Asthma, Bronchial Clinical Trial
Official title:
The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
Exercise has been shown to have extensive health benefits both in normally functioning adults as well as in adults with asthma. A program of regular aquatic exercise may have unique benefits in the asthmatic population because of the known aerobic capacity development typical of such programs, combined with the unique value of immersion-produced improvements in respiratory endurance and cardiac output. The purpose of this study is to explore the effects of a 12 week long aquatic endurance training program on several physiological and psychological parameters related to coronary heart disease and type II diabetes in an asthmatic population.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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