What Makes Exercise Feel More Difficult to Women With and Without Type 2 Diabetes (ExPRESS)
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|ClinicalTrials.gov Identifier: NCT00785005|
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : April 19, 2012
Given that sedentary behavior is associated with T2DM, the purpose of this study is to evaluate whether subjects with T2DM have a significant disincentive to performing exercise (due to greater perceived effort) . This study will prospectively compare the perceived exercise effort between T2DM and non-diabetic women while adjusting for potential confounders including baseline physical activity. This study will also assess whether perception of effort is associated with physiologic parameters related to exercise effort. Finally, we have 3 hypothesis-generating exploratory aims designed to screen for additional psychological and physiologic parameters that may increase perceived effort in those with T2DM.
Hypothesis 1: At the same absolute workload (e.g., 30 watts) and the same relative workloads, it is a greater effort for women with T2DM to exercise than for non-diabetic women.
Specific Aim 1: To determine differences in subjective perceived effort of bicycle exercise at low-to-moderate workloads in sedentary women with Type 2 Diabetes Mellitus (T2DM) vs. non-diabetic sedentary women.
Hypothesis 2: There will be a significant association between RPE and the physiologic measures related to work intensity (e.g., relative work intensity and tau2).
Specific Aim 2: In the same populations as SA1, to determine the strength of association during bicycle exercise between subjective perceived effort and physiologic measures related to work intensity.
Exploratory Aim 1: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and additional physiologic measures
Exploratory Aim 2: In the T2DM group described in SA1, to determine the strength of association during bicycle exercise between subjective effort and psychologic measures related to perception of effort.
|Condition or disease|
|Type 2 Diabetes|
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||Exercise-related Perceived Rate of Exertion at Steady-State Workloads (ExPRESS) in Type 2 Diabetes Mellitus|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Females with Type 2 Diabetes
Females without Type 2 Diabetes
During the first visit, blood will be drawn for measurements of overall health (complete blood count and comprehensive metabolic panel), glucose and insulin levels, lipid levels, plasma FSH concentration, and HbA1C.
On two separate visits, blood samples will be drawn from a warmed IV site to measure muscle metabolites which change with exercise (e.g., glucose, calcium, lactate, H+, K+, and HCO3-) and may be associated with muscle pain or fatigue.
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): NCT00785005
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Amy Huebschmann, MD||University of Colorado, Denver|