ObesityHI-PACENCT02892331
Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans
A study testing Moderate intensity exercise training (MOD-INT) and High Intensity exercise training (HI-INT) in people with Obesity and Insulin Resistance, run by East Carolina University at 1 site in United States.
Trial summary
African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians; however, very little data are available on the effects of exercise training on type 2 diabetes risk factors in at risk African Americans. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Sedentary Lifestyle
- What is being tested?
- Moderate intensity exercise training (MOD-INT) and High Intensity exercise training (HI-INT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Body mass index 30-45 kg/m2
- sedentary/low active (step count ≤ 6,500 step/day)
- capable and willing to give written informed consent and understand exclusion criteria
- willingness to accept group assignment from randomization
- No resistance training and no structured aerobic exercise for > 20 minutes per day, 3+ days per week, for the last 6 months
- conditions that are contraindicated for exercise training
Who cannot join
- Resting blood pressure > 180 mm Hg systolic and/or >100 mm Hg diastolic; individuals on blood pressure medications meeting the blood pressure criteria are eligible
- Diagnosis of type 1 or 2 diabetes, and/or fasting glucose >125 mg/dL
- Medication for the treatment of type 1 or type 2 diabetes
- Bariatric surgery including gastric banding or bypass (potential effects on energy intake)
- Factors that may limit adherence to intervention or affect conduct of the trial
- Unable or unwilling to communicate with staff
Show all 30Show fewer
- Failure to complete run-in or baseline testing
- Hospitalization for depression or severe mental illness in the last 6 months
- Not physically capable of performing the exercise required of the study protocol
- Consuming more than 14 alcoholic beverages per week
- Plan to be away from the Pitt County area more than 3 weeks in the next 3 months
- Lack support from a primary health care provider or family members
- Significant weight loss in the past year (> 20 pounds) or are currently using weight loss medications.
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Another member of the household who is currently a participant or staff member of this study
- Other temporary intervening event, such as sick spouse, or bereavement
- Other medical, psychiatric, or behavioral limitations that may interfere with study participation or the ability to follow the intervention protocol
- Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
- Cancer requiring treatment in the past 5 years with anything but excellent prognosis
- Self-reported HIV, tuberculosis, Hepatitis B, or Hepatitis C
- History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurism, myocardial infarction or heart transplantation
- Renal disease: urine protein > 100 mg/dl, serum creatinine ≥ 1.5 mg/dl or currently receiving dialysis.
- Auto-immune diseases (such as Lupus, Multiple Sclerosis, Graves' disease, or Rheumatoid arthritis)
- Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol
- History of stroke or transient ischemic attack
- History of vascular aneurysms
- History of bleeding disorders
- Pregnancy or plans to become pregnant
- Dieting or plans to diet, or in a weight loss program
- Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: The High Intensity Exercise to Promote Accelerated Improvements in CardiorEspiratory Fitness (HI-PACE) Study
African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians; however, very little data are available on the effects of exercise training on type 2 diabetes risk factors in at risk African Americans. The present proposal will evaluate the effects of 6 months of moderate versus vigorous intensity aerobic exercise training on fitness, insulin sensitivity, mitochondrial capacity, skeletal muscle oxidative/insulin sensitivity markers, adiposity, and quality of life in African Americans.
Read the detailed description
African Americans have a much greater risk of type 2 diabetes compared to Caucasians in the United States. Similarly, recent evidence has emerged that fitness level, a major risk factor for type 2 diabetes also tends to be lower in African Americans. Many scientific studies have shown that exercise training has a beneficial impact on fitness levels and a variety of other type 2 diabetes risk factors such as the reduction of glucose/insulin levels, and body fat Importantly, studies performed in mostly Caucasian populations suggest that exercise training at a vigorous intensity may promote greater improvements in type 2 diabetes risk factors compared to moderate intensity exercise, which may suggest that it has greater promise in reducing type 2 diabetes risk. However, few exercise training studies compare the health benefits of different exercise training programs (such as exercise intensity) in African Americans, which is clinically important due to their greater type 2 diabetes risk, and that fact that they are less likely to meet public health recommendations for physical activity compared to their Caucasian counterparts.
