NCT04552652

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

September 11, 2020

Last Update Submit

July 25, 2023

Conditions

Coronary Artery Disease

Keywords

Cardiac rehabilitatiionTelerehabilitationHigh-intensity interval trainingCardiorespiratory fitness

Outcome Measures

Primary Outcomes (1)

  • Cardiorepisratory fitness (CRF)

    Peak oxygen uptake (VO2peak) during cardiopulmonary exercise test

    Change from baseline to 12 weeks and 52weeks

Secondary Outcomes (7)

  • Health-related quality of life (SF-36 Form)

    Change from baseline to 12 weeks and 52weeks

  • Hospital Anxiety and Depression scale (HADS)

    Change from baseline to 12 weeks and 52weeks

  • Satisfaction - self-completed questionnaire

    12 weeks and 52weeks

  • Body composition (BIA)

    Change from baseline to 12 weeks and 52weeks

  • Incidence of treatment-emergent adverse events assessed by 5 grade scale

    Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks.

  • +2 more secondary outcomes

Study Arms (2)

High-intensity interval training - telerehabilitation

EXPERIMENTAL

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

Behavioral: High-Intensity Interval Training

Moderate-intensity continuous training - telerehabilitation

ACTIVE COMPARATOR

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

Behavioral: Moderate-intensity continuous training

Interventions

High-Intensity Interval TrainingBEHAVIORAL

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.

High-intensity interval training - telerehabilitation
Moderate-intensity continuous trainingBEHAVIORAL

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.

Moderate-intensity continuous training - telerehabilitation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Filip Dosbaba, PT, PhD

    University Hospital Brno, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

June 1, 2021

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

there is a plan to make the data on each participant available to other researchers through a web-based data register

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
2020 - 2024
Access Criteria
unlimited, open access

Locations

CZ(1)