Type 2 DiabetesNCT04910997
Heart Rate Variability-Guided Exercise Training in Type 2 Diabetes
A study testing Aerobic exercise training in people with Type 2 Diabetes and Diabetes Mellitus, Type 2, run by University of Illinois at Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus in Obese
- What is being tested?
- Aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 3 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
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.
Read the 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.
- Being tested
- Aerobic exercise training
- Keywords
- Exercise, Aerobic exercise, Exercise training, Glucose control, Autonomic function
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingOther
Combination of supervised and home-based aerobic exercise training
| Study group | Role | What they receive |
|---|---|---|
| HRV Group | Experimental | Heart rate variability training group Receives: Other: Aerobic exercise training |
| Traditional Exercise Group | Active comparator | Traditional (e.g. standard) exercise training Receives: Other: Aerobic exercise training |
| Control Group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak aerobic capacity (fitness)
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.
Measured: 4 months
Secondary outcomes (5)
Glucose control
HbA1c (glycated hemoglobin) will be the marker of glucose control in this study. HbA1c will be reported as a percentage (%).
Measured: 4 months
Baroreflex sensitivity
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.
Measured: 4 months
Quality of life questionnaire
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.
Measured: 4 months
Fatigue severity scale
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.
Measured: 4 months
Depression questionnaire
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion2 May 2022 (estimated)
- Study completion3 May 2022
Why it stopped: Protocol closed, no participants enrolled, difficulty enrolling, funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Erin Vidra, University of Illinois at Chicago
- Investigators
- Baynard, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910997
- Sponsor's protocol ID
- 2021-0165
- Other IDs
- 1-17-JDF-073
- Status last verified
- Apr 2023
- First submitted
- 18 May 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability-Guided Exercise Training in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04910997
- Acronym / sponsor ID
- 2021-0165
- Keywords
- Exercise, Aerobic exercise, Exercise training, Glucose control, Autonomic function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol closed, no participants enrolled, difficulty enrolling, funding ended.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 2 May 2022 (estimated)
- Study completion
- 3 May 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HRV Group | Experimental | Other: Aerobic exercise trainingHeart rate variability training group |
| Traditional Exercise Group | Active comparator | Other: Aerobic exercise trainingTraditional (e.g. standard) exercise training |
| Control Group | No intervention | –Usual care |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise trainingCombination of supervised and home-based aerobic exercise training | Other | HRV Group, Traditional Exercise Group |
Primary outcome
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.
5 secondary outcomes
Glucose control
Time frame: 4 months
Baroreflex sensitivity
Time frame: 4 months
Quality of life questionnaire
Time frame: 4 months
Fatigue severity scale
Time frame: 4 months
Depression questionnaire
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baynard principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training in people with Type 2 Diabetes and Diabetes Mellitus, Type 2, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak aerobic capacity (fitness) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 29 Oct 2026.