Heart Rate Variability-Guided Exercise Training in Type 2 Diabetes

NCT ID: NCT04910997

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-05-03

Brief Summary

The primary aim of this randomized clinical trial is to determine the effectiveness of a 16 wk individualized aerobic exercise program, using heart rate variability to guide the exercise prescription, for increasing aerobic capacity of individuals with type 2 diabetes, compared to a traditional exercise training paradigm and usual care. To accomplish this aim the investigators plan to test for greater improvements in: 1) fitness (primary outcome); as well as secondary variables of 2) cardiovascular autonomic function via baroreflex function; 3) glucose control (HbA1c); and 4) psychosocial factors.

Detailed Description

This study will examine participant's fitness levels before and after a 16 week intervention period. There are two study visits prior to starting the intervention period. During Baseline Study Visit #1, the investigators will take a health history, determine the height and weight of the participants, and have participants complete a physical activity questionnaire and a 3-day diet log, as well as determine muscle and fat mass, followed by tests that examine how blood vessels function, and lastly a treadmill test to determine aerobic fitness. During Baseline Study Visit #2, which takes place 5-7 days later, the investigators will measure blood pressure, heart rate, and glucose control through a glucose challenge test. The glucose challenge tests requires taking ~3 Tablespoons of blood to be assessed for glucose, insulin and hemoglobin A1c. Lastly, participants will complete 3 questionnaires regarding quality of life, fatigue, and depression.

After completion of the two pre-training data collection visits, participants will be randomized to 1 of 3 groups: 1) HRV-guided exercise group (HRV); 2) traditional exercise training group (TRAD); or 3) usual care group. There will be approximately 30 subjects in each group, providing an equal chance of being assigned to either group. Both the HRV and TRAD groups will participate in a combined lab-supervised and home-based exercise program (with 1 day1 per week supervised in the laboratory and 3 days per week at home) over the course of 16 weeks. Furthermore, both exercise groups will participate in online/phone counseling in order to provide support. Specifically, participants will be provided with a phone number to the lab to call study personnel for assistance if needed. Weekly internet video chats through Zoom or phone calls, if Zoom is unavailable, will be conducted by a trained exercise-behavior change coach to help participants focus on self-efficacy, outcome expectations, impediments (barriers), and goal setting.

Post-training testing Visits #3 and #4 Visits #3 and #4 will be identical to visits #1 and 2, with the exception that the demographic questionnaire will not be administered again. This will mean there is a total of 100 mL of blood taken over the course of the entire study, between Visits 2 and 4 combined, which will total ~6 total Tablespoons.

Conditions

Type 2 Diabetes; Diabetes Mellitus, Type 2; Type 2 Diabetes Mellitus in Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HRV Group

Heart rate variability training group

Group Type: EXPERIMENTAL

Aerobic exercise training

Intervention Type: OTHER

Combination of supervised and home-based aerobic exercise training

Traditional Exercise Group

Traditional (e.g. standard) exercise training

Group Type: ACTIVE_COMPARATOR

Aerobic exercise training

Intervention Type: OTHER

Combination of supervised and home-based aerobic exercise training

Control Group

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic exercise training

Combination of supervised and home-based aerobic exercise training

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Body mass index range = 30.0 to 40.0 kg/m2
• Being sedentary (<1 h regular physical activity/wk)
• Medication stable for 3 mo.
• Current use of physician confirmed diabetes medication, fasting glucose values ≥ 126 mg/dL and 2 hr oral glucose tolerance test (OGTT) values ≥ 200 mg/dL will be used as the criteria for type 2 diabetes

Exclusion Criteria

• Type 1 diabetes, [insulin use]
• Major depressive disorder
• Severe neuropathy
• Current tobacco use (must have quit for 1 yr or more if a previous user)
• Renal, liver, peripheral artery, or carotid artery disease
• Current cancer (must be at least 6 mo cancer-free)
• Beta-blockers
• Perimenopausal women, post-menopausal women experiencing hot flushes and not on hormone therapy
• Alcohol consumption greater than 7 drinks/wk
• Acute coronary syndrome within the last 6 mo, heart failure, pacemaker, and any additional contraindications to participation in exercise testing or an exercise training program.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Erin Vidra

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baynard

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

1-17-JDF-073

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-0165

Identifier Type: -

Identifier Source: org_study_id