The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00825903|
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : January 4, 2012
|Condition or disease||Intervention/treatment|
|Asthma, Bronchial||Behavioral: Exercise|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population|
|Study Start Date :||September 2008|
|Primary Completion Date :||May 2009|
|Study Completion Date :||August 2009|
Aquatic based exercise
Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.
- Pulmonary Function [ Time Frame: baseline and 12 weeks post ]
- Demographic information [ Time Frame: baseline ]
- Medical history [ Time Frame: baseline ]
- Smoking practices [ Time Frame: baseline ]
- Exercise practices [ Time Frame: baseline and monthly ]
- State Anxiety [ Time Frame: baseline and 12 weeks post ]
- Perceived Stress [ Time Frame: baseline and 12 weeks post ]
- Depression [ Time Frame: baseline and 12 weeks post ]
- Sleep - duration and quality [ Time Frame: baseline and 12 weeks post ]
- Quality of Life as related to asthma [ Time Frame: baseline and 12 weeks post ]
- Body composition [ Time Frame: baseline and 12 weeks post ]
- Cardiovascular fitness level- VO2 max [ Time Frame: baseline and 12 weeks post ]
- Resting Heart Rate [ Time Frame: baseline and 12 weeks post ]
- Heart Rate Variability and ECG [ Time Frame: baseline and 12 weeks post ]
- Serum cholesterol levels [ Time Frame: baseline and 12 weeks post ]
- Fasting blood glucose [ Time Frame: baseline and 12 weeks post ]
- Cortisol [ Time Frame: baseline and 12 weeks post ]
- Insulin [ Time Frame: baseline and 12 weeks post ]
- CRP [ Time Frame: baseline and 12 weeks post ]
- Homocysteine [ Time Frame: baseline and 12 weeks post ]
- Lipoprotein-Associated Phospholipase A2 (PLAC) [ Time Frame: baseline and 12 weeks post ]
- Medication usage [ Time Frame: prior and throughout study ]
- Exercise Adherence [ Time Frame: throughout study ]
- Resting blood pressure [ Time Frame: baseline and 12 weeks post ]
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): NCT00825903
|United States, Washington|
|Washington State University|
|Pullman, Washington, United States, 99164|
|Principal Investigator:||Kasee J Hildenbrand, PhD||Washington State University|