Pilot Stair Climbing Study

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.

Study Overview

• Status: Completed
• Conditions: Prediabetic State
• Intervention / Treatment: Behavioral: Stair Climbing Frequency

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30602
      • Clinical and Translational Research Unit, University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stair Climbing 4x/day; Participants use the stair climber 4 times per day, for 4 minutes at a time. Total dose = 16 minutes.	Behavioral: Stair Climbing Frequency; Includes 1 sedentary day prior to completing crossover phases.
Experimental: Stair Climbing 8x/day; Participants use the stair climber 8 times per day, for 2 minutes at a time. Total dose = 16 minutes.	Behavioral: Stair Climbing Frequency; Includes 1 sedentary day prior to completing crossover phases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jennifer Gay
• Collaborators: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Jennifer L Gay, PhD, University of Georgia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: ID#STUDY00002685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.