NCT00954694

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

3 months

First QC Date

August 5, 2009

Last Update Submit

August 6, 2009

Conditions

DiabetesInactivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

introductory exercise regimen

EXPERIMENTAL

sedentary adults will be introduced to an introductory fitness regimen using the NuStep

Device: NuStep fitness apparatus

Interventions

NuStep fitness apparatusDEVICE

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).

introductory exercise regimen

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Nebraska Medical Center Diabetes Center

Omaha, Nebraska, 68198-4100, United States

Location

Related Publications (1)

  • American Diabetes Assocation. (2002). Handbook of exercise in diabetes. Alexandria, Virginia: Transcontinental Publishing. Coquart, J.B., Lemaire, C., Dubart A.,E., Luttembacher, D.P., Douillard, C., & Garcin, M. (2008). Intermittent versus continuous exercise :Effects of perceptually lower exercise in obese women. Medicine Science Sports Exercise, 40(8);1546-53. Conn, V., Vanetine, J., & Cooper, H. (2002). Interventions to Increase Physical Activity Among Aging Adults: A Meta-Analysis. The Annuals Of Behavioral Medicine, 24(3);190-200. Donahue, M.D. (2003). Physiological responses to submaximal workload on four exercise ergometers. Kinesiology Abstracts, 16(1). Glaros, N.M., & Janeele, C.M. (2001). Varying the mode of cardiovascular exercise to increase adherence. Journal of Sport Behavior, 24(2), 42-63. Gutbrod, N., Hiniker, J., Oakes, A., & Smecko, J. (2008). Physiological responses of the NuStep for individuals with cardiovascular disease. Journal of Undergraduate Kinesiology, Vol 3(2), 60-67. McCutcheon, S. (2008), Recumbent stepper: Aerobic testing and training protocol development. Masters Abstracts International. 45(6), 2008-2009. NuStep. (2009). Retrieved May 1, 2009, from http:///www.nustep.com/product/trs4000 Patten, C., Armstrong, C., Martin, J., Sallis, J., & Booth, J. (2000). Behavioral control of exercise in adults: Studies 7 and 8. Psychology and Health, 15, 571-581. Tantiwong, P., & Musi, N. (2009) The importance of exercise. Practical diabetology, 28(2). U.S. Department of Health and Human Services Office of the Surgeon General. (2009). Retrieved April 30, 2009 from http://www.health.gov/paguidelines/guidelines/summary.aspx Wasserman, K., Hansen, J.E., & Sue, D.Y., Principles of Exercise Testing. Philadelphia : Lea & Febiger, 1987 :79.

    BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusSedentary Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Kristina L Volkmer, MPH

    The Nebraska Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina L Volkmer, MPH

CONTACT

402-552-3936kvolkmer@nebraskamed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

US(1)