Cardiac DiseaseNCT05749744
Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.
An observational study of Cardiac Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
After an acute coronary syndrome, an adapted cardiac rehabilitation program is necessary to restore or increase physical capacities and decrease cardiovascular risk. This multidisciplinary care combines physical training sessions and therapeutic education workshops. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- cardiac telerehabilitation program by videoconference
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient Acute Coronary Syndrome treated in the last 6 months will be included.
Who may be able to join
- Both groups:
- Acute Coronary Syndrome treated in the last 6 months
- Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
- For Telerehabilitation group:
- Internet connexion (computer or digital tablet)
- Equipped with an exercise bike
Who cannot join
- Both groups:
- Pulmonary hypertension
- Aortic pathway anomaly
- Uncontrolled ventricular rhythm disorders
- For Telerehabilitation group:
- Important muscular deconditioning
- Patient requiring medical supervision in institute
Trial locations and contacts
1 site in 1 country.
About this study
After an acute coronary syndrome, an adapted cardiac rehabilitation program is necessary to restore or increase physical capacities and decrease cardiovascular risk. This multidisciplinary care combines physical training sessions and therapeutic education workshops.
The COVID-19 pandemic imposed restrictions such as the closure of rehabilitation centres. To remedy this problem, one solution was to adapt the existing program to a remote cardiac telerehabilitation, i.e., medical and paramedical supervision of rehabilitation sessions and therapeutic patient education meetings via digital tools. Recent studies have shown that it was a safe (no reported adverse effects), effective (similar gains in peak oxygen consumption compared to traditional cardiac rehabilitation and patient-adherence alternative.
Read the detailed description
The hypothesis of this study is that telerehabilitation was more effective on cardiorespiratory functions.
- Conditions
- Cardiac Disease
- Being tested
- cardiac telerehabilitation program by videoconference
- Keywords
- cardiac telerehabilitation, acute coronary syndrome, rehabilitation therapeutic, rehabilitation sessions, cardiorespiratory functions
- Medical subject headings
- Heart Diseases, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac telerehabilitation program by videoconferenceOther
- A video conference interview with an Adapted Physical Activity (APA) teacher before starting physical training
- Exercise training for 3 weeks via distance coaching
- Therapeutic patient education (TPE) workshops conducted remotely with 1 workshop per week.
- Medical follow-up via teleconsultation
- Psychological and/or dietetic follow-up if necessary.
- Final assessment at 1 month with evaluation of aerobic metabolism, functional evaluation and final shared educational assessment (BEP).
- Appointment with an association "Cœur et Santé" and "Sport-Santé 42" or setting up of an individual physical activity
| Study group | Role | What they receive |
|---|---|---|
| Home-based cardiac telerehabilitation (interventional group) | Patients followed the cardiac rehabilitation program at home. Receives: Other: cardiac telerehabilitation program by videoconference | |
| Traditional centre-based cardiac rehabilitation (control group) | Patients participates in the cardiac rehabilitation program in hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) at 2 months
Variation of oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) during a cardio-pulmonary exercise test (CPET) before and after 15 training sessions performed
Measured: Months: 0, 2
Secondary outcomes (9)
oxygen (VO2) peak
Variation of oxygen (VO2) peak before and after 15 training sessions performed
Measured: Months: 0, 2
maximum power workload
Variation of maximum power workload before and after 15 training sessions performed
Measured: Months: 0, 2
power at the first ventilatory threshold (VT1)
Variation of power at the first ventilatory threshold (VT1) before and after 15 training sessions performed
Measured: Months: 0, 2
maximum heart rate
Variation of maximum heart rate before and after 15 training sessions performed.
Measured: Months: 0, 2
recovery heart rate
Variation of recovery heart rate before and after 15 training sessions performed.
Measured: Months: 0, 2
obstructive ventilatory disorder
Variation of obstructive ventilatory disorder before and after 15 training sessions performed.
Measured: Months: 0, 2
autonomic nervous system
Variation of autonomic nervous system before and after 15 training sessions performed.
Measured: Months: 0, 2
muscular strength
Variation of muscular strength before and after 15 training sessions performed.
Measured: Months: 0, 2
muscular endurance
Variation of muscular endurance before and after 15 training sessions performed.
Measured: Months: 0, 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Mar 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hupin, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749744
- Sponsor's protocol ID
- IRBN1022021/CHUSTE
- Status last verified
- Dec 2021
- First submitted
- 27 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiac Telerehabilitation During COVID-19 on Cardiorespiratory Capacities in Coronary Artery Disease Patients.
- ClinicalTrials.gov ID
- NCT05749744
- Acronym / sponsor ID
- IRBN1022021/CHUSTE
- Conditions
- Cardiac Disease
- Keywords
- cardiac telerehabilitation, acute coronary syndrome, rehabilitation therapeutic, rehabilitation sessions, cardiorespiratory functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Mar 2023 (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.
After an acute coronary syndrome, an adapted cardiac rehabilitation program is necessary to restore or increase physical capacities and decrease cardiovascular risk. This multidisciplinary care combines physical training sessions and therapeutic education workshops.
The COVID-19 pandemic imposed restrictions such as the closure of rehabilitation centres. To remedy this problem, one solution was to adapt the existing program to a remote cardiac telerehabilitation, i.e., medical and paramedical supervision of rehabilitation sessions and therapeutic patient education meetings via digital tools. Recent studies have shown that it was a safe (no reported adverse effects), effective (similar gains in peak oxygen consumption compared to traditional cardiac rehabilitation and patient-adherence alternative.
Detailed description
The hypothesis of this study is that telerehabilitation was more effective on cardiorespiratory functions.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based cardiac telerehabilitation (interventional group) | – | Other: cardiac telerehabilitation program by videoconferencePatients followed the cardiac rehabilitation program at home. |
| Traditional centre-based cardiac rehabilitation (control group) | – | –Patients participates in the cardiac rehabilitation program in hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient Acute Coronary Syndrome treated in the last 6 months will be included.
Key inclusion criteria (6 listed)
- Acute Coronary Syndrome treated in the last 6 months
- Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
- Internet connexion (computer or digital tablet)
- Equipped with an exercise bike
Key exclusion criteria (7 listed)
- Pulmonary hypertension
- Aortic pathway anomaly
- Uncontrolled ventricular rhythm disorders
- Important muscular deconditioning
- Patient requiring medical supervision in institute
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 |
|---|---|---|
| cardiac telerehabilitation program by videoconference* A video conference interview with an Adapted Physical Activity (APA) teacher before starting physical training * Exercise training for 3 weeks via distance coaching * Therapeutic patient education (TPE) workshops conducted remotely with 1 workshop per week. * Medical follow-up via teleconsultation * Psychological and/or dietetic follow-up if necessary. * Final assessment at 1 month with evaluation of aerobic metabolism, functional evaluation and final shared educational assessment (BEP). * Appointment with an association "Cœur et Santé" and "Sport-Santé 42" or setting up of an individual physical activity | Other | Home-based cardiac telerehabilitation (interventional group) |
Primary outcome
Change from Baseline oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) at 2 months
Time frame: Months: 0, 2
Variation of oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) during a cardio-pulmonary exercise test (CPET) before and after 15 training sessions performed
9 secondary outcomes
oxygen (VO2) peak
Time frame: Months: 0, 2
maximum power workload
Time frame: Months: 0, 2
power at the first ventilatory threshold (VT1)
Time frame: Months: 0, 2
maximum heart rate
Time frame: Months: 0, 2
recovery heart rate
Time frame: Months: 0, 2
obstructive ventilatory disorder
Time frame: Months: 0, 2
autonomic nervous system
Time frame: Months: 0, 2
muscular strength
Time frame: Months: 0, 2
muscular endurance
Time frame: Months: 0, 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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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.
David Hupin, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 3 Mar 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline oxygen (VO2) (ml/min/kg) at the first ventilatory threshold (VT1) at 2 months (time frame: Months: 0, 2). 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 3 Mar 2023.