|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00954694 |
|
Date of registration:
|
05/08/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Analysis of the NuStep as an Introductory Fitness Regimen
|
|
Scientific 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 |
|
Date of first enrolment:
|
August 2009 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00954694 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Kristina L Volkmer, MPH |
|
Address:
|
|
|
Telephone:
|
402-552-3936 |
|
Email:
|
kvolkmer@nebraskamed.com |
|
Affiliation:
|
|
|
|
Name:
|
Kristina L Volkmer, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Nebraska Medical Center |
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes
|
|
Inactivity
|
|
Intervention(s)
|
|
Device: NuStep fitness apparatus
|
|
Primary Outcome(s)
|
|
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.
[Time Frame: 15 weeks]
|
|
Secondary Outcome(s)
|
|
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.
[Time Frame: 15 weeks]
|
|
Secondary ID(s)
|
|
328-09-FB
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|