High Intensity Interval Training in Chronic Heart Failure
Primary Purpose
Chronic Heart Failure, Cardiac Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility Criteria
Inclusion Criteria: medically stable chronic heart failure NYHA II-III can perform cardiopulmonary exercise test after 3months with proper medication age 30 to 70 ejection fraction< 40% Exclusion Criteria: contraindication to cardiopulmonary exercise test musculoskeletal problem who cannot perform cardiopulmonary exercise test cognition deficit who cannot understand directions severe medial illness
Sites / Locations
- Inha University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
High intensity interval training
Moderate intensity continous training
Control
Arm Description
Outcomes
Primary Outcome Measures
Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min)
at the end of training, from baseline to 12 weeks
Secondary Outcome Measures
Anaerobic threshold (kg/ml/min)
The anaerobic threshold is the highest exercise intensity that you can sustain for a prolonged period without lactate substantially building up in your blood.
6minute walk test (meter)
maximal heart rate (bpm)
systolic blood pressure (mmHg)
diastolic blood pressure (mmHg)
resting heart rate (bpm)
diastolic blood presure (mmHg)
depression scale by Patient Health Questionnaire
Patient Health Questionnaire (PHQ; range, 0-27; higher score = severe depression; cut-off score of 5 for minimal depression)
anxiety scale by Generalized Anxiety Disorder Scale
Generalized Anxiety Disorder Scale (GAD; range, 0-21; higher score = severe anxiety; cut-off score of 5 for mild anxiety)
fatigue scale by fatigue severity scale
fatigue severity scale (FSS; range, 9-63; higher score = severe fatigue; cut-off score of 4 for fatigue)
Quality of Life (QoL) questionnaire (MacNew)
MacNew QoL questionnaire is a measurement tool for patients with cardiac disease that measures physical, emotional, and social functional levels to provide overall QoL.
Full Information
NCT ID
NCT05659420
First Posted
December 5, 2022
Last Updated
February 28, 2023
Sponsor
Inha University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05659420
Brief Title
High Intensity Interval Training in Chronic Heart Failure
Official Title
The Effect of High-intensity Interval Training and Moderate Intensity Continuous Training on Cardiopulmonary Functions in Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to investigate the effect of high-intensity interval training and moderate intensity continuous training on cardiopulmonary functions in chronic heart failure.
Detailed Description
enroll chronic heart failure patients into 3 randomized controlled group
high intensity interval training
moderate intensity continous training
control
perform cardica rehab for 12 weeks, compare primary and secondary endpoints between baseline and 12 weeks results
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Cardiac Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High intensity interval training
Arm Type
Experimental
Arm Title
Moderate intensity continous training
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor
Intervention Description
aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor
Primary Outcome Measure Information:
Title
Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min)
Description
at the end of training, from baseline to 12 weeks
Time Frame
compare baseline data with 12 weeks rehabilitation data
Secondary Outcome Measure Information:
Title
Anaerobic threshold (kg/ml/min)
Description
The anaerobic threshold is the highest exercise intensity that you can sustain for a prolonged period without lactate substantially building up in your blood.
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
6minute walk test (meter)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
maximal heart rate (bpm)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
systolic blood pressure (mmHg)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
diastolic blood pressure (mmHg)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
resting heart rate (bpm)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
diastolic blood presure (mmHg)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
depression scale by Patient Health Questionnaire
Description
Patient Health Questionnaire (PHQ; range, 0-27; higher score = severe depression; cut-off score of 5 for minimal depression)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
anxiety scale by Generalized Anxiety Disorder Scale
Description
Generalized Anxiety Disorder Scale (GAD; range, 0-21; higher score = severe anxiety; cut-off score of 5 for mild anxiety)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
fatigue scale by fatigue severity scale
Description
fatigue severity scale (FSS; range, 9-63; higher score = severe fatigue; cut-off score of 4 for fatigue)
Time Frame
compare baseline data with 12 weeks rehabilitation data
Title
Quality of Life (QoL) questionnaire (MacNew)
Description
MacNew QoL questionnaire is a measurement tool for patients with cardiac disease that measures physical, emotional, and social functional levels to provide overall QoL.
Time Frame
compare baseline data with 12 weeks rehabilitation data
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medically stable chronic heart failure
NYHA II-III
can perform cardiopulmonary exercise test
after 3months with proper medication
age 30 to 70
ejection fraction< 40%
Exclusion Criteria:
contraindication to cardiopulmonary exercise test
musculoskeletal problem who cannot perform cardiopulmonary exercise test
cognition deficit who cannot understand directions
severe medial illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung-Lim Joa, M.D.
Phone
+82-10-9111-9432
Email
drjoakl@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Lim Joa, M.D.
Organizational Affiliation
Department of physical medicine and rehabilitation, Inha University hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University hospital
City
Incheon
State/Province
Kyunggi-do
ZIP/Postal Code
07980
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung-Lim Joa, M.D.
Phone
+82-10-9111-9432
Email
drjoakl@gmail.com
12. IPD Sharing Statement
Learn more about this trial
High Intensity Interval Training in Chronic Heart Failure
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