Chronic Pulmonary DiseaseTele-RehaBNCT04658979
Pulmonary TELE-REHABilitation Program : Feasibility and Safety Study
A study testing Pulmonary tele-rehabilitation in people with Chronic Pulmonary Disease, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Pulmonary Disease
- What is being tested?
- Pulmonary tele-rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2020to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient already participate to the telerehabilitation program in the PPMC at IUCPQ
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
Didier Saey, PhD, 418-656-8711 ext. 2614, didier.saey@criucpq.ulaval.ca
Didier Saey, PhD
About this study
Official title: Evaluation of the Feasibility and Safety of a Pulmonary Tele-rehabilitation Program in the Times of COVID-19
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.
- Conditions
- Chronic Pulmonary Disease
- Being tested
- Pulmonary tele-rehabilitation
- Keywords
- Pulmonary Telerehabilitation, Safety, Feasibility, Interstitial lung disease, Chronic obstructive lung disease
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary tele-rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Pulmonary tele-rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 12 weeks
Secondary outcomes (9)
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)
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Functionnal capacity
The functional capacity will be evaluated by the hand grip test before and after the program and measured in kilograms.
Measured: 12 weeks
Functionnal capacity
The functional capacity will be evaluated by the maximum voluntary contraction force of the quadriceps before and after the program.
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation IUCPQ
- Responsible party
- Principal investigator, Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Investigators
- Didier Saey, Ph.D, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec -ULaval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658979
- Sponsor's protocol ID
- 21983
- Acronym
- Tele-RehaB
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Safety of a Pulmonary Tele-rehabilitation Program in the Times of COVID-19
- ClinicalTrials.gov ID
- NCT04658979
- Acronym / sponsor ID
- Tele-RehaB / 21983
- Conditions
- Chronic Pulmonary Disease
- Keywords
- Pulmonary Telerehabilitation, Safety, Feasibility, Interstitial lung disease, Chronic obstructive lung disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Collaborators
- Fondation IUCPQ
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pulmonary tele-rehabilitation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patient already participate to the telerehabilitation program in the PPMC at IUCPQ
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary tele-rehabilitationAll 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. | Other | Intervention group |
Primary outcome
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).
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).
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).
9 secondary outcomes
Quality of life by questionnaire
Time frame: 12 weeks
Dyspnea level
Time frame: 12 weeks
Exercise capacity
Time frame: 12 weeks
Exercise capacity
Time frame: 12 weeks
Functionnal capacity
Time frame: 12 weeks
Functionnal capacity
Time frame: 12 weeks
Functionnal capacity
Time frame: 12 weeks
Anxiety
Time frame: 12 weeks
Depression
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Saey, Ph.D principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec -ULaval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary tele-rehabilitation in people with Chronic Pulmonary Disease, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Saey, Ph.D (418-656-8711 ext. 2614, didier.saey@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability - Patients´ satisfaction with the program between baseline and the up to 12 weeks follow-up (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.