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Barriers to Physical Activity in People With Type 2 Diabetes (Rxercise)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo Attention Control
Supervised Exercise Training
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Exercise, Rate of Perceived Exertion

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Colorado, Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

An Active Comparator exercise training intervention

A Placebo Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rating of perceived exercise effort (RPE) during exercise (Borg RPE scale)
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

Serum lactate during exercise
Serum lactate is measured by the University of Colorado clinical laboratory (Units = mg/dl).

Full Information

First Posted
June 13, 2012
Last Updated
October 12, 2022
Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01701570
Brief Title
Barriers to Physical Activity in People With Type 2 Diabetes
Acronym
Rxercise
Official Title
Mediators of Perceived Exercise Effort in Type 2 Diabetes - Barriers to Physical Activity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Colorado Clinical & Translational Sciences Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Exercise, Rate of Perceived Exertion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
An Active Comparator exercise training intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
A Placebo Attention Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Attention Control
Intervention Description
The placebo attention control group will receive weekly phone calls to monitor their blood glucose levels.
Intervention Type
Other
Intervention Name(s)
Supervised Exercise Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Rating of perceived exercise effort (RPE) during exercise (Borg RPE scale)
Description
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.
Time Frame
Baseline, week 20
Secondary Outcome Measure Information:
Title
Serum lactate during exercise
Description
Serum lactate is measured by the University of Colorado clinical laboratory (Units = mg/dl).
Time Frame
Baseline, week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Huebschmann, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado, Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Barriers to Physical Activity in People With Type 2 Diabetes

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