Analysis of the NuStep as an Introductory Fitness Regimen

Not Applicable

• Conditions: Diabetes; Inactivity
• Interventions: Device: NuStep fitness apparatus

• Registration Number: NCT00954694
• Lead Sponsor: University of Nebraska

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-06
• Last Update Submitted: 2009-08-06
• Study First Posted: 2009-08-07
• Last Update Posted: 2009-08-07
• Primary Completion: 2009-11
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Sedentary adults diagnosed by a physician with Type 1 diabetes or Type 2 diabetes. Sedentary adults are defined as persons 19 years of age and older that are not meeting the minimal physical activity recommendations from the U.S. Surgeon General's report.

Exclusion Criteria

• Adults with:

  • severe cardiovascular disease (high blood pressure, abnormal heart rhythm, peripheral artery disease, atherosclerosis, congestive heart failure, congenital heart disease, valvular heart disease and coronary artery disease)
  • amputees
  • severe foot ulcers
  • severe neuropathy
  • an amplified susceptibility to hypoglycemia
  • those weighing 400 lbs. or more, or inability to adequately perform exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
introductory exercise regimen	NuStep fitness apparatus	sedentary adults will be introduced to an introductory fitness regimen using the NuStep

Primary Outcome Measures

Name	Time	Method
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.	15 weeks

Secondary Outcome Measures

Name	Time	Method
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.	15 weeks

Trial Locations

Locations (1)

The Nebraska Medical Center Diabetes Center; 🇺🇸 Omaha, Nebraska, United States