Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04910997 |
| Other study ID # |
2021-0165 |
| Secondary ID |
1-17-JDF-073 |
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
May 3, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
University of Illinois at Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
