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High-intensity Interval Training and Telerehabilitation (HIIT-TR)

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
High-Intensity Interval Training
Moderate-intensity continuous training
Sponsored by
Brno University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Cardiac rehabilitatiion, Telerehabilitation, High-intensity interval training, Cardiorespiratory fitness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Brno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity interval training - telerehabilitation

Moderate-intensity continuous training - telerehabilitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cardiorepisratory fitness (CRF)
Peak oxygen uptake (VO2peak) during cardiopulmonary exercise test

Secondary Outcome Measures

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.
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.
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").
Body composition (BIA)
Total muscle mass, fat mass and body water will be measured by bioelectrical impedance analysis.
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.
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)
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.

Full Information

First Posted
September 11, 2020
Last Updated
July 25, 2023
Sponsor
Brno University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04552652
Brief Title
High-intensity Interval Training and Telerehabilitation
Acronym
HIIT-TR
Official Title
Effect of Home-based High-Intensity Interval Training Using TeleRehabilitation Among Coronary Heart Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
covid-19 pandemic complications with participants recruitment
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Cardiac rehabilitatiion, Telerehabilitation, High-intensity interval training, Cardiorespiratory fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training - telerehabilitation
Arm Type
Experimental
Arm Description
12 weeks of high-intensity interval training. Three sessions per week will be performed (36 total sessions).
Arm Title
Moderate-intensity continuous training - telerehabilitation
Arm Type
Active Comparator
Arm Description
12 weeks of moderate-intensity continuous training. Three sessions per week will be performed (36 total sessions).
Intervention Type
Behavioral
Intervention Name(s)
High-Intensity Interval Training
Intervention Description
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
Intervention Name(s)
Moderate-intensity continuous training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorepisratory fitness (CRF)
Description
Peak oxygen uptake (VO2peak) during cardiopulmonary exercise test
Time Frame
Change from baseline to 12 weeks and 52weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life (SF-36 Form)
Description
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.
Time Frame
Change from baseline to 12 weeks and 52weeks
Title
Hospital Anxiety and Depression scale (HADS)
Description
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.
Time Frame
Change from baseline to 12 weeks and 52weeks
Title
Satisfaction - self-completed questionnaire
Description
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").
Time Frame
12 weeks and 52weeks
Title
Body composition (BIA)
Description
Total muscle mass, fat mass and body water will be measured by bioelectrical impedance analysis.
Time Frame
Change from baseline to 12 weeks and 52weeks
Title
Incidence of treatment-emergent adverse events assessed by 5 grade scale
Description
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.
Time Frame
Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks.
Title
Training adherence (Number of compliant participants, Average exercise time, Overall completition rate)
Description
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)
Time Frame
12 weeks
Title
Anxiety (General anxiety disorder, 7-item scale)
Description
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.
Time Frame
Change from baseline to 12 weeks and 52weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Dosbaba, PT, PhD
Organizational Affiliation
University Hospital Brno, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
there is a plan to make the data on each participant available to other researchers through a web-based data register
IPD Sharing Time Frame
2020 - 2024
IPD Sharing Access Criteria
unlimited, open access

Learn more about this trial

High-intensity Interval Training and Telerehabilitation

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