DiabetesNCT00954694
Analysis of the NuStep as an Introductory Fitness Regimen
A study testing NuStep fitness apparatus in people with Diabetes and Inactivity, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Inactivity
- What is being tested?
- NuStep fitness apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Nebraska Medical Center Diabetes Center
Omaha, Nebraska, 68198-4100
About this 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
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.
- Conditions
- Diabetes, Inactivity
- Being tested
- NuStep fitness apparatus
- Medical subject headings
- Diabetes Mellitus, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| introductory exercise regimen | Experimental | sedentary adults will be introduced to an introductory fitness regimen using the NuStep Receives: Device: NuStep fitness apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Investigators
- Kristina L Volkmer, MPH, Principal investigator, The Nebraska Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954694
- Sponsor's protocol ID
- 328-09-FB
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00954694
- Acronym / sponsor ID
- 328-09-FB
- Conditions
- Diabetes, Inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| introductory exercise regimen | Experimental | Device: NuStep fitness apparatussedentary adults will be introduced to an introductory fitness regimen using the NuStep |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Adults with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuStep fitness apparatusThe 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). | Device | introductory exercise regimen |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
- BackgroundAmerican 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina L Volkmer, MPH principal investigator
The Nebraska Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuStep fitness apparatus in people with Diabetes and Inactivity, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina L Volkmer, MPH (402-552-3936, kvolkmer@nebraskamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.