Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00785005
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2008-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
What Makes Exercise Feel More Difficult to Women With and Without Type 2 Diabetes
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Exercise-related Perceived Rate of Exertion at Steady-State Workloads (ExPRESS) in Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExPRESS
Brief Summary:
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 Aims:
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.
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 Aims:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: