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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 : November 24, 2017
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The investigators plan to learn more about how different levels of exercise feel to people with Type 2 Diabetes and how it feels to people without Type 2 Diabetes. This study team will also look at what causes exercise to feel harder or easier to people with and without Type 2 Diabetes. The investigators will also compare the potential benefits of supervised exercise training to that of diabetes education/blood sugar monitoring.

Condition or disease Intervention/treatment
Type 2 Diabetes Behavioral: Placebo Attention Control Other: Supervised Exercise Training

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mediators of Perceived Exercise Effort in Type 2 Diabetes - Barriers to Physical Activity
Study Start Date : April 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 25 Participants with Type 2 Diabetes 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: 25 Participant with Type 2 Diabetes Behavioral: Placebo Attention Control
The placebo attention control group will receive weekly phone calls to monitor their blood glucose levels.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Serum lactate during exercise [ Time Frame: Baseline, week 20 ]
    Serum lactate is measured by the University of Colorado clinical laboratory (Units = mg/dl).

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Sedentary men and women not participating in a regular exercise program (> 60 minutes of exercise per week)
  • If subject has diabetes,

    • must be uncomplicated type 2 diabetes (T2D) and
    • <15 years since T2D diagnosis.
  • Ages of 50-70 years
  • BMI between 25 and 35
  • Subjects can only be taking the following oral hypoglycemic drugs:

    • metformin,
    • sulfonylureas or
    • sitagliptin.
  • Persons with T2D only if they have total glycosylated hemoglobin levels (HbA1C) <8.0% (adequate control) on therapy.
  • Control subjects must have:

    • HbA1C < 5.7% and
    • a fasting blood glucose of <100 mg/dl suggesting no significant insulin resistance.
  • All women must be post-menopausal, documented by menstrual history and follicle stimulating hormone (FSH) level.
  • Those who have quit smoking for at least 1 year will be accepted.
  • Absence of comorbid conditions that could affect exercise will be confirmed by history, physical examination and laboratory testing.

Exclusion Criteria:

  • Persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.

    • Specifically, if monofilament sensation is absent at the level of the ankles, then participants will be excluded from study participation.
  • Persons with autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
  • Current use of insulin or other oral hypoglycemic medications.
  • Current smokers will be excluded since smoking can impair cardiovascular (CV) exercise performance
  • Persons will be excluded if they have:

    • evidence of heart disease by history (Prior heart attack or bypass surgery, heart failure, or significant valvular disease) or
    • abnormal resting electrocardiogram (EKG) consistent with prior infarct or latent ischemia (unless cardiovascular stress imaging or catheterization shows they do not have coronary artery disease).
    • left or right bundle branch block on resting EKG (precludes recognition of ischemic EKG changes with exercise) or
    • abnormal exercise EKG (> 1 mm ST segment depression 80 msec out in the ST segment for 3 consecutive beats).
  • Persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms.
  • Presence of:

    • systolic blood pressure >145 mm Hg at rest or >250 mm Hg with exercise or
    • diastolic blood pressure >90 mm Hg at rest or >115 mm Hg with exercise.
  • Subjects with:

    • proteinuria (urine protein >220 mg/dl) or
    • creatinine > 1.6 mg/dl, suggestive of renal disease.
  • Subjects with:

    • total cholesterol >220 mg/dl,
    • low density lipoprotein > 130 mg/dl, or
    • triglycerides > 250 mg/dl, will be excluded given the potential insulin resistance and endothelial dysfunction associated with these cholesterol parameters.
  • Control subjects who have more than two immediate family members with type 2 diabetes.
  • Chronic obstructive pulmonary disease demonstrated by a ratio of

    • Forced Expiratory Volume in 1 second (FEV1),
    • Forced Vital Capacity (FVC) < 0.70, or
    • FEV1 <70% predicted during spirometry.
  • Persons weighing more than 300 pounds will be excluded as this exceeds the weight capacity of our Dual Energy X-ray Absorptiometry device
  • Participants with moderate cognitive impairment (Folstein Mini-Mental Status Examination (MMSE) score <24).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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, MD 303-724-2268 amy.huebschmann@ucdenver.edu

United States, Colorado
University of Colorado, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Ian M Leavitt, MS    720-848-7103    ian.leavitt@ucdenver.edu   
Principal Investigator: Amy Huebschmann, MD, MS         
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
Principal Investigator: Amy Huebschmann, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01701570     History of Changes
Other Study ID Numbers: 11-0909
6147 ( Other Identifier: University of Colorado CTRC )
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by University of Colorado, Denver:
Type 2 Diabetes
Rate of Perceived Exertion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases