High-intensity Interval Training and Telerehabilitation

NCT ID: NCT04552652

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-07-25

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High-intensity interval training - telerehabilitation

12 weeks of high-intensity interval training. Three sessions per week will be performed (36 total sessions).

Group Type: EXPERIMENTAL

High-Intensity Interval Training

Intervention Type: BEHAVIORAL

Remotely monitored exercises will be performed at home. The high-intensity interval group warms-up for 5 minutes at moderate intensity (65-75% of maximal heart rate). After warm-up exercise, will continue in 4 minutes intervals at high-intensity to reach the target zone (85-95% of maximal heart rate) Each interval will be separated by 3 minutes of active recoveries (at 65-75% of maximal heart rate). The session ends with a 3-minute cool-down phase. Overall training exercise time will be 33 minutes - isocaloric compared to moderate-intensity continous training group. All participants will train using a heart rate monitor during each workout.

Moderate-intensity continuous training - telerehabilitation

12 weeks of moderate-intensity continuous training. Three sessions per week will be performed (36 total sessions).

Group Type: ACTIVE_COMPARATOR

Moderate-intensity continuous training

Intervention Type: BEHAVIORAL

Remotely monitored exercises will be performed at home. Patients in the moderate-intensity continuous training group will perform a 41-minute constant workout with an intensity of 65-75% of maximum heart rate, representing the same total training load as the high-intensity aerobic exercise group. All participants will train using a heart rate monitor during each workout.

Interventions

High-Intensity Interval Training

Remotely monitored exercises will be performed at home. The high-intensity interval group warms-up for 5 minutes at moderate intensity (65-75% of maximal heart rate). After warm-up exercise, will continue in 4 minutes intervals at high-intensity to reach the target zone (85-95% of maximal heart rate) Each interval will be separated by 3 minutes of active recoveries (at 65-75% of maximal heart rate). The session ends with a 3-minute cool-down phase. Overall training exercise time will be 33 minutes - isocaloric compared to moderate-intensity continous training group. All participants will train using a heart rate monitor during each workout.

Intervention Type: BEHAVIORAL

Moderate-intensity continuous training

Remotely monitored exercises will be performed at home. Patients in the moderate-intensity continuous training group will perform a 41-minute constant workout with an intensity of 65-75% of maximum heart rate, representing the same total training load as the high-intensity aerobic exercise group. All participants will train using a heart rate monitor during each workout.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ladislav Batalik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip Dosbaba, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno, Czech Republic

Locations

University Hospital Brno

Brno, , Czechia

Countries

Czechia

Other Identifiers

RHO58/20

Identifier Type: -

Identifier Source: org_study_id