
Title
Feasability - Health care professionals' receptivity
Description
Health care professionals' receptivity towards the tele-rehabilitation will be assess by 18 questions based on an 6-point scale (0 to 5).
Time Frame
12 weeks
Title
Feasibility - Patients' satisfaction with the health care received
Description
Patient's satisfaction will be evaluated by a questionnaire including 23 questions based on a 4-point scale (1 to 4).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of life by questionnaire
Description
For the COPD participants the quality of live will be evaluated with the COPD Assessment test (CAT) and fort he ILD participants with the Kings' Brief Interstitial Lung Disease (K-BLID) questionnaire. CAT = K-BLID = 15 questions rate between 1 to 7 (maximal score = 105 = better quality of life; minimal score = 15 = worse quality of life)
Time Frame
12 weeks
Title
Dyspnea level
Description
The dyspnea level will be evaluated with the MRC questionnaire = 4 questions If the patient answer yes to the first question he continue to the next question, if he answer no the questionnaire is finish. The further he goes in the questionnaire, worse the breathlessness score is.
Time Frame
12 weeks
Title
Exercise capacity
Description
The exercise capacity will be evaluated by the 6-minutes stepper test before and after the program, the result will be the number of cycle complet
Time Frame
12 weeks
Title
Exercise capacity
Description
The exercise capacity will be evaluated by the 1-minute sit to stand test before and after the program, the result will be the number of complet sit to stand.
Time Frame
12 weeks
Title
Functionnal capacity
Description
The functional capacity will be evaluated by the Short Physical Performance Battery test (SPPB) test before and after the program, the result will be the total on 12.
Time Frame
12 weeks
Title
Functionnal capacity
Description
The functional capacity will be evaluated by the hand grip test before and after the program and measured in kilograms.
Time Frame
12 weeks
Title
Functionnal capacity
Description
The functional capacity will be evaluated by the maximum voluntary contraction force of the quadriceps before and after the program.
Time Frame
12 weeks
Title
Anxiety
Description
The anxiety will be assess by the Hospital Anxiety and Depression scale (HAD). Total of 14 questions (maximal score = 42 = worse; minimal score = 0= better) where 7 questions is for the anxiety score(maximal score = 21 = worse; minimal score = 0= better)
Time Frame
12 weeks
Title
Depression
Description
The depression will by assess by Hospital Anxiety and Depression scale.14 questions (maximal score = 42 = worse; minimal score = 0= better) where 7 questions is for the depression score (maximal score = 21 = worse; minimal score = 0= better)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient already participate to the telerehabilitation program in the PPMC at IUCPQ
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Didier Saey, Ph.D
Phone
418-656-8711
Ext
2614
Email
didier.saey@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jany Harvey, M.Sc.
Phone
418-656-8711
Ext
5882
Email
jany.harvey@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Saey, Ph.D
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec -ULaval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Saey, PhD
Phone
418-656-8711
Ext
2614
Email
didier.saey@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Didier Saey, PhD

12. IPD Sharing Statement

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Pulmonary TELE-REHABilitation Program : Feasibility and Safety Study

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