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

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2	Behavioral: Exercise counseling Behavioral: Supervised exercise training

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of Central Arkansas:

Primary Outcome Measures:

Stage of Exercise Behavior [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Exercise counseling 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.	Behavioral: Exercise counseling 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.
Active Comparator: Supervised exercise training 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.	Behavioral: Supervised exercise training 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.

Arms

Assigned Interventions

Experimental: Exercise counseling

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.

Behavioral: Exercise counseling

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.

Active Comparator: Supervised exercise training

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.

Behavioral: Supervised exercise training

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910507

Locations

United States, Arkansas
University of Central Arkansas
Conway, Arkansas, United States, 72035

Sponsors and Collaborators

University of Central Arkansas

Investigators

Principal Investigator:

James D Taylor, PT, PhD

University of Central Arkansas

More Information

No publications provided

Responsible Party:	James David Taylor, PT, PhD (Principal Investigator), University of Central Arkansas
ClinicalTrials.gov Identifier:	NCT00910507 History of Changes
Other Study ID Numbers:	UCA IRB 07-070
Study First Received:	May 28, 2009
Last Updated:	May 28, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Central Arkansas:

Diabetes Mellitus, Type 2
Exercise
Counseling
Behavior

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013