The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Sep 2007
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
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
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedJune 1, 2009
May 1, 2009
10 months
May 28, 2009
May 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stage of Exercise Behavior
2 months
Study Arms (2)
Exercise counseling
EXPERIMENTALEach 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.
Supervised exercise training
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Consider medically stable to participate by a physician
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Central Arkansas
Conway, Arkansas, 72035, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D Taylor, PT, PhD
University of Central Arkansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 1, 2009
Study Start
September 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 1, 2009
Record last verified: 2009-05