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

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ClinicalTrials.gov Identifier: NCT04658979
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
Fondation IUCPQ
Information provided by (Responsible Party):
Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.


Condition or disease Intervention/treatment Phase
Chronic Pulmonary Disease Other: Pulmonary tele-rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Feasibility and Safety of a Pulmonary Tele-rehabilitation Program in the Times of COVID-19
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group Other: Pulmonary tele-rehabilitation
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 Measures :
  1. Feasability - Patients´ satisfaction with the program between baseline and the up to 12 weeks follow-up [ Time Frame: 12 weeks ]
    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).

  2. Feasability - Health care professionals' receptivity [ Time Frame: 12 weeks ]
    Health care professionals' receptivity towards the tele-rehabilitation will be assess by 18 questions based on an 6-point scale (0 to 5).

  3. Feasibility - Patients' satisfaction with the health care received [ Time Frame: 12 weeks ]
    Patient's satisfaction will be evaluated by a questionnaire including 23 questions based on a 4-point scale (1 to 4).


Secondary Outcome Measures :
  1. Quality of life by questionnaire [ Time Frame: 12 weeks ]

    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)


  2. Dyspnea level [ Time Frame: 12 weeks ]
    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.

  3. Exercise capacity [ Time Frame: 12 weeks ]
    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

  4. Exercise capacity [ Time Frame: 12 weeks ]
    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.

  5. Functionnal capacity [ Time Frame: 12 weeks ]
    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.

  6. Functionnal capacity [ Time Frame: 12 weeks ]
    The functional capacity will be evaluated by the hand grip test before and after the program and measured in kilograms.

  7. Functionnal capacity [ Time Frame: 12 weeks ]
    The functional capacity will be evaluated by the maximum voluntary contraction force of the quadriceps before and after the program.

  8. Anxiety [ Time Frame: 12 weeks ]
    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)

  9. Depression [ Time Frame: 12 weeks ]
    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)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658979


Contacts
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Contact: Didier Saey, Ph.D 418-656-8711 ext 2614 didier.saey@criucpq.ulaval.ca
Contact: Jany Harvey, M.Sc. 418-656-8711 ext 5882 jany.harvey@criucpq.ulaval.ca

Locations
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Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec Recruiting
Québec, Quebec, Canada, G1V 4G5
Contact: Didier Saey, PhD    418-656-8711 ext 2614    didier.saey@criucpq.ulaval.ca   
Principal Investigator: Didier Saey, PhD         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Fondation IUCPQ
Investigators
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Principal Investigator: Didier Saey, Ph.D Institut universitaire de cardiologie et de pneumologie de Québec -ULaval
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Responsible Party: Didier Saey, Principal investigator, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT04658979    
Other Study ID Numbers: 21983
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
Pulmonary Telerehabilitation
Safety
Feasibility
Interstitial lung disease
Chronic obstructive lung disease
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases