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Completed

NCT Number: NCT00825903

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington State University

Pullman, Washington, 99164, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.

Primary outcomes

  1. Pulmonary Function

    Time frame: baseline and 12 weeks post

Secondary outcomes

  1. Demographic information

    Time frame: baseline

  2. Medical history

    Time frame: baseline

  3. Smoking practices

    Time frame: baseline

  4. Exercise practices

    Time frame: baseline and monthly

  5. State Anxiety

    Time frame: baseline and 12 weeks post

  6. Perceived Stress

    Time frame: baseline and 12 weeks post

  7. Depression

    Time frame: baseline and 12 weeks post

  8. Sleep - duration and quality

    Time frame: baseline and 12 weeks post

  9. Quality of Life as related to asthma

    Time frame: baseline and 12 weeks post

  10. Body composition

    Time frame: baseline and 12 weeks post

  11. Cardiovascular fitness level- VO2 max

    Time frame: baseline and 12 weeks post

  12. Resting Heart Rate

    Time frame: baseline and 12 weeks post

  13. Heart Rate Variability and ECG

    Time frame: baseline and 12 weeks post

  14. Serum cholesterol levels

    Time frame: baseline and 12 weeks post

  15. Fasting blood glucose

    Time frame: baseline and 12 weeks post

  16. Cortisol

    Time frame: baseline and 12 weeks post

  17. Insulin

    Time frame: baseline and 12 weeks post

  18. CRP

    Time frame: baseline and 12 weeks post

  19. Homocysteine

    Time frame: baseline and 12 weeks post

  20. Lipoprotein-Associated Phospholipase A2 (PLAC)

    Time frame: baseline and 12 weeks post

  21. Medication usage

    Time frame: prior and throughout study

  22. Exercise Adherence

    Time frame: throughout study

  23. Resting blood pressure

    Time frame: baseline and 12 weeks post

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 21, 2009
Registry last updated
Jan 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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