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.

Study Overview

• Status: Completed
• Conditions: Asthma, Bronchial
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

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
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Pullman, Washington, United States, 99164
      • Washington State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Aquatic based exercise	Behavioral: Exercise; Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pulmonary Function	baseline and 12 weeks post

Secondary Outcome Measures

Outcome Measure	Time Frame
Medical history	baseline
Demographic information	baseline
Smoking practices	baseline
Exercise practices	baseline and monthly
State Anxiety	baseline and 12 weeks post
Perceived Stress	baseline and 12 weeks post
Depression	baseline and 12 weeks post
Sleep - duration and quality	baseline and 12 weeks post
Quality of Life as related to asthma	baseline and 12 weeks post
Body composition	baseline and 12 weeks post
Cardiovascular fitness level- VO2 max	baseline and 12 weeks post
Resting Heart Rate	baseline and 12 weeks post
Heart Rate Variability and ECG	baseline and 12 weeks post
Serum cholesterol levels	baseline and 12 weeks post
Fasting blood glucose	baseline and 12 weeks post
Cortisol	baseline and 12 weeks post
Insulin	baseline and 12 weeks post
CRP	baseline and 12 weeks post
Homocysteine	baseline and 12 weeks post
Lipoprotein-Associated Phospholipase A2 (PLAC)	baseline and 12 weeks post
Medication usage	prior and throughout study
Exercise Adherence	throughout study
Resting blood pressure	baseline and 12 weeks post

Collaborators and Investigators

• Sponsor: Washington State University
• Investigators: Principal Investigator: Kasee J Hildenbrand, PhD, Washington State University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: January 16, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Estimate): January 4, 2012
• Last Update Submitted That Met QC Criteria: December 31, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: asthma; aquatic exercise
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 10460