Pilot Stair Climbing Study
Primary Purpose
Prediabetic State
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stair Climbing Frequency
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetic State
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Clinical and Translational Research Unit, University of Georgia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stair Climbing 4x/day
Stair Climbing 8x/day
Arm Description
Participants use the stair climber 4 times per day, for 4 minutes at a time. Total dose = 16 minutes.
Participants use the stair climber 8 times per day, for 2 minutes at a time. Total dose = 16 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02827383
First Posted
July 5, 2016
Last Updated
October 24, 2016
Sponsor
Jennifer Gay
Collaborators
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT02827383
Brief Title
Pilot Stair Climbing 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Gay
Collaborators
University of Illinois at Urbana-Champaign
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stair Climbing 4x/day
Arm Type
Experimental
Arm Description
Participants use the stair climber 4 times per day, for 4 minutes at a time. Total dose = 16 minutes.
Arm Title
Stair Climbing 8x/day
Arm Type
Experimental
Arm Description
Participants use the stair climber 8 times per day, for 2 minutes at a time. Total dose = 16 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Stair Climbing Frequency
Intervention Description
Includes 1 sedentary day prior to completing crossover phases.
Primary Outcome Measure Information:
Title
Continuous Glucose Monitor
Description
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.
Time Frame
Up to 5 days
Secondary Outcome Measure Information:
Title
Heart Rate
Description
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.
Time Frame
2 Intervention Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Gay, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Research Unit, University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
29746878
Citation
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.
Results Reference
derived
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Pilot Stair Climbing Study
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