search
Back to results

The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise counseling
Supervised exercise training
Sponsored by
University of Central Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Exercise, Counseling, Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes
  • Consider medically stable to participate by a physician

Exclusion Criteria:

  • Contraindication for exercise testing
  • Uncontrolled hypertension
  • Proliferative retinopathy
  • Severe peripheral neuropathy
  • Nephropathy
  • Autonomic neuropathy
  • Unable to participate due to a physical impairment
  • Fasting plasma glucose greater than 250 mg/dL
  • Involved in resistance or aerobic training on 2 or more days per week

Sites / Locations

  • University of Central Arkansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise counseling

Supervised exercise training

Arm Description

Each participant in the experimental group receives exercise counseling from the same physical therapist as described in previous research. In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program. Exercise counseling is tailored to the stage of exercise behavior as described in previous literature. The experimental group is also provided access to a fitness center.

Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program. Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.

Outcomes

Primary Outcome Measures

Stage of Exercise Behavior

Secondary Outcome Measures

Full Information

First Posted
May 28, 2009
Last Updated
May 28, 2009
Sponsor
University of Central Arkansas
search

1. Study Identification

Unique Protocol Identification Number
NCT00910507
Brief Title
The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
Official Title
The Impact of Physical Therapist-Directed Exercise Counseling Combined With Fitness Center-Based Exercise Training on Stage of Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Central Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this randomized clinical trial is to investigate the impact of physical therapist-directed exercise counseling combined with fitness center-based exercise training on stage of exercise behavior in people with type 2 diabetes.
Detailed Description
Type 2 diabetes is a chronic, metabolic disease characterized by hyperglycemia resulting from insulin resistance. Research studies indicate that complications such as cardiovascular disease, peripheral vascular disease, retinopathy, and loss of physical function are associated with type 2 diabetes. Clinical management of people with type 2 diabetes consists of medical nutrition therapy, pharmacological therapy, and exercise. Exercise has been shown to improve risk factors associated with complications of type 2 diabetes such as elevated plasma glucose, elevated blood pressure, loss of muscular strength, and loss of exercise capacity. In fact, the American Diabetes Association and American College of Sports Medicine have published position statements recommending the use of exercise, specifically resistance and aerobic training, as an intervention for people with type 2 diabetes. However, 31 percent of people with type 2 diabetes have reported no regular physical activity and an additional 38 percent have reported less than recommended levels of physical activity. Therefore, interventions to promote regular exercise behavior in people with type 2 diabetes are clinically important by potentially preventing type 2 diabetes-related complications. Previous studies have investigated the impact of exercise counseling on exercise behavior in people with type 2 diabetes. However, these studies have limitations such as lack of agreement with exercise training guidelines for people with type 2 diabetes and research design flaws. This current study investigates the effect of a novel, physical therapist-directed exercise counseling combined with fitness center-based exercise training intervention on stage of exercise behavior in people with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Exercise, Counseling, Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise counseling
Arm Type
Experimental
Arm Description
Each participant in the experimental group receives exercise counseling from the same physical therapist as described in previous research. In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program. Exercise counseling is tailored to the stage of exercise behavior as described in previous literature. The experimental group is also provided access to a fitness center.
Arm Title
Supervised exercise training
Arm Type
Active Comparator
Arm Description
Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program. Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.
Intervention Type
Behavioral
Intervention Name(s)
Exercise counseling
Intervention Description
Each participant in the experimental group receives 2 months of exercise counseling from the same physical therapist as described in previous research. In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program. Exercise counseling is tailored to the stage of exercise behavior as described in previous literature. The experimental group is also provided access to a fitness center.
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise training
Intervention Description
Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program. Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.
Primary Outcome Measure Information:
Title
Stage of Exercise Behavior
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Consider medically stable to participate by a physician Exclusion Criteria: Contraindication for exercise testing Uncontrolled hypertension Proliferative retinopathy Severe peripheral neuropathy Nephropathy Autonomic neuropathy Unable to participate due to a physical impairment Fasting plasma glucose greater than 250 mg/dL Involved in resistance or aerobic training on 2 or more days per week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Taylor, PT, PhD
Organizational Affiliation
University of Central Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Arkansas
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72035
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial

We'll reach out to this number within 24 hrs