Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss
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|ClinicalTrials.gov Identifier: NCT03035149|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : March 5, 2018
Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the effects of weight loss on dyspnea are not completely understood. The objectives of this study were to examine the relationships between exercise parameters and dyspnea in obesity and assess the effects of weight loss.
The investigators compared pulmonary function, exercise performance and dyspnea in 34 patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched controls. The study also assessed within-group changes in physiology and symptoms in a subset of patients following participation in a weight management program.
Because obesity is a heterogeneous condition, with variable genetic associations, co-morbidities and distributions of adipose tissue, the study focused on patients with abdominal obesity who met diagnostic criteria for metabolic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Metabolic Syndrome||Other: Weight Management Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Experimental: Weight Management Program
Obese subjects participate in a year long medically supervised weight management program.
Other: Weight Management Program
Obese subjects partake in a medically supervised weight management program. This lifestyle modification program involves weekly three hour sessions for six months and monthly sessions for six months. The first twelve weeks comprise an initial weight loss phase when patients are placed on a 900 Kcal/day meal replacement. This is followed by a four week transition to a 1200-1800 Kcal diet followed by a ten week maintenance phase of 10 weekly sessions.The majority of weight loss occurs during the first 26 weeks followed by a 26 week period of stabilization of weight loss. Hence subjects are evaluated after the first 26 weeks.
No Intervention: Normal Weight Controls
Normal weight age and sex-matched controls. Unlike the obese subjects, the controls did not participate in the Weight Management Program. Pulmonary function, exercise performance and dyspnea results for normal weight controls were compared against the results for obese subjects.
- Dyspnea (measured by Transitional Dyspnea Index) [ Time Frame: Within 6 months following completion of 6 months (weight loss period) in the weight management program ]Dyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index
- Resting Inspiratory Capacity (L) [ Time Frame: Within 6 months following completion of 6 months (weight loss period) in the weight management program ]Inspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest
- Inspiratory Capacity during Exercise (L) [ Time Frame: Within 6 months following completion of 6 month (weight loss period) in the weight management program ]Inspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss
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): NCT03035149
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Nha Voduc, MD||University of Ottawa|