Trial Outcomes & Findings for Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men (NCT NCT01787617)
NCT ID: NCT01787617
Last Updated: 2024-10-31
Results Overview
An oral glucose tolerance test is a medical test in which glucose is given and blood samples are taken afterward to determine how quickly it is cleared from the blood. The test is usually used to test for diabetes or insulin resistance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
Baseline, week 10, week 20
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
Control Group
We will randomly assign 52 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
We will randomly assign 52 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
57
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Baseline characteristics by cohort
| Measure |
Control Group
n=56 Participants
We will randomly assign 52 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 52 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
53.6 Years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
50.54 Years
STANDARD_DEVIATION 9.59 • n=7 Participants
|
51.99 Years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
57 participants
n=7 Participants
|
113 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 10, week 20Population: The number analyzed differs by row because some participants did not complete the follow-up measures.
An oral glucose tolerance test is a medical test in which glucose is given and blood samples are taken afterward to determine how quickly it is cleared from the blood. The test is usually used to test for diabetes or insulin resistance.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.
Baseline
|
110.51 uU/mL
Standard Error 8.14
|
106.64 uU/mL
Standard Error 7.77
|
|
Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.
Week 10
|
90.68 uU/mL
Standard Error 8.13
|
80.23 uU/mL
Standard Error 6.52
|
|
Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.
Week 20
|
86.7 uU/mL
Standard Error 7.3
|
80.74 uU/mL
Standard Error 7.25
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
Blood pressure was measured at rest using a standard mercury sphygmomanometer.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
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Diastolic Blood Pressure
Baseline
|
81.2 mmHg
Standard Error 1.04
|
81.74 mmHg
Standard Error 1.16
|
|
Diastolic Blood Pressure
Week 10
|
72.13 mmHg
Standard Error 1.04
|
70.8 mmHg
Standard Error 1.06
|
|
Diastolic Blood Pressure
Week 20
|
79.16 mmHg
Standard Error 1.09
|
79.85 mmHg
Standard Error 1.27
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
Blood pressure was measured at rest using a standard mercury sphygmomanometer.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Systolic Blood Pressure
Baseline
|
123.04 mm Hg
Standard Error 1.5
|
124.39 mm Hg
Standard Error 1.62
|
|
Systolic Blood Pressure
Week 10
|
116.13 mm Hg
Standard Error 1.53
|
114.84 mm Hg
Standard Error 1.64
|
|
Systolic Blood Pressure
Week 20
|
120.06 mm Hg
Standard Error 1.6
|
122.68 mm Hg
Standard Error 1.76
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
Body composition was assessed using the General Electric (General Electric; Milwaukee, WI) Lunar i-Dual energy X-ray absorptiometry.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Body Composition
Baseline
|
100.79 kg
Standard Error 2.54
|
99.75 kg
Standard Error 2.25
|
|
Body Composition
Week 20
|
99.46 kg
Standard Error 2.82
|
97.97 kg
Standard Error 2.39
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
Fitness testing is being used as a measure of change in the aerobic component of the intervention. Cardiorespiratory fitness maximal exercise tests were conducted using a standardized graded exercise testing protocol administered on a treadmill.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Cardiorespiratory Fitness
Baseline
|
2.41 L/min of oxygen
Standard Error 0.07
|
2.41 L/min of oxygen
Standard Error 0.07
|
|
Cardiorespiratory Fitness
Week 20
|
2.3 L/min of oxygen
Standard Error 0.09
|
2.6 L/min of oxygen
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
Strength testing is performed in order to assess change in response to the resistance training program. Muscular strength is measured via isokinetic testing on a Biodex System 4 Isokinetic Dynamometer.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Muscular Strength
Baseline
|
3926.1 Joules
Standard Error 788.2
|
4011.0 Joules
Standard Error 833.2
|
|
Muscular Strength
Week 20
|
3999.5 Joules
Standard Error 984.3
|
4113.7 Joules
Standard Error 972.3
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
Depressive symptomatology is measured by the Center for Epidemiology Studies Depression Scale (CES-D). The total score range is 0 to 60. Higher scores represent higher levels of depressive symptomatology.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Mood
Baseline
|
5.75 score on a scale
Standard Error 0.59
|
6.05 score on a scale
Standard Error 0.66
|
|
Mood
Week 20
|
10.09 score on a scale
Standard Error 0.99
|
10.37 score on a scale
Standard Error 1.04
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
The Health Related Quality of Life (SF-36) questionnaire is being used to assess perceived quality of life, which usually improves through regular exercise. The measure is scored on a T-scale, with a mean of 50 and standard deviation of 10. Higher scores represent better functioning. Scores below 40 suggest poorer functioning than normal, and scores above 60 represent better functioning than normal.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Mental Health
Baseline
|
56.59 T-score
Standard Error 0.85
|
55.53 T-score
Standard Error 0.89
|
|
Mental Health
Week 20
|
57.27 T-score
Standard Error 0.71
|
54.41 T-score
Standard Error 1.21
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: The number analyzed differs by row because some participants did not complete the follow-up measures.
