The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
研究概览
详细说明
The study will run from August 2008 to May 2009. Recruitment and screening of participants will occur from August to December 2008 for inclusion into the clinical trial. Prior to the clinical trial participants will have a one hour informational session to clearly present the study, obtain signed informed consent and set up fitness/blood appointments for data collection. Data collection will begin the first week of school in January. The 12-week exercise protocol will start the second week of school and continue through the middle of April. Research participants will not have any exercise session during spring break (March 16-20). Final data collection will occur during the last two weeks of school. Pre-treatment and post-treatment data collection will include a fitness assessment and blood draw. Medication usage for asthma will be monitored on a weekly basis thoughout the clinical trial. Physical activity will also be monitored monthly.
The screening session is a 30-minute session where research participants complete health/behavior questionnaires and a physiological measure of lung function. Information to be collected in the health/behavior questionnaires includes: demographic and behavioral/lifestyle variables (sex, race, age, smoking status, and medical history).
The fitness assessment will be 60 minutes in length. At the beginning of the session participants will complete a survey to assess state anxiety (State-Trait Anxiety Inventory - Trait version Form X-1; Spielberger, Gorsuch, & Lushene, 1970). Heart rate variability will be measured through the ventral placement of 3 electrodes placed on the subject's torso. The areas will be prepped by swabbing with alcohol and lightly scrubbing to remove dead skin. The electrodes will be held in place with a sticky disc and a strip of athletic tape. Heart rate and resting blood pressure will also be taken. Body composition will be assessed using the BodPod system. Research participants will sit in an enclosed capsule (bod pod) for three tests lasting approximately 40 seconds each. Lung function will be assessed using a spirometer to measure the maximal volume of air exhaled over a period of time after a maximal inhalation. To assess cardiorespiratory fitness research participants will complete a VO2 Max test. Participants will ride a bicycle ergometer for approximately 15-20 minutes moving through stages (including a 3 minute warm-up) with progressively higher resistance levels until maximum tolerance. After termination there is a cool-down/recovery period of approximately 3-4 minutes.
The blood draw session will take approximately 30 minutes and participants will be asked to fast (no food or drink) for 12 hours prior to blood draw. Upon check-in participants will complete a series of questionnaires assessing psychological variables stress (Perceived Stress Scale-14 item version Form X-1; Cohen, Kamarck & Mermelstein, 1983), depression (Center for Epidemiological Studies - Depression Scale; Radloff, 1977), and quality of life (Asthma Impact Survey; QualityMetric Health Outcomes Solutions, Lincoln, RI). The quality and quantity of sleep will also be assessed using the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). Once questionnnaires are completed, participants will have their blood drawn by a certified phlebotomist. Three days after the blood draw particpants will be contacted by phone and questioned about current health status.
After the first week of pretreatment data collection, before the training sessions begin, research participants will undergo an explanation and training session to learn how to evaluate their own rate of perceived exertion (RPE). The water-based exercise programs are 3 times a week for 12 weeks. The exercise sessions will begin with a 10-minute warm up and end with a 5-minute cool down period. The conditioning portion of the exercise program will be shorter in duration with lower intensities at the beginning of the 12 weeks. There will be a progression to higher intensities for longer periods of time throughout the 12 weeks using recommendations from the American College of Sports Medicine. Exercise sessions will not exceed 50 minutes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Washington
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Pullman、Washington、美国、99164
- Washington State University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Medically diagnosed and medication managed asthmatics between the ages of 18-40
Exclusion Criteria:
- outside the age range of 18-40 years old, fear of water, diseases or conditions listed during screening process, or current smoker.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:1
Aquatic based exercise
|
Exercise 3 times each week for a total of 12 weeks.
Each session is 50 min.
in length.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Pulmonary Function
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
病史
大体时间:基线
|
基线
|
|
Demographic information
大体时间:baseline
|
baseline
|
|
Smoking practices
大体时间:baseline
|
baseline
|
|
Exercise practices
大体时间:baseline and monthly
|
baseline and monthly
|
|
State Anxiety
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Perceived Stress
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Depression
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Sleep - duration and quality
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Quality of Life as related to asthma
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Body composition
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Cardiovascular fitness level- VO2 max
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Resting Heart Rate
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Heart Rate Variability and ECG
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Serum cholesterol levels
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Fasting blood glucose
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Cortisol
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Insulin
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
CRP
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Homocysteine
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Lipoprotein-Associated Phospholipase A2 (PLAC)
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
|
Medication usage
大体时间:prior and throughout study
|
prior and throughout study
|
|
Exercise Adherence
大体时间:throughout study
|
throughout study
|
|
Resting blood pressure
大体时间:baseline and 12 weeks post
|
baseline and 12 weeks post
|
合作者和调查者
调查人员
- 首席研究员:Kasee J Hildenbrand, PhD、Washington State University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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