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Pulmonary TELE-REHABilitation Program : Feasibility and Safety Study

Evaluation of the Feasibility and Safety of a Pulmonary Tele-rehabilitation Program in the Times of COVID-19

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04658979
Acronym
Tele-RehaB
Enrollment
30
Registered
2020-12-09
Start date
2020-12-31
Completion date
2022-01-31
Last updated
2020-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pulmonary Disease

Keywords

Pulmonary Telerehabilitation, Safety, Feasibility, Interstitial lung disease, Chronic obstructive lung disease

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.

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.

Sponsors

Fondation IUCPQ
CollaboratorOTHER
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Feasability - Patients´ satisfaction with the program between baseline and the up to 12 weeks follow-up12 weeksPatient'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' receptivity12 weeksHealth 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 received12 weeksPatient's satisfaction will be evaluated by a questionnaire including 23 questions based on a 4-point scale (1 to 4).

Secondary

MeasureTime frameDescription
Exercise capacity12 weeksThe 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
Functionnal capacity12 weeksThe 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.
Depression12 weeksThe 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)
Anxiety12 weeksThe 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)
Quality of life by questionnaire12 weeksFor 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 level12 weeksThe 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.

Countries

Canada

Contacts

Primary ContactDidier Saey, Ph.D
didier.saey@criucpq.ulaval.ca418-656-8711
Backup ContactJany Harvey, M.Sc.
jany.harvey@criucpq.ulaval.ca418-656-8711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026