Barriers to Physical Activity in People With Type 2 Diabetes (Rxercise)
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|ClinicalTrials.gov Identifier: NCT01701570|
Recruitment Status : Recruiting
First Posted : October 5, 2012
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Placebo Attention Control Other: Supervised Exercise Training||Not Applicable|
Exercise is a potent therapy to reduce cardiovascular mortality in Type 2 Diabetes (T2D). Although exercise is a cornerstone of treatment for T2D, people with T2D are more sedentary than similarly obese people without diabetes, for reasons that are unclear. Interventions which combined behavioral support and physical activity prescriptions successfully increased physical activity levels for people with T2D and at-risk for T2D. However, the program components which mediated increased physical activity were combined and thus the individual benefits of each component remain unknown. Given the success of these combined programs, it appears behavioral support and other psychological factors may play an important role. The study investigators are interested in the predictors of physical activity adherence in T2D as key targets for future interventions.
One likely factor which may influence physical activity adherence is perceived exercise effort. The study investigators reported, based on a small study, that perceived exercise effort is worse in people with T2D than in healthy obese controls, as measured by the Borg Rating of Perceived Exertion (RPE), even during low intensity exercise. Thus, one strategy to increase physical activity in T2D is to first identify the mediators of RPE in the proposed study and then to address them in future studies. The preliminary data suggest that likely mediators of RPE are both objective and subjective in nature. A key objective mediator of RPE is serum lactate level during exercise, which is a physiological marker of effort, and is disproportionately elevated in people with T2D vs. healthy controls. A key subjective mediator of RPE is self-efficacy, which influences the perception of exercise effort, and is disproportionately worse in people with T2D vs. healthy controls. To develop optimal physical activity interventions for people with T2D, the study investigators must understand whether RPE differences vary across the spectrum of exercise intensities (Aim 1), and the investigators must also determine the mediators of RPE across exercise intensities (Aim 2). Mediators of RPE in low-to-moderate intensity exercise are particularly important, because walking is a preferred physical activity for people with T2D.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mediators of Perceived Exercise Effort in Type 2 Diabetes - Barriers to Physical Activity|
|Actual Study Start Date :||April 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: An Active Comparator exercise training intervention
The Active Comparator Groupwill participate in an exercise training intervention to distinguish the relative roles of objective factors (lactate level) and subjective factors (self-efficacy) in mediating pre-post change in RPE during low, moderate, and vigorous exercise.
Other: Supervised Exercise Training
The 20-week aerobic exercise training intervention provides supervised exercise training sessions 3 times weekly following the HERITAGE study training model that was feasible in prior studies with older, sedentary overweight adults (55%maximal oxygen uptake (VO2max) for 30 minutes per session at study entry with progressive titration to 70-80% VO2max for 50 minutes).
Placebo Comparator: A Placebo Attention Control
The placebo attention control group will receive monthly diabetes education and phone calls phone calls to monitor their blood glucose levels. Participants will receive an accelerometer to wear for one week.
Behavioral: Placebo Attention Control
The placebo attention control group will receive weekly phone calls to monitor their blood glucose levels.
- Rating of perceived exercise effort (RPE) during exercise (Borg RPE scale) [ Time Frame: Baseline, week 20 ]RPE was developed by Dr. Gunnar Borg and is a validated, self-reported measure of perceived effort during exercise. Possible scores range from 6 (no effort, resting) to 20 (maximal effort). Change = RPE post-intervention (week 20) - RPE baseline.
- Serum lactate during exercise [ Time Frame: Baseline, week 20 ]Serum lactate is measured by the University of Colorado clinical laboratory (Units = mg/dl).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701570
|Contact: Ian Leavitt, MS||720-848-7103||Ian.Leavitt@ucdenver.edu|
|Contact: Amy Huebschmann, MDemail@example.com|
|United States, Colorado|
|University of Colorado, Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Ian M Leavitt, MS 720-848-7103 firstname.lastname@example.org|
|Principal Investigator: Amy Huebschmann, MD, MS|
|Principal Investigator:||Amy Huebschmann, MD||University of Colorado, Denver|