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Analysis of the NuStep as an Introductory Fitness Regimen

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00954694
Enrollment
30
Registered
2009-08-07
Start date
2009-08-31
Completion date
2009-11-30
Last updated
2009-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Inactivity

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.

Interventions

DEVICENuStep 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).

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Contacts

Primary ContactKristina L Volkmer, MPH
kvolkmer@nebraskamed.com402-552-3936

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026