- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04033523
High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure
July 24, 2019 updated by: Jong-Shyan Wang, Chang Gung Memorial Hospital
Consumptive coagulopathy is associated with increased mortality in patients with heart failure (HF).
Physical activity influences the risk of major vascular thrombotic events.
This study investigates how high-intensity interval training (HIIT) affects the capacity of endogenous thrombin generation (TG) by modulating circulatory procoagulant microparticles (MPs) in HF patients.
Thirty-eight HF patients and 38 age- and gender-matched normal counterparts (NC) were recruited into this study.
The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks, whereas the NC group did not receive any form of intervention.
Plasma TG kinetics, procoagulant MPs, coagulation-related factors, and oxidative stress/proinflammatory status were analyzed.
The results demonstrated that the HF group exhibited (i) less endogenous thrombin potential (ETP) and TG rate, (ii) lower concentration/activity of tissue factor (TF) and counts of TF-rich MPs derived from blood cells, and (iiii) higher vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations, compared to the NC group did.
However, HIIT elevated plasma ETP and TG rate, as well as, TF concentration/activity and blood cell-derived procoagulant MP levels in the HF patients.
Moreover, the exercise regimen also decreased vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations in patients with HF.
Hence, we conclude that HF reduces the capacity of endogenous TG in plasma, which is associated with decreased (or consumed) circulatory procoagulant MP levels.
However, HIIT alleviates HF-declined endogenous TG capacity and vascular endothelial damage through recuperating TF-related coagulation activity and suppressing oxidative stress/proinflammatory status.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The HF was diagnosed if the patients had a left ventricular ejection fraction (LVEF) <40%.
- All HF patients were New York Heart Association (NYHA) functional class II or III and had received optimal treatment for at least 12 months according to American Heart Association/American College of Cardiology guidelines.
Exclusion Criteria:
- Patients with the presence of atrial fibrillation/flutter, second/third degree heart block, history of life-threatening ventricular arrhythmias, recent unstable angina, myocardial infarction or coronary revascularization (<4 weeks), uncontrolled diabetes mellitus, severe chronic obstructive pulmonary disease, or symptomatic cerebral vascular disease within 12 months, collagen vascular disease, alcohol or drug abuse during the previous 12 months or significant renal or hepatic disease were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity-interval training (HIIT)
The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks
|
The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks
|
No Intervention: normal counterparts
gender-matched normal counterparts (NC) did not receive any form of intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microparticles derived from blood cells and shedding endothelial cells
Time Frame: 12 weeks
|
Platelet-poor plasma (PPP) was separated from whole blood by centrifugation at 1,600g for 10 min at room temperature. The quantification of microparticles in PPP was determined by a three-color FACScan flow cytometer. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiopulmonary fitness
Time Frame: 12 weeks
|
evaluate cardiac hemodynamic response to exercise by noninvasive continuous cardiac output monitoring system
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thrombin generation assay
Time Frame: 12 weeks
|
PPP was measure the rate of thrombin generation using the calibrated automated thrombogram (CAT) assay (Synapse/Thrombinoscope BV).
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2013
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
July 24, 2019
First Posted (Actual)
July 26, 2019
Study Record Updates
Last Update Posted (Actual)
July 26, 2019
Last Update Submitted That Met QC Criteria
July 24, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201301077A3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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