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Sponsored by: |
University of Nebraska |
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Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00954694 |
The purpose of this research study is to determine if participation in a fifteen week introductory exercise regimen using the NuStep by sedentary adults diagnosed with Type 1 or Type 2 diabetes will affect exercise adherence and lifestyle adjustment. This study will examine if using the NuStep encourages participants to seek other modes and facilitates interest in exercise. Age, gender, weight, height, waist-to-hip ratio, heart rate, blood pressure, 6-minute walk test, and A1C will be recorded pre, mid-point, and post-test. During each NuStep exercise session heart rate, blood pressure, blood glucose level, oxygen saturation, METs, and the Borg rate of perceived exertion will be monitored. Associations between NuStep use and exercise adherence are investigated through the following hypothesis and null hypothesis. There is an association between using the NuStep as an introductory exercise regimen by sedentary adults diagnosed with Type 1 or Type 2 diabetes and exercise adherence. The null hypothesis states there is no association between using the NuStep as an introductory exercise regimen by sedentary adults diagnosed with Type 1 or Type 2 diabetes and exercise adherence. The primary endpoint of the study is the qualitative measurement, by use of a questionnaire, of attitude and interest toward exercise in participants by assessing if they choose to seek and perform other modes of exercise. Secondary endpoints are the quantitative measurement of the change in weight, waist-to-hip ratio, heart rate, blood pressure, 6-minute walk test, and A1C levels.
Condition | Intervention |
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Diabetes Inactivity |
Device: NuStep fitness apparatus |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Assessing the Impact of an Introductory Exercise Regimen: An Analysis of the Consequent Effects of NuStep in Relation to Physical Activity and Lifestyle Adjustment in Adults With Type 1 and Type 2 Diabetes |
Estimated Enrollment: | 30 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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introductory exercise regimen: Experimental
sedentary adults will be introduced to an introductory fitness regimen using the NuStep
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Device: NuStep fitness apparatus
The NuStep is a mode of exercise that has recently been used in clinical settings to determine appropriate intensity recommendations and energy expenditures. The NuStep exercise implement provides simultaneous upper and lower body movement while in a seated position. The machine stimulates all major muscle groups while putting minimal strain on joints. Ten resistance settings are offered and the device is fully adjustable to accommodate users of varying sizes (NuStep, 2009).
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Adults with:
Contact: Kristina L Volkmer, MPH | 402-552-3936 | kvolkmer@nebraskamed.com |
United States, Nebraska | |
The Nebraska Medical Center Diabetes Center | |
Omaha, Nebraska, United States, 68198-4100 |
Principal Investigator: | Kristina L Volkmer, MPH | The Nebraska Medical Center |
Responsible Party: | The Nebraska Medical Center Diabetes Center ( Kristina Volkmer/exercise physiologist ) |
Study ID Numbers: | 328-09-FB |
Study First Received: | August 5, 2009 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00954694 History of Changes |
Health Authority: | United States: Institutional Review Board |
Diabetes Mellitus, Type 2 Diabetes Mellitus |