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The purpose of this study is to investigate the effect of an exercise training intervention on the ability of African American males to use insulin properly. Insulin is a hormone that helps the body use glucose.
This study is designed to assess the effect of exercise training on insulin resistance in African American males. African American males have higher rates of diabetes and lower levels of fitness when compared to Caucasian males. A project such as this is necessary because there is evidence to show that exercise training can reduce the risk of developing diabetes, though no studies have been conducted in African American males. In addition, ARTIIS will test the effect adhering to the 2008 Physical Activity Guidelines for Americans (150 minutes of moderate intensity aerobic activity and 2 days of 20 minutes of muscular strength activity), on insulin resistance in African American men. This study will provide important information that can either strengthen or refine current physical activity recommendations. Furthermore, this intervention will be delivered through community facilities in order to increase the likelihood that the intervention will be sustainable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | We will randomly assign 52 individuals to a no exercise healthy living group. |
|
| Aerobic Plus Resistance Training Group | Experimental | We will randomly assign 52 individuals to an aerobic plus resistance training group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Plus Resistance Training Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks. | 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. | Baseline, week 10, week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure | Blood pressure was measured at rest using a standard mercury sphygmomanometer. | 20 weeks |
| Systolic Blood Pressure | Blood pressure was measured at rest using a standard mercury sphygmomanometer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L. Newton, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25979318 | Background | Newton RL Jr, Johnson WD, Hendrick C, Harris M, Andrews E 3rd, Johannsen N, Rodarte RQ, Hsia DS, Church TS. A randomized controlled exercise training trial on insulin sensitivity in African American men: The ARTIIS study: Major category: study design, statistical design, study protocols. Contemp Clin Trials. 2015 Jul;43:75-82. doi: 10.1016/j.cct.2015.05.004. Epub 2015 May 12. | |
| 31939911 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks. | 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. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | uU/mL | Baseline, week 10, week 20 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Living Control | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Illness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Hospitalized overnight for a boil. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle/Joint/Injury | Musculoskeletal and connective tissue disorders | Healthy Living Group | Non-systematic Assessment | Bursitis in hip. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Newton | Pennington Biomedical Research Center | 225-763-3034 | Robert.Newton@pbrc.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Control Group | Behavioral | 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. |
|
|
| 20 weeks |
| Body Composition | Body composition was assessed using the General Electric (General Electric; Milwaukee, WI) Lunar i-Dual energy X-ray absorptiometry. | 20 weeks |
| Cardiorespiratory Fitness | 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. | 20 weeks |
| Muscular Strength | 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. | 20 weeks |
| Mood | 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. | 20 weeks |
| Mental Health | 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. | 20 weeks |
| Physical Health | 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. | 20 weeks |
| Background |
| Newton RL Jr, Johnson WD, Larrivee S, Hendrick C, Harris M, Johannsen NM, Swift DL, Hsia DS, Church TS. A Randomized Community-based Exercise Training Trial in African American Men: Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men. Med Sci Sports Exerc. 2020 Feb;52(2):408-416. doi: 10.1249/MSS.0000000000002149. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Aerobic Plus Resistance Training Group | 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. |
|
|
| Secondary | Diastolic Blood Pressure | Blood pressure was measured at rest using a standard mercury sphygmomanometer. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | mmHg | 20 weeks |
|
|
|
| Secondary | Systolic Blood Pressure | Blood pressure was measured at rest using a standard mercury sphygmomanometer. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | mm Hg | 20 weeks |
|
|
|
| Secondary | Body Composition | Body composition was assessed using the General Electric (General Electric; Milwaukee, WI) Lunar i-Dual energy X-ray absorptiometry. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | kg | 20 weeks |
|
|
|
| Secondary | Cardiorespiratory Fitness | 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. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | L/min of oxygen | 20 weeks |
|
|
|
| Secondary | Muscular Strength | 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. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | Joules | 20 weeks |
|
|
|
| Secondary | Mood | 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. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | score on a scale | 20 weeks |
|
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| Secondary | Mental Health | 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. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | T-score | 20 weeks |
|
|
|
| Secondary | Physical Health | 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. | The number analyzed differs by row because some participants did not complete the follow-up measures. | Posted | Mean | Standard Error | T-score | 20 weeks |
|
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|
| 0 |
| 56 |
| 4 |
| 56 |
| EG001 | 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 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. | 1 | 57 | 16 | 57 |
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| Muscle/Joint/Injury | Musculoskeletal and connective tissue disorders | Healthy Living Group | Non-systematic Assessment | L Achilles tear, surgical repair secondary to a fall at work. |
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| Abnormal lab values | General disorders | Non-systematic Assessment | Diagnosed with T2DM. |
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| Muscle/Joint/Injury | Hepatobiliary disorders | Non-systematic Assessment | Sprained L knee refereeing basketball game |
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| Muscle/Joint/Injury | Renal and urinary disorders | Non-systematic Assessment | Prostate resection surgery. |
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| Muscle/Joint/Injury | Renal and urinary disorders | Non-systematic Assessment | Prostate procedure (h/o BPH). |
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| Muscle/Joint/Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Muscle spasms secondary to MVA |
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| Surgery/hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Left shoulder pain. |
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| Muscle/Joint/Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Neck pain secondary to MVA. |
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| Muscle/Joint/Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Shoulder strain secondary to fall on treadmill during intervention. |
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| Abnormal lab values | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Back pain. |
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| Surgery/hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | L knee strain at work. |
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| Muscle/Joint/Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | L shoulder pain (prior history) |
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| Muscle/Joint/Injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | L shoulder pain after sleeping funny. |
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| GI | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Lower back pain & R lower extremity pain secondary to MVA. |
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| Illness | Gastrointestinal disorders | Non-systematic Assessment | Stomach pain, missed intervention for 1 week. |
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| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Abnormal thyroid test. |
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| Surgery/hospitalization | Nervous system disorders | Non-systematic Assessment | Recurrent headaches. |
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| Muscle/Joint/Injury | General disorders | Non-systematic Assessment | Flu. |
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| Muscle/Joint/Injury | General disorders | Non-systematic Assessment | Nausea & weakness during exercise (no breakfast) |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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