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The Effect of Two Exercise Training Protocols on Physiological and Biochemical Parameters in Congestive Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Interval exercise training
Continues aerobic training
Sponsored by
Dr. Robert Klempfner Heart Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Failure focused on measuring Rehabilitation, Exercise Training, Interval training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable heart failure patients referred to exercise training in a tertiary care cardiac rehabilitation institute
  • Age > 21

Exclusion Criteria:

  • Severe symptomatic heart failure
  • Severe orthopedic limitations
  • Unstable arrythmia
  • Cognitive decline or substance abuse
  • Unable to comply with exercise protocol
  • Significant pulmonary disease
  • NYHA 4 heart failure class

Sites / Locations

  • Sheba Medical Center, Cardiac Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continues aerobic training

Interval Exercse Training

Arm Description

Treadmill or exercise bike training with target heart rate of 50-70% of the heart rate reserve (or 50-60% of the peak VO2 reserve). Overall 45 minutes of exercise (including the 5-10 minute warm-up period).

Bouts of high intensity interval treadmill or exercise bike training, comprising of 85-95% of the heart rate reserve (or 80-90% of the peak VO2 reserve), for the duration of 4 minutes, separated by periods of low intensity activity until the heart rate reaches 50% of the peak heart rate. This set will be repeated 3 times.

Outcomes

Primary Outcome Measures

Lactate clearance kinetics
Change from baseline of lactate clearance kinetics followoing a 12 weeks exercise program based on two different training protocol (continues and interval training)

Secondary Outcome Measures

Peak VO2 change
Change from baseline of the peak VO2 following the 12 weeks exercise program

Full Information

First Posted
December 2, 2013
Last Updated
October 23, 2016
Sponsor
Dr. Robert Klempfner Heart Rehabilitation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02009475
Brief Title
The Effect of Two Exercise Training Protocols on Physiological and Biochemical Parameters in Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Robert Klempfner Heart Rehabilitation Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study is to evaluate differential lactate removal kinetics in heart failure patients that are trained according to 2 different exercise protocols: (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT)
Detailed Description
Introduction: Congestive heart failure (CHF) patients suffer from early fatigue and functional aerobic impairment. Their reduced cardiac output and O2 delivery to the peripheral muscles shifts those patients consistent anaerobic metabolism, thus, CHF patients rely on anaerobic metabolism even in everyday life activity. This metabolism leads to a shift of muscles fiber types from mainly slow twitch, oxidative type I fibers to fast twitch, glycolytic type IIb fibers. Monocarboxylate proteins MCT1 and MCT4 transport lactate crosses the membrane. MCT1 is responsible for the lactate uptake and MCT4 is responsible for efflux of excess lactate. Exercise training is known to improve the quality of life in CHF. We hypothesized that exercise training might change MCT1 and 4 expression and distribution. Accordingly, these changes may also affect lactate clearance during recovery, which may contribute to the beneficial effect of exercise training in CHF patients. Methods: New-York Heart association (NYHA) class II-III CHF patients will be assigned to the experiment. At baseline and upon training conclusion they will undergo the same tests battery. The test battery includes heart rate, blood pressure measurements, echocardiographic evaluation. All participants will fill out "Minnesota living with heart failure" questionnaire. Subsequently, after their basal blood lactate will be assessed they will undergo measurement which will be followed by lactate clearance-rate evaluation. Randomly each patient will then be assigned to one of two experimental training groups: (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT). Each volunteer will be trained twice a week for 12 weeks, according to his/hers assigned training protocol and in accordance to exercise training guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Rehabilitation, Exercise Training, Interval training

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continues aerobic training
Arm Type
Active Comparator
Arm Description
Treadmill or exercise bike training with target heart rate of 50-70% of the heart rate reserve (or 50-60% of the peak VO2 reserve). Overall 45 minutes of exercise (including the 5-10 minute warm-up period).
Arm Title
Interval Exercse Training
Arm Type
Experimental
Arm Description
Bouts of high intensity interval treadmill or exercise bike training, comprising of 85-95% of the heart rate reserve (or 80-90% of the peak VO2 reserve), for the duration of 4 minutes, separated by periods of low intensity activity until the heart rate reaches 50% of the peak heart rate. This set will be repeated 3 times.
Intervention Type
Other
Intervention Name(s)
Interval exercise training
Intervention Type
Other
Intervention Name(s)
Continues aerobic training
Primary Outcome Measure Information:
Title
Lactate clearance kinetics
Description
Change from baseline of lactate clearance kinetics followoing a 12 weeks exercise program based on two different training protocol (continues and interval training)
Time Frame
Baseline and following 12 weeks of training
Secondary Outcome Measure Information:
Title
Peak VO2 change
Description
Change from baseline of the peak VO2 following the 12 weeks exercise program
Time Frame
Pre- and post 12 week exercise program
Other Pre-specified Outcome Measures:
Title
Quality of life questioner (MLWHF)
Time Frame
Pre training and 12 weeks later post exercise training period

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable heart failure patients referred to exercise training in a tertiary care cardiac rehabilitation institute Age > 21 Exclusion Criteria: Severe symptomatic heart failure Severe orthopedic limitations Unstable arrythmia Cognitive decline or substance abuse Unable to comply with exercise protocol Significant pulmonary disease NYHA 4 heart failure class
Facility Information:
Facility Name
Sheba Medical Center, Cardiac Rehabilitation Institute
City
Tel Hashomer , Ramat Gan
Country
Israel

12. IPD Sharing Statement

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The Effect of Two Exercise Training Protocols on Physiological and Biochemical Parameters in Congestive Heart Failure

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