- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04910997
Heart Rate Variability-Guided Exercise Training in Type 2 Diabetes
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tracy Baynard, PhD
- Phone Number: 312-413-1962
- Email: tbaynard@uic.edu
Study Contact Backup
- Name: Sara Sherman
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60608
- University of Illinois at Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Usual care
|
|
Experimental: HRV Group
Heart rate variability training group
|
Combination of supervised and home-based aerobic exercise training
|
Active Comparator: Traditional Exercise Group
Traditional (e.g.
standard) exercise training
|
Combination of supervised and home-based aerobic exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak aerobic capacity (fitness)
Time Frame: 4 months
|
Aerobic capacity (e.g.
fitness) will be measured during a treadmill test that assess how much oxygen the muscles need during exercise.
Aerobic capacity (VO2peak) will be reported as mL/min/kg.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose control
Time Frame: 4 months
|
HbA1c (glycated hemoglobin) will be the marker of glucose control in this study.
HbA1c will be reported as a percentage (%).
|
4 months
|
Baroreflex sensitivity
Time Frame: 4 months
|
This secondary outcome will be our assessment of autonomic function, whereby blood pressure and heart rate are assessed in relation to each other to create a variable called baroreflex sensitivity and reported as ms/mm Hg.
Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP.
|
4 months
|
Quality of life questionnaire
Time Frame: 4 months
|
This will be assessed using the Short-Form (SF)-36 Health Survey questionnaire.
Scores range between 0-100.
A higher score indicates a better health status.
|
4 months
|
Fatigue severity scale
Time Frame: 4 months
|
This outcome will assess perceived fatigue via a questionnaire that contains 9 questions.
The minimum score is 9, with the maximum score being 63.
The higher the score the greater the fatigue severity.
|
4 months
|
Depression questionnaire
Time Frame: 4 months
|
This outcome will be assess via the Hospital Anxiety and Depression Scale (HADS), which is a questionnaire.
There are 14 questions, and the scores can range between 0 to 21 for depression, and 0 to 21 for anxiety.
A lower score means less depressive symptoms and/or anxieity.
|
4 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Baynard, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0165
- 1-17-JDF-073 (Other Grant/Funding Number: American Diabetes Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaRecruiting
Clinical Trials on Aerobic exercise training
-
UNC Lineberger Comprehensive Cancer CenterCompletedStem Cell Transplantation, HematopoieticUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Riphah International UniversityCompletedSpinal Cord InjuriesPakistan
-
University of HoustonTerminated
-
Istanbul University - Cerrahpasa (IUC)CompletedObstructive Sleep Apnea SyndromeTurkey
-
University of Alberta, Physical EducationCanadian Breast Cancer Research AllianceCompleted
-
Chang Gung Memorial HospitalCompleted
-
Chang Gung Memorial HospitalUnknownStroke Patients With Cognitive DeclineTaiwan
-
Federal University of UberlandiaSuspendedHypertension | Dyslipidemias | Multimorbidity | Multiple Chronic ConditionsBrazil
-
Parkwood Hospital, London, OntarioCanadian Institutes of Health Research (CIHR); University of Western Ontario...CompletedCognitive ImpairmentCanada