The High Intensity exercise to Promote Accelerated improvements in CardiorEspiratory fitness (HI-PACE) study will evaluate the effect of exercise intensity on cardiorespiratory fitness (CRF) and insulin sensitivity in obese (BMI: 30-45) African Americans (40-65 yrs.) with at least 1 additional T2D risk factor. Participants (n=60) will be recruited in collaboration with the ECU Center for Health Disparities, and subsequently randomized to moderate intensity (MOD-INT, n=20) or high intensity (HIGH-INT, n=20) aerobic exercise training, or to a control group (CON, n=20) for 24 weeks. Supervised exercise training will be performed at a heart rate associated with ~50% and ~75% of VO2 max in the MOD-INT and the HIGH-INT groups, respectively at the same exercise volume of 600 MET-minutes per week (consistent with public health recommendations). The primary outcome is the change in CRF, which will be assessed at baseline, mid-intervention, and follow-up. Insulin sensitivity will be measured via an intravenous glucose tolerance test at baseline and follow-up. Other secondary measures include mitochondrial oxidative capacity using infrared and measurements on muscle biopsies (PGC-1α and other indices of mitochondrial content), the expression of a protein involved with insulin action (GLUT-4 expression) in skeletal muscle as well as systemic inflammation, adiposity, quality of life and exercise enjoyment measures.
- Conditions
- Obesity, Insulin Resistance, Sedentary Lifestyle
- Being tested
- Moderate intensity exercise training (MOD-INT), High Intensity exercise training (HI-INT)
- Keywords
- exercise, insulin resistance, mitochondrial function, arterial stiffness, exercise intensity, fitness
- Medical subject headings
- Obesity, Insulin Resistance, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exercise training (MOD-INT)Behavioural
Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
High Intensity exercise training (HI-INT)Behavioural
Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete |
| MOD-INT | Experimental | The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks Receives: Behavioral: Moderate intensity exercise training (MOD-INT) |
| HIGH-INT | Experimental | High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks Receives: Behavioral: High Intensity exercise training (HI-INT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiorespiratory Fitness
Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Maximal oxygen consumption (Liters of O2 per minute) will be measured using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).
Measured: Baseline and 24 weeks
Secondary outcomes (17)
Change in Body Fat Percentage
Dual-energy X-ray absorptiometry will be used to measure changes in body fat percentage
Measured: Baseline and 24 weeks
Change in Body Weight
Weight will be measured using a calibrated scale. Weight will be measured in kg
Measured: Baseline and 24 weeks
Change in Waist Circumference
Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes.
Measured: Baseline and 24 weeks
Change in Low Density Lipoprotein
Low density lipoprotein will be measured from a fasting blood sample
Measured: Baseline and 24 Weeks
Change in High Density Lipoprotein
High density lipoprotein will be measured from a fasted blood sample
Measured: Baseline and 24 Weeks
Changes in Total Cholesterol
Total Cholesterol will be measured in a fasting blood sample
Measured: Baseline and 24 weeks
Change in Triglycerides
Triglyceride levels will be measured from a fasting blood sample
Measured: Baseline and 24 Weeks
Change in Systemic Inflammation
High sensitivity c-reactive protein will be measured at baseline and follow-up
Measured: Baseline and 24 weeks
Change in Fasting Glucose
Fasting glucose will be measured from a fasting blood sample
Measured: Baseline and 24 Weeks
Change in Insulin
Fasting insulin value will be measured from a blood sample
Measured: Baseline and 24 Weeks
Change in Insulin Sensitivity
Insulin sensitivity will be measured using an intravenous glucose tolerance test
Measured: Baseline and 24 weeks
Change in Arterial Stiffness
Arterial stiffness will be measured using pulse wave velocity.
Measured: Baseline and 24 weeks
Change in Mitochondrial Enzymes
Mitochondrial enzymes (citrate synthase, pgc1aplha and complex1-5)
Measured: Baseline and 24 weeks
Change in Quality of Life
Quality of life (QOL) will be measured by the short form health survey (SF-36). SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status).
Measured: Baseline and 24 weeks
Change in Quality of Life (Mental Health and Physical Health Summary Scores)
The SF-36 also produces a measure of overall physical health (physical component score [PCS]) and overall mental health (mental component score [MCS]). Scoring of these items are standardized using means and standard deviations from the general US population. Aggregate PCS and MCS scores are standardized using a linear T-Score transformation to have a mean of 50 and a standard deviation of 10. A higher score indicates better quality of life and a lower score indicates worsened quality of life.
Measured: Baseline to 24 Weeks
Changes in Physical Activity Levels
Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The change in steps will be be evaluated from baseline to 24 weeks
Measured: Baseline and 24 Weeks
Change in Dietary Composition
Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damon Swift, East Carolina University
- Investigators
- Damon L Swift, Ph.D., Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892331
- Sponsor's protocol ID
- 1R03DK105297-01A1
- Acronym
- HI-PACE
- Status last verified
- Jun 2024
- First submitted
- 30 Aug 2016
- Last updated
- 13 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McGee JE, Barefoot SG, Gniewek NR, Brophy PM, Clark A, Dubis GS, Ryan TE, Houmard JA, Vos P, Raedeke TD, Swift DL. High-intensity exercise to promote accelerated improvements in cardiorespiratory fitness (HI-PACE): study protocol for a randomized controlled trial. Trials. 2019 Aug 8;20(1):484. doi: 10.1186/s13063-019-3611-1.
PubMed 31395096
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The High Intensity Exercise to Promote Accelerated Improvements in CardiorEspiratory Fitness (HI-PACE) Study
- ClinicalTrials.gov ID
- NCT02892331
- Acronym / sponsor ID
- HI-PACE / 1R03DK105297-01A1
- Conditions
- Obesity, Insulin Resistance, Sedentary Lifestyle
- Keywords
- exercise, insulin resistance, mitochondrial function, arterial stiffness, exercise intensity, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 13 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians; however, very little data are available on the effects of exercise training on type 2 diabetes risk factors in at risk African Americans. The present proposal will evaluate the effects of 6 months of moderate versus vigorous intensity aerobic exercise training on fitness, insulin sensitivity, mitochondrial capacity, skeletal muscle oxidative/insulin sensitivity markers, adiposity, and quality of life in African Americans.
Detailed description
African Americans have a much greater risk of type 2 diabetes compared to Caucasians in the United States. Similarly, recent evidence has emerged that fitness level, a major risk factor for type 2 diabetes also tends to be lower in African Americans. Many scientific studies have shown that exercise training has a beneficial impact on fitness levels and a variety of other type 2 diabetes risk factors such as the reduction of glucose/insulin levels, and body fat Importantly, studies performed in mostly Caucasian populations suggest that exercise training at a vigorous intensity may promote greater improvements in type 2 diabetes risk factors compared to moderate intensity exercise, which may suggest that it has greater promise in reducing type 2 diabetes risk. However, few exercise training studies compare the health benefits of different exercise training programs (such as exercise intensity) in African Americans, which is clinically important due to their greater type 2 diabetes risk, and that fact that they are less likely to meet public health recommendations for physical activity compared to their Caucasian counterparts.
