Pilot Stair Climbing Study

Prediabetic State Clinical Trial

Official title:

Pilot Study to Test the Effect of Fractionalized Vigorous-Intensity Activity on Acute Glucose in Adults at Risk for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827383
• Other study ID #: ID#STUDY00002685
• 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

• Prediabetic State

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