Type 2 DiabetesRxerciseNCT01701570
Barriers to Physical Activity in People With Type 2 Diabetes
A study testing Supervised Exercise Training in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Supervised Exercise Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
Show all 28Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Mediators of Perceived Exercise Effort in Type 2 Diabetes - Barriers to Physical Activity
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo Attention Control, Supervised Exercise Training
- Keywords
- Type 2 Diabetes, Exercise, Rate of Perceived Exertion
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Attention ControlBehavioural
The placebo attention control group will receive weekly phone calls to monitor their blood glucose levels.
Supervised Exercise TrainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| An Active Comparator exercise training intervention | Active comparator | 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. Receives: Other: Supervised Exercise Training |
| A Placebo Attention Control | Placebo comparator | 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. Receives: Behavioral: Placebo Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 20
Secondary outcomes (1)
Serum lactate during exercise
Serum lactate is measured by the University of Colorado clinical laboratory (Units = mg/dl).
Measured: Baseline, week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Amy Huebschmann, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701570
- Sponsor's protocol ID
- 11-0909
- Other IDs
- 6147
- Acronym
- Rxercise
- Status last verified
- Oct 2022
- First submitted
- 13 Jun 2012
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediators of Perceived Exercise Effort in Type 2 Diabetes - Barriers to Physical Activity
- ClinicalTrials.gov ID
- NCT01701570
- Acronym / sponsor ID
- Rxercise / 11-0909
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Exercise, Rate of Perceived Exertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute
- Study start
- Apr 2012 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| An Active Comparator exercise training intervention | Active comparator | Other: Supervised Exercise TrainingThe 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. |
| A Placebo Attention Control | Placebo comparator | Behavioral: Placebo Attention ControlThe 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Sedentary men and women not participating in a regular exercise program (> 60 minutes of exercise per week)
- If subject has diabetes,
- Ages of 50-70 years
- BMI between 25 and 35
- Subjects can only be taking the following oral hypoglycemic drugs:
Key exclusion criteria (28 listed)
- 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.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Attention ControlThe placebo attention control group will receive weekly phone calls to monitor their blood glucose levels. | Behavioural | A Placebo Attention Control |
| Supervised Exercise TrainingThe 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). | Other | An Active Comparator exercise training intervention |
Primary outcome
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.
1 secondary outcome
Serum lactate during exercise
Time frame: Baseline, week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Huebschmann, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Training in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating of perceived exercise effort (RPE) during exercise (Borg RPE scale) (time frame: Baseline, week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.