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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High intensity interval training
Moderate intensity continuous training
No Exercise
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

High intensity interval training

Moderate intensity continuous training

No exercise

Arm Description

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

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

No excercise training will be done

Outcomes

Primary Outcome Measures

Change in AF burden
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

Change in left atrial and left ventricular size and function
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
change in clinical outcomes
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

Full Information

First Posted
July 27, 2017
Last Updated
December 18, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03241433
Brief Title
High-Intensity Aerobic Lifelong Training--AF
Acronym
HALT-AF
Official Title
High-Intensity Interval Training and Moderate-Intensity Continuous Training in Reducing Atrial Fibrillation Burden
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Exercise

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training
Arm Type
Active Comparator
Arm Description
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
Arm Title
Moderate intensity continuous training
Arm Type
Active Comparator
Arm Description
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
Arm Title
No exercise
Arm Type
Active Comparator
Arm Description
No excercise training will be done
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
exercise by use of stationary cycles
Intervention Type
Other
Intervention Name(s)
Moderate intensity continuous training
Intervention Description
exercise by use of stationary cycles
Intervention Type
Other
Intervention Name(s)
No Exercise
Intervention Description
no exercise training will be given and no exercise will be added to subjects routine
Primary Outcome Measure Information:
Title
Change in AF burden
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in left atrial and left ventricular size and function
Description
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
Time Frame
3 months
Title
change in clinical outcomes
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Yee Chen, MD,MBBS,MS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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High-Intensity Aerobic Lifelong Training--AF

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