Clinical trial NCT04552652: High-intensity Interval Training and Telerehabilitation
Official title: Effect of Home-based High-Intensity Interval Training Using TeleRehabilitation Among Coronary Heart Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Cardiac rehabilitatiion
Telerehabilitation
High-intensity interval training
Cardiorespiratory fitness
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Telerehabilitation has the potential to become an alternative attitude to outpatient cardiac rehabilitation. The aim of our study is to research the method of high-intensity interval training in the home environment using telerehabilitation. Investigators assume that the high-intensity interval training form of telerehabilitation, using a heart rate monitor as a tool for backing up training data, can improve physical fitness and lead to higher peak oxygen uptake as the traditional moderate-intensity continuous training. The study is designed as a monocentral randomized controlled trial at University Hospital Brno in the Czech Republic.

After the coronary event, eligible patients will be randomly (in 1:1 ratio) separated into two groups: the experimental high-intensity interval training group and the moderate-intensity continuous control group. Both groups undergo a 12-week telerehabilitation training program with a 52-week follow-up period. The primary outcome observed will be the effect of intervention expressed by changes in peak oxygen uptake values.

Detailed description: The study relates to the previous study project CR-GPS, in which investigators proved the feasibility of cardiac telerehabilitation. The results showed that aerobic capacity and quality of life improved similarly in telerehabilitation and outpatient group of participating patients. During the research, investigators used the moderate-intensity continuous method. The present research focuses on high-intensity interval training, which presents comparable or even better results in cardiorespiratory condition effects and requires less time than a continuous method in patients with low or medium cardiovascular risk.

Eligibility criteria: Inclusion Criteria:

* Participants with coronary artery disease (in last two months)
* with low or medium cardiovascular risk
* with heart revascularization
* with recommended pharmacotherapy
* with clinically stable state
* with the ability to perform a cardiopulmonary exercise test
* with the ability to understand and write in the Czech language
* with an internet connection at home
* literacy with information and communication technology

Exclusion Criteria:

* Participants who were hospitalized with heart disease in the previous six weeks
* with psychological severe or cognitive disorders
* with contraindications for cardiopulmonary exercise testing
* with severe training limitations besides coronary artery disease
* with a planned intervention or operation
* participants who are enrolled in or participate in an outpatient form of cardiac rehabilitation
* participants who plan to be or are included in other studies

Primary outcomes:
measure: Cardiorepisratory fitness (CRF)
timeFrame: Change from baseline to 12 weeks and 52weeks
Secondary outcomes:
measure: Health-related quality of life (SF-36 Form)
timeFrame: Change from baseline to 12 weeks and 52weeks
measure: Hospital Anxiety and Depression scale (HADS)
timeFrame: Change from baseline to 12 weeks and 52weeks
measure: Satisfaction - self-completed questionnaire
timeFrame: 12 weeks and 52weeks
measure: Body composition (BIA)
timeFrame: Change from baseline to 12 weeks and 52weeks
measure: Incidence of treatment-emergent adverse events assessed by 5 grade scale
timeFrame: Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks.
measure: Training adherence (Number of compliant participants, Average exercise time, Overall completition rate)
timeFrame: 12 weeks
measure: Anxiety (General anxiety disorder, 7-item scale)
timeFrame: Change from baseline to 12 weeks and 52weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: University Hospital Brno, Czech Republic
name: Filip Dosbaba, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: