NCT02827383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

July 5, 2016

Last Update Submit

October 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Heart Rate

    2 Intervention Days

Study Arms (2)

Stair Climbing 4x/day

EXPERIMENTAL

Participants use the stair climber 4 times per day, for 4 minutes at a time. Total dose = 16 minutes.

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.

Behavioral: Stair Climbing Frequency

Interventions

Includes 1 sedentary day prior to completing crossover phases.

Stair Climbing 4x/dayStair Climbing 8x/day

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Research Unit, University of Georgia

Athens, Georgia, 30602, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jennifer L Gay, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations