NCT01417845

Brief Summary

The purpose of this randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. The research hypothesis is that high intensity exercise training will be superior to moderate intensity on such outcomes in individuals with type 2 diabetes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable type-2-diabetes

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

August 11, 2011

Last Update Submit

January 31, 2014

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Muscle Strength

    Baseline and 3 months thereafter

  • Physical Function

    Baseline and 3 months thereafter

  • Exercise Capacity

    Baseline and 3 months thereafter

Study Arms (2)

High Intensity Exercise

EXPERIMENTAL

High intensity resistance and aerobic training

Behavioral: High Intensity Exercise Training

Moderate Intensity Exercise

ACTIVE COMPARATOR

Moderate intensity resistance and aerobic training

Behavioral: Moderate Intensity Exercise Training

Interventions

High Intensity Exercise TrainingBEHAVIORAL

* High intensity resistance and aerobic training * Resistance training is performed 2 days per week for 3 months * Aerobic training is performed on the same days as resistance training and 1 additional day per week.

High Intensity Exercise
Moderate Intensity Exercise TrainingBEHAVIORAL

* Moderate intensity resistance and aerobic training * Resistance training is performed on 2 days per week for 3 months. * Aerobic training is performed on the same days as resistance training and 1 additional day per week.

Moderate Intensity Exercise

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants meet the American Diabetes Association diagnostic criteria for type 2 diabetes.
  • A physician must consider each participant to be medically stable to participate in this investigation.

You may not qualify if:

  • Any individual with a history of a medical condition identified by the American Heart Association as an absolute contraindication to exercise testing is excluded from this study.
  • Any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation.
  • Any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Arkansas

Conway, Arkansas, 72035, United States

Location

Related Publications (1)

  • Taylor JD, Fletcher JP, Mathis RA, Cade WT. Effects of moderate- versus high-intensity exercise training on physical fitness and physical function in people with type 2 diabetes: a randomized clinical trial. Phys Ther. 2014 Dec;94(12):1720-30. doi: 10.2522/ptj.20140097. Epub 2014 Jul 31.

    PMID: 25082918DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • James D Taylor, PhD, PT

    University of Central Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 16, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

US(1)