The High Intensity exercise to Promote Accelerated improvements in CardiorEspiratory fitness (HI-PACE) study will evaluate the effect of exercise intensity on cardiorespiratory fitness (CRF) and insulin sensitivity in obese (BMI: 30-45) African Americans (40-65 yrs.) with at least 1 additional T2D risk factor. Participants (n=60) will be recruited in collaboration with the ECU Center for Health Disparities, and subsequently randomized to moderate intensity (MOD-INT, n=20) or high intensity (HIGH-INT, n=20) aerobic exercise training, or to a control group (CON, n=20) for 24 weeks. Supervised exercise training will be performed at a heart rate associated with ~50% and ~75% of VO2 max in the MOD-INT and the HIGH-INT groups, respectively at the same exercise volume of 600 MET-minutes per week (consistent with public health recommendations). The primary outcome is the change in CRF, which will be assessed at baseline, mid-intervention, and follow-up. Insulin sensitivity will be measured via an intravenous glucose tolerance test at baseline and follow-up. Other secondary measures include mitochondrial oxidative capacity using infrared and measurements on muscle biopsies (PGC-1α and other indices of mitochondrial content), the expression of a protein involved with insulin action (GLUT-4 expression) in skeletal muscle as well as systemic inflammation, adiposity, quality of life and exercise enjoyment measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete |
| MOD-INT | Experimental | Behavioral: Moderate intensity exercise training (MOD-INT)The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks |
| HIGH-INT | Experimental | Behavioral: High Intensity exercise training (HI-INT)High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- African American
- Body mass index 30-45 kg/m2
- sedentary/low active (step count ≤ 6,500 step/day)
- capable and willing to give written informed consent and understand exclusion criteria
- willingness to accept group assignment from randomization
Key exclusion criteria (30 listed)
- Resting blood pressure > 180 mm Hg systolic and/or >100 mm Hg diastolic; individuals on blood pressure medications meeting the blood pressure criteria are eligible
- Diagnosis of type 1 or 2 diabetes, and/or fasting glucose >125 mg/dL
- Medication for the treatment of type 1 or type 2 diabetes
- Bariatric surgery including gastric banding or bypass (potential effects on energy intake)
- Factors that may limit adherence to intervention or affect conduct of the trial
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 |
|---|---|---|
| Moderate intensity exercise training (MOD-INT)Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes) | Behavioural | MOD-INT |
| High Intensity exercise training (HI-INT)Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3 | Behavioural | HIGH-INT |
Primary outcome
Change in Cardiorespiratory Fitness
Time frame: Baseline and 24 weeks
Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Maximal oxygen consumption (Liters of O2 per minute) will be measured using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).
17 secondary outcomes
Change in Body Fat Percentage
Time frame: Baseline and 24 weeks
Change in Body Weight
Time frame: Baseline and 24 weeks
Change in Waist Circumference
Time frame: Baseline and 24 weeks
Change in Low Density Lipoprotein
Time frame: Baseline and 24 Weeks
Change in High Density Lipoprotein
Time frame: Baseline and 24 Weeks
Changes in Total Cholesterol
Time frame: Baseline and 24 weeks
Change in Triglycerides
Time frame: Baseline and 24 Weeks
Change in Systemic Inflammation
Time frame: Baseline and 24 weeks
Change in Fasting Glucose
Time frame: Baseline and 24 Weeks
Change in Insulin
Time frame: Baseline and 24 Weeks
Change in Insulin Sensitivity
Time frame: Baseline and 24 weeks
Change in Arterial Stiffness
Time frame: Baseline and 24 weeks
Change in Mitochondrial Enzymes
Time frame: Baseline and 24 weeks
Change in Quality of Life
Time frame: Baseline and 24 weeks
Change in Quality of Life (Mental Health and Physical Health Summary Scores)
Time frame: Baseline to 24 Weeks
Changes in Physical Activity Levels
Time frame: Baseline and 24 Weeks
Change in Dietary Composition
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31395096McGee JE, Barefoot SG, Gniewek NR, Brophy PM, Clark A, Dubis GS, Ryan TE, Houmard JA, Vos P, Raedeke TD, Swift DL. High-intensity exercise to promote accelerated improvements in cardiorespiratory fitness (HI-PACE): study protocol for a randomized controlled trial. Trials. 2019 Aug 8;20(1):484. doi: 10.1186/s13063-019-3611-1.
- 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.
Damon L Swift, Ph.D. principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity exercise training (MOD-INT) and High Intensity exercise training (HI-INT) in people with Obesity and Insulin Resistance, run by East Carolina University 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 7 inclusion and 30 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: finished, as of the sponsor's last update on 13 Jun 2024. 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?
Yes. Results are posted in the registry (first posted 13 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Cardiorespiratory Fitness (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892331, which also lists 1 linked publication.
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 13 Jun 2024.