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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02827383
Other study ID # ID#STUDY00002685
Secondary ID
Status Completed
Phase N/A
First received July 5, 2016
Last updated October 24, 2016
Start date February 2016
Est. completion date September 2016

Study information

Verified date October 2016
Source University of Georgia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 64 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Stair Climbing Frequency
Includes 1 sedentary day prior to completing crossover phases.

Locations

Country Name City State
United States Clinical and Translational Research Unit, University of Georgia Athens Georgia

Sponsors (2)

Lead Sponsor Collaborator
Jennifer Gay University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 5 days No
Secondary 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. 2 Intervention Days No
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