Prediabetic StateNCT02827383
Pilot Stair Climbing Study
A study testing Stair Climbing Frequency in people with Prediabetic State, run by Jennifer Gay at 1 site in United States.
Trial summary
This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate potential for effect of fractionalized bouts of stair climbing on glucose control in adults at risk for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Stair Climbing Frequency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Sep 2016
- 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 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age greater than 40 years but less than 65 years (working age adult with reduce physiologic capacity to regulate glucose)
- BMI of overweight or obese (25.0 to 35.0)
- Answered "No" to all questions on the Physical Activity Readiness Questionnaire, or has physician approval to participate
- Hemoglobin A1C% value in the at-risk range of 5.7 to 6.4
Who cannot join
- Unable to physically perform stair climbing
- Currently exercising for 60 or more minutes weekly.
- Weight over 275 lbs (because stair climbing machine has a weight limit)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Unit, University of Georgia
Athens, Georgia, 30602
About this study
Official title: Pilot Study to Test the Effect of Fractionalized Vigorous-Intensity Activity on Acute Glucose in Adults at Risk for Type 2 Diabetes
This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate potential for effect of fractionalized bouts of stair climbing on glucose control in adults at risk for type 2 diabetes.
Read the detailed description
Objective: Compare the short-term effects of two different fractionalized stair climbing bout protocols on glucose control among adults at risk for type 2 diabetes.
Rationale: Fractionalized physical activity is associated with reduced BMI, glycated hemoglobin, lower 2-hr plasma glucose and insulin sensitivity in cross-sectional studies. Yet, few studies have examined the effects of fractionalized or intermittent physical activity in a prospective manner. Furthermore, the research is limited to patients with diagnosed type 2 diabetes, or using exercise of a moderate intensity.
The hypothesis is that stair climbing, a vigorous-intensity activity, may have a greater health effect. However, this has not been tested in short bouts of activity that are spread out during a day.
Implications: Fractionalized physical activity may be more feasible for adults at risk for, or with diagnosed type 2 diabetes who are not currently active. These short bouts can increase energy expenditure throughout the day, rather than in one long continuous bout as currently recommended.
- Conditions
- Prediabetic State
- Being tested
- Stair Climbing Frequency
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stair Climbing FrequencyBehavioural
Includes 1 sedentary day prior to completing crossover phases.
| Study group | Role | What they receive |
|---|---|---|
| Stair Climbing 4x/day | Experimental | Participants use the stair climber 4 times per day, for 4 minutes at a time. Total dose = 16 minutes. Receives: Behavioral: Stair Climbing Frequency |
| Stair Climbing 8x/day | Experimental | Participants use the stair climber 8 times per day, for 2 minutes at a time. Total dose = 16 minutes. Receives: Behavioral: Stair Climbing Frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitor
Participant has device inserted prior to dinner the night before the sedentary day, completes the sedentary day and two stair climbing days, then has the device removed on the morning of the 5th day.
Measured: Up to 5 days
Secondary outcomes (1)
Heart Rate
Measuring heart rate during stair climbing for % max heart rate and % heart rate reserve. Heart rate will be measured during the stair climbing bouts on each of the two intervention days.
Measured: 2 Intervention Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionSep 2016
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 Prediabetic StateStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Gay
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor-investigator, Jennifer Gay, University of Georgia
- Investigators
- Jennifer L Gay, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827383
- Sponsor's protocol ID
- ID#STUDY00002685
- Status last verified
- Oct 2016
- First submitted
- 5 Jul 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: It is the investigator's intent to make data available after publication of the primary research questions. The method by which data will be made available is yet to be determined.
Publications
Gay JL, Buchner DM, Erickson ML, Lauture A. Effect of short bouts of high intensity activity on glucose among adults with prediabetes: A pilot randomized crossover study. Diabetes Res Clin Pract. 2018 Jul;141:168-174. doi: 10.1016/j.diabres.2018.04.045. Epub 2018 May 7.
PubMed 29746878
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Test the Effect of Fractionalized Vigorous-Intensity Activity on Acute Glucose in Adults at Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02827383
- Acronym / sponsor ID
- ID#STUDY00002685
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jennifer GayUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Jul 2016 (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.
This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate potential for effect of fractionalized bouts of stair climbing on glucose control in adults at risk for type 2 diabetes.
Detailed description
Objective: Compare the short-term effects of two different fractionalized stair climbing bout protocols on glucose control among adults at risk for type 2 diabetes.
Rationale: Fractionalized physical activity is associated with reduced BMI, glycated hemoglobin, lower 2-hr plasma glucose and insulin sensitivity in cross-sectional studies. Yet, few studies have examined the effects of fractionalized or intermittent physical activity in a prospective manner. Furthermore, the research is limited to patients with diagnosed type 2 diabetes, or using exercise of a moderate intensity.
The hypothesis is that stair climbing, a vigorous-intensity activity, may have a greater health effect. However, this has not been tested in short bouts of activity that are spread out during a day.
Implications: Fractionalized physical activity may be more feasible for adults at risk for, or with diagnosed type 2 diabetes who are not currently active. These short bouts can increase energy expenditure throughout the day, rather than in one long continuous bout as currently recommended.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stair Climbing 4x/day | Experimental | Behavioral: Stair Climbing FrequencyParticipants use the stair climber 4 times per day, for 4 minutes at a time. Total dose = 16 minutes. |
| Stair Climbing 8x/day | Experimental | Behavioral: Stair Climbing FrequencyParticipants use the stair climber 8 times per day, for 2 minutes at a time. Total dose = 16 minutes. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age greater than 40 years but less than 65 years (working age adult with reduce physiologic capacity to regulate glucose)
- BMI of overweight or obese (25.0 to 35.0)
- Answered "No" to all questions on the Physical Activity Readiness Questionnaire, or has physician approval to participate
- Hemoglobin A1C% value in the at-risk range of 5.7 to 6.4
Key exclusion criteria (3 listed)
- Unable to physically perform stair climbing
- Currently exercising for 60 or more minutes weekly.
- Weight over 275 lbs (because stair climbing machine has a weight limit)
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 |
|---|---|---|
| Stair Climbing FrequencyIncludes 1 sedentary day prior to completing crossover phases. | Behavioural | Stair Climbing 4x/day, Stair Climbing 8x/day |
Primary outcome
Continuous Glucose Monitor
Time frame: Up to 5 days
Participant has device inserted prior to dinner the night before the sedentary day, completes the sedentary day and two stair climbing days, then has the device removed on the morning of the 5th day.
1 secondary outcome
Heart Rate
Time frame: 2 Intervention Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 29746878Gay JL, Buchner DM, Erickson ML, Lauture A. Effect of short bouts of high intensity activity on glucose among adults with prediabetes: A pilot randomized crossover study. Diabetes Res Clin Pract. 2018 Jul;141:168-174. doi: 10.1016/j.diabres.2018.04.045. Epub 2018 May 7.
- Individual participant dataSharing planned: Undecided. It is the investigator's intent to make data available after publication of the primary research questions. The method by which data will be made available is yet to be determined.
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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.
Jennifer L Gay, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stair Climbing Frequency in people with Prediabetic State, run by Jennifer Gay 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Glucose Monitor (time frame: Up to 5 days). 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 NCT02827383, 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 25 Oct 2016.