Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2006 | ||||
| Last Updated Date | June 3, 2011 | ||||
| Start Date ICMJE | September 1995 | ||||
| Primary Completion Date | January 1998 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Insulin sensitivity | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00283673 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age | ||||
| Official Title ICMJE | Impact of Aerobic Exercise Training on Age Related Changes in Insulin Sensitivity and Muscle Oxidative Capacity | ||||
| Brief Summary | This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised exercise versus no exercise. Several end points were evaluated after 16 weeks including insulin sensitivity and muscle physiology. |
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| Detailed Description | Healthy subjects performing < 30 min exercise twice per week were studied prior to randomization and after of sixteen weeks exercise. They were randomized to sixteen weeks of supervised exercise performed on a stationary bike vs. placebo exercise (a series of flexibility exercises performed at home). Intensity, duration and frequency of exercise were gradually increased to four sessions per week lasting forty minutes each and achieving 80% target heart rate. Participants were weighed perioidically and counseled appropriately when weight changed by > 2 %. Insulin sensitivity and muscle mitochondrial protein synthesis were studied. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
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| Condition ICMJE | Aging | ||||
| Intervention ICMJE | Behavioral: Exercise | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Short KR, Vittone JL, Bigelow ML, Proctor DN, Rizza RA, Coenen-Schimke JM, Nair KS. Impact of aerobic exercise training on age-related changes in insulin sensitivity and muscle oxidative capacity. Diabetes. 2003 Aug;52(8):1888-96. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 102 | ||||
| Completion Date | January 1998 | ||||
| Primary Completion Date | January 1998 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Healthy subjects performing < 30 min exercise twice per week. Age 20-90 years. Willing to be randomized to exercise versus no exercise. Willing to be studied in General Clinical Research Center with studies including Muscle Biopsy. |
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| Gender | Both | ||||
| Ages | 20 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00283673 | ||||
| Other Study ID Numbers ICMJE | 350-95, RO1AG09531 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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