跳至主要内容
临床试验/NCT03035149
NCT03035149已完成不适用

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

University of Ottawa2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2005年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Inspiratory Capacity during Exercise (L)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Weight Management Program

Experimental

Obese subjects participate in a year long medically supervised weight management program.

干预措施: Weight Management Program (Other)

Normal Weight Controls

No Intervention

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.

结局指标

主要结局

Inspiratory Capacity during Exercise (L)

时间窗: 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

Dyspnea (measured by Transitional Dyspnea Index)

时间窗: 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)

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Nha Voduc

MD

University of Ottawa

研究点 (2)

Loading locations...

相似试验