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Trial record 41 of 102 for:    High Intensity Interval Training | Recruiting, Not yet recruiting, Available Studies

High-Intensity Aerobic Lifelong Training--AF (HALT-AF)

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ClinicalTrials.gov Identifier: NCT03241433
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This study is a single-center RCT. Potential subjects with symptomatic non-permanent AF will be enrolled to determine the effect of sprint interval training (SIT) in comparison to moderate-intensity continuous training (MICT) and non-exercise control in reducing AF burden. The Investigators will enroll 60 patients during the first 12 months of the study. Baseline data collection will be conducted during the first month after enrollment. After baseline data collection, subjects will be randomized (1:1:1) to SIT vs. MICT vs. non-exercise controls. The exercise training will last for 3 months followed by final data collection which will be completed in 1 month.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: High intensity interval training Other: Moderate intensity continuous training Other: No Exercise Not Applicable

Detailed Description:
Atrial fibrillation (AF) is the most common heart rhythm abnormality in the general population. Current recommended methods to maintain sinus rhythm or reduce AF burden (% time a person is in AF) in patients with non-permanent AF are costly and ineffective. Hence, there is an urgent need to discover novel inexpensive strategies to reduce AF burden. It is well-established that regular aerobic exercise reduces cardiovascular morbidity and mortality; however, adherence to regular exercise is poor rendering it an ineffective public health strategy. Evidence is emerging to suggest that traditional moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) may be associated with lower AF burden. Compared with traditional MICT, HIIT is possibly more time-efficient; hence, it may promote adherence. Since lack of time is the most common reason for poor adherence to regular exercise, the time-efficiency of HIIT holds promise to be a "game-changer". However, many knowledge gaps remain. First, HIIT has never been compared directly with MICT in relation to AF burden; thus, whether HIIT is comparable or superior to MICT is unknown. Second, the time commitment required for a "conventional" HIIT program (120 mins/week) is not substantially less than the recommended MICT (150 mins/week); hence, it is doubtful that it can be a real "game-changer" in terms of promoting adherence. Third, HIIT performed using a cycle ergometer is a safer alternative to the treadmill in older adults, but has not been evaluated in patients with AF. Finally, mechanisms underlying the salutary benefits of exercise in relation to AF burden remain unknown. To address these knowledge gaps, the investigators will evaluate an innovative HIIT program—sprint interval training (SIT)—using a cycle ergometer that only requires 10 minutes per session and 30 minutes per week, in contrast to the "conventional" HIIT program that requires 40 minutes per session and 120 minutes per week. In this pilot randomized controlled trial (RCT), the investigators will randomize 60 subjects with non-permanent AF (1:1:1) to SIT vs. MICT vs. no exercise control. At enrollment, these subjects will undergo heart rhythm monitoring by a non-invasive ambulatory heart rhythm monitor, V02 max testing, assessment of cardiac size and function by cardiac MRI, and assessment of AF symptom severity; these measures will be repeated at 3 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-Intensity Interval Training and Moderate-Intensity Continuous Training in Reducing Atrial Fibrillation Burden
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High intensity interval training
Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 3 X 20-second sprint interval cycling -as fast as possible at 90-95% peak power low intensity- 2 X 2 minute cycling at slow pace 50W
Other: High intensity interval training
exercise by use of stationary cycles

Active Comparator: Moderate intensity continuous training
Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 45 minutes of continuous cycling at 45-60% peak power
Other: Moderate intensity continuous training
exercise by use of stationary cycles

Active Comparator: No exercise
No excercise training will be done
Other: No Exercise
no exercise training will be given and no exercise will be added to subjects routine




Primary Outcome Measures :
  1. Change in AF burden [ Time Frame: 3 months ]
    After 12 weeks of exercise training , HIIT and MICT will be comparable but better than non-exercise control in AFburden(% of time a person is in AF) by using an ambulatory patch monitor


Secondary Outcome Measures :
  1. Change in left atrial and left ventricular size and function [ Time Frame: 3 months ]
    After 12 weeks of exercise training HIIT and MICT will be comparable but better than non-exercise control as Cardiac MRI will be completed to assess LV and LA volumes and function and LV fibrosis

  2. change in clinical outcomes [ Time Frame: 3 months ]
    The favorable effect of HIIT and MICT over non exercise control on clinical outcomes will be attenuated after after for secondary outcomes, suggesting that the latter mediate the clinical benefits of regular aerobic exercise



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • : Patients with symptomatic non-permanent AF and aged 18-65 years who are sedentary (activity ≤0.5 hours/week of regular exercise) and seen by Dr. Chen or his cardiology colleagues at Clinics and Surgery Center (CSC), other Fairview cardiology clinics, and University of Minnesota Medical Center (UMMC). Patients will be screened and enrolled by a research coordinator.

Exclusion Criteria:

  • Individuals lacking the capacity to consent for themselves will not be included, previous open heart surgery, previous catheter ablation for AF, LVEF <45%, significant cardiac valve disease, coronary heart disease without complete revascularization, implanted cardiac electronic device, or GFR <30 mL/min/1.73 m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241433


Contacts
Contact: Lin Yee Chen, MD,MBBS,MS 612-625-4401 chenx484@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Julie Dicken, RN    612-408-4316    dicke022@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Lin Yee Chen, MD,MBBS,MS University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03241433     History of Changes
Other Study ID Numbers: 1703M11461
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Exercise

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes