High-intensity Interval Training and Telerehabilitation

Coronary Artery Disease Clinical Trial

— HIIT-TR  

Official title:

Effect of Home-based High-Intensity Interval Training Using TeleRehabilitation Among Coronary Heart Disease Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04552652
• Other study ID #: RHO58/20
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 25, 2023

Study information

• Verified date: July 2023
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorepisratory fitness (CRF)	Peak oxygen uptake (VO2peak) during cardiopulmonary exercise test	Change from baseline to 12 weeks and 52weeks
Secondary	Health-related quality of life (SF-36 Form)	The SF-36 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.	Change from baseline to 12 weeks and 52weeks
Secondary	Hospital Anxiety and Depression scale (HADS)	The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	Change from baseline to 12 weeks and 52weeks
Secondary	Satisfaction - self-completed questionnaire	Subjects will be provided with a 5-item self-completed questionnaire developed by our research team that will measure their satisfaction with the intervention they received and the study in general. The items will be presented in the form of statements to which subjects will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").	12 weeks and 52weeks
Secondary	Body composition (BIA)	Total muscle mass, fat mass and body water will be measured by bioelectrical impedance analysis.	Change from baseline to 12 weeks and 52weeks
Secondary	Incidence of treatment-emergent adverse events assessed by 5 grade scale	Participants will be encouraged to use the contact details for reporting incidence of treatment-emergent adverse events at any time throughout the study period.; The type, incidence, and severity of adverse events by scale (Grade 1: Mild, asymptomatic or mild symptoms; Grade 2: Moderate, minimal; Grade 3: Severe or medically significant; Grade 4: Life-threatening consequences; and Grade 5: Death) will be noted.	Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks.
Secondary	Training adherence (Number of compliant participants, Average exercise time, Overall completition rate)	Adherence to the training will be recorded in the exercise datasheets from the telemonitoring platform.; Evaluation of: the overall completion rate of prescribed exercise lessons (100% = 36); the total average time of all exercises in the defined heart rate zone; the total number of compliant participants (The criterium of compliance with the rehabilitation program is set at 70% of the prescribed training lessons)	12 weeks
Secondary	Anxiety (General anxiety disorder, 7-item scale)	Monitoring efficacy by score on a seven-item scale of generalized anxiety disorder. General anxiety disorder, 7-item scale total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.	Change from baseline to 12 weeks and 52weeks