The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kasee Hildenbrand, Washington State University
ClinicalTrials.gov Identifier:
NCT00825903
First received: January 16, 2009
Last updated: December 31, 2011
Last verified: December 2011

January 16, 2009
December 31, 2011
September 2008
May 2009   (final data collection date for primary outcome measure)
Pulmonary Function [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00825903 on ClinicalTrials.gov Archive Site
  • Demographic information [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Medical history [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Smoking practices [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Exercise practices [ Time Frame: baseline and monthly ] [ Designated as safety issue: No ]
  • State Anxiety [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Perceived Stress [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Sleep - duration and quality [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Quality of Life as related to asthma [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Cardiovascular fitness level- VO2 max [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Resting Heart Rate [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Heart Rate Variability and ECG [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Serum cholesterol levels [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Fasting blood glucose [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Cortisol [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Homocysteine [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Lipoprotein-Associated Phospholipase A2 (PLAC) [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
  • Medication usage [ Time Frame: prior and throughout study ] [ Designated as safety issue: No ]
  • Exercise Adherence [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Resting blood pressure [ Time Frame: baseline and 12 weeks post ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Asthma, Bronchial
Behavioral: Exercise
Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.
Experimental: 1
Aquatic based exercise
Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00825903
10460
Yes
Kasee Hildenbrand, Washington State University
Washington State University
Not Provided
Principal Investigator: Kasee J Hildenbrand, PhD Washington State University
Washington State University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP