The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes

NCT ID: NCT01417845

Last Updated: 2014-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Intensity Exercise

High intensity resistance and aerobic training

Group Type EXPERIMENTAL

High Intensity Exercise Training

Intervention Type BEHAVIORAL

* 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.

Moderate Intensity Exercise

Moderate intensity resistance and aerobic training

Group Type ACTIVE_COMPARATOR

Moderate Intensity Exercise Training

Intervention Type BEHAVIORAL

* 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Intensity Exercise Training

* 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.

Intervention Type BEHAVIORAL

Moderate Intensity Exercise Training

* 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Central Arkansas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James David Taylor, PT, PhD

Associate Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James D Taylor, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Central Arkansas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Central Arkansas

Conway, Arkansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25082918 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCA-IRB-11-077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diabetes Exercise and Lifestyle Trial
NCT00877864 UNKNOWN EARLY_PHASE1