The Effect of Two Exercise Training Protocols on Physiological and Biochemical Parameters in Congestive Heart Failure
1 other identifier
interventional
29
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Feb 2014
Typical duration for not_applicable heart-failure
1 active site
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
December 2, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 25, 2016
October 1, 2016
2.6 years
December 2, 2013
October 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline and following 12 weeks of training
Secondary Outcomes (1)
Peak VO2 change
Pre- and post 12 week exercise program
Other Outcomes (1)
Quality of life questioner (MLWHF)
Pre training and 12 weeks later post exercise training period
Study Arms (2)
Continues aerobic training
ACTIVE COMPARATORTreadmill 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).
Interval Exercse Training
EXPERIMENTALBouts 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.
Interventions
Eligibility Criteria
You may qualify if:
- Stable heart failure patients referred to exercise training in a tertiary care cardiac rehabilitation institute
- Age \> 21
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center, Cardiac Rehabilitation Institute
Tel Hashomer , Ramat Gan, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director Cradiac Rehabilitation Institute, Sheba Medical Center
Study Record Dates
First Submitted
December 2, 2013
First Posted
December 12, 2013
Study Start
February 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 25, 2016
Record last verified: 2016-10