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Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss

Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03035149
Enrollment
68
Registered
2017-01-27
Start date
2005-05-31
Completion date
2012-07-31
Last updated
2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Metabolic Syndrome

Keywords

Obesity, Metabolic Syndrome, Dyspnea, Pulmonary Function, Exercise Capacity

Brief summary

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.

Detailed description

The study has two parts: first, the investigators compared dyspnea, pulmonary function and exercise measurements between obese patients and control subjects with normal weight; then, the investigators assessed the effects of medical weight loss in the obese group on these parameters. Baseline dyspnea was assessed using the baseline dyspnea index.The effect of weight loss on dyspnea was assessed using the transitional dyspnea index. The main physiologic measurement of interest was the inspiratory capacity (L, measured at rest and during exercise).

Interventions

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.

Sponsors

Ontario Lung Association
CollaboratorOTHER
The Ottawa Hospital
CollaboratorOTHER
University of Ottawa
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Individuals accepted into the behavioural weight management program at the Ottawa Hospital Bariatric Centre * Age between 20 and 60 years * BMI greater than 30 * Abdominal girth (for females) greater than 88 cm * Abdominal girth (for males) greater than 102 cm * Plus any two of the other criteria for Metabolic Syndrome: i.e. Blood Pressure greater or equal to 130/85; Fasting Glucose greater or equal to 6.1 mmol/L * Controls-normal weight (NW) and sedentary

Exclusion criteria

* Smoker * Any medical conditions which would affect exercise performance * Use of medications that could affect exercise performance (i.e. Beta-blockers) * Inability to pedal on a cycle ergometer and provide reproducible inspiratory capacity (IC) measurements

Design outcomes

Primary

MeasureTime frameDescription
Dyspnea (measured by Transitional Dyspnea Index)Within 6 months following completion of 6 months (weight loss period) in the weight management programDyspnea was assessed using a questionnaire based on the Transitional Dyspnea Index
Resting Inspiratory Capacity (L)Within 6 months following completion of 6 months (weight loss period) in the weight management programInspiratory capacity (difference between total lung capacity and functional residual capacity), measured at rest
Inspiratory Capacity during Exercise (L)Within 6 months following completion of 6 month (weight loss period) in the weight management programInspiratory capacity measured at identical time points during incremental exercise tests, performed before and after weight loss

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026