The Health Related Quality of Life (SF-36) questionnaire is being used to assess perceived quality of life, which usually improves through regular exercise. The measure is scored on a T-scale, with a mean of 50 and standard deviation of 10. Higher scores represent better functioning. Scores below 40 suggest poorer functioning than normal, and scores above 60 represent better functioning than normal.
Outcome measures
| Measure |
Control Group
n=56 Participants
We will randomly assign 56 individuals to a no exercise healthy living group.
Control Group: Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
|
Aerobic Plus Resistance Training Group
n=57 Participants
We will randomly assign 57 individuals to an aerobic plus resistance training group.
Aerobic Plus Resistance Training Group: Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
|
|---|---|---|
|
Physical Health
Week 20
|
54.96 T-score
Standard Error 0.79
|
53.4 T-score
Standard Error 1.11
|
|
Physical Health
Baseline
|
55.84 T-score
Standard Error 0.51
|
55.35 T-score
Standard Error 0.8
|
Adverse Events
Healthy Living Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Aerobic Plus Resistance Training Group
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Living Control
n=56 participants at risk
Participants assigned to the Healthy Living Group will receive health information through newsletters via email or standard mail throughout the study. They will also receive a monthly phone call from the coordinator to assess their current health status and capture any adverse events that have occurred within that month. We have found that participants assigned to these health information control groups report being satisfied with the information and their assignment. Monthly newsletters issued to participants in this group will feature such things as nutrition articles, healthy recipes, and diabetes education. We will focus heavily on diabetes education and prevention. Participants will be asked to complete satisfaction surveys throughout the intervention. After the five month intervention is complete, participants will be given a 5 month membership to the YMCA. Attendance to the YMCA will be verified via card scan reports throughout the duration of the study.
|
Aerobic Plus Resistance Training Group
n=57 participants at risk
Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of an additional 20-30 minutes of resistance training. The intervention lasts 5 months. The resistance training regimen will remain constant at 2 days per week, for 20-30 minutes, regardless of the number of days of aerobic training. Each resistance training session will consist of 2 sets of 9 exercises with each set consisting of 10-12 repetitions. Therefore, the circuit resistance machines to be used in the study are the abdominal crunch, vertical chest press, shoulder press, leg press, leg extension, and leg curl. Resistance will be increased when an individual can comfortably perform 10 repetitions of the exercise.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Illness
|
0.00%
0/56
|
1.8%
1/57
|
Other adverse events
| Measure |
Healthy Living Control
n=56 participants at risk
Participants assigned to the Healthy Living Group will receive health information through newsletters via email or standard mail throughout the study. They will also receive a monthly phone call from the coordinator to assess their current health status and capture any adverse events that have occurred within that month. We have found that participants assigned to these health information control groups report being satisfied with the information and their assignment. Monthly newsletters issued to participants in this group will feature such things as nutrition articles, healthy recipes, and diabetes education. We will focus heavily on diabetes education and prevention. Participants will be asked to complete satisfaction surveys throughout the intervention. After the five month intervention is complete, participants will be given a 5 month membership to the YMCA. Attendance to the YMCA will be verified via card scan reports throughout the duration of the study.
|
Aerobic Plus Resistance Training Group
n=57 participants at risk
Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of an additional 20-30 minutes of resistance training. The intervention lasts 5 months. The resistance training regimen will remain constant at 2 days per week, for 20-30 minutes, regardless of the number of days of aerobic training. Each resistance training session will consist of 2 sets of 9 exercises with each set consisting of 10-12 repetitions. Therefore, the circuit resistance machines to be used in the study are the abdominal crunch, vertical chest press, shoulder press, leg press, leg extension, and leg curl. Resistance will be increased when an individual can comfortably perform 10 repetitions of the exercise.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle/Joint/Injury
|
0.00%
0/56
|
1.8%
1/57
|
|
General disorders
Abnormal lab values
|
1.8%
1/56
|
0.00%
0/57
|
|
Hepatobiliary disorders
Muscle/Joint/Injury
|
1.8%
1/56
|
0.00%
0/57
|
|
Renal and urinary disorders
Muscle/Joint/Injury
|
0.00%
0/56
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Surgery/hospitalization
|
0.00%
0/56
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Abnormal lab values
|
0.00%
0/56
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
GI
|
0.00%
0/56
|
1.8%
1/57
|
|
Gastrointestinal disorders
Illness
|
0.00%
0/56
|
1.8%
1/57
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/56
|
1.8%
1/57
|
|
Nervous system disorders
Surgery/hospitalization
|
0.00%
0/56
|
1.8%
1/57
|
|
General disorders
Muscle/Joint/Injury
|
0.00%
0/56
|
1.8%
1/57
|
Additional Information
Dr. Robert Newton
Pennington Biomedical Research Center
Phone: 225-763-3034
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place