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N/A N=52 Randomized Prevention

Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans

Obesity · Insulin Resistance · Sedentary Lifestyle

Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Cardiorespiratory Fitness — -0.15; 0.12; 0.22 Liters of oxygen/min — p=0.006

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Moderate intensity exercise training (MOD-INT) (Behavioral); High Intensity exercise training (HI-INT) (Behavioral)
Age
Adult, Older Adult · 35+ yrs
Sex
All
Sponsor
East Carolina University
Primary completion
Aug 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Cardiorespiratory Fitness
-0.15; 0.12; 0.22 0.006 sig
SECONDARY
Change in Body Fat Percentage
0.09; -0.26; -0.71 0.276
SECONDARY
Change in Body Weight
0.87; -0.37; -0.42 0.370
SECONDARY
Change in Waist Circumference
-1.42; 0.41; -1.3 0.932
SECONDARY
Change in Low Density Lipoprotein
-7.1; -0.12; 2.3 0.136
SECONDARY
Change in High Density Lipoprotein
-3.4; -1.1; 1.3 0.056
SECONDARY
Changes in Total Cholesterol
-10.4; -0.21; -0.71 0.224
SECONDARY
Change in Triglycerides
-10.9; 4.0; -13.3 0.783
SECONDARY
Change in Systemic Inflammation
0.142; 0.159; 0.31 0.940
SECONDARY
Change in Fasting Glucose
-2.81; -2.5; -2.0 0.769
SECONDARY
Change in Insulin
-2.68; -2.69; -2.7 1.000
SECONDARY
Change in Insulin Sensitivity
0.60; 0.59; 0.44 0.821
SECONDARY
Change in Arterial Stiffness
-0.21; 0.68; 0.47 0.093
SECONDARY
Change in Mitochondrial Enzymes
-0.17; 0.02; -0.02; -0.01; 0.02; 0.17 0.424
SECONDARY
Change in Quality of Life
-1.6; 1.3; -1.0; -0.18; 0.57; 2.4 0.756
SECONDARY
Change in Quality of Life (Mental Health and Physical Health Summary Scores)
0.75; -2.7; 1.6; -2.02; 0.02; -0.11 0.650
SECONDARY
Changes in Physical Activity Levels
604.2; 2311.0; 2242.3 0.109
SECONDARY
Change in Dietary Composition

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. 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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02892331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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