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

Asthma, Bronchial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825903
• Other study ID #: 10460
• Status: Completed
• Phase: N/A
• First received: January 16, 2009
• Last updated: December 31, 2011
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: December 2011
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial

Intervention

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

Locations

Country	Name	City	State
United States	Washington State University	Pullman	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function		baseline and 12 weeks post	No
Secondary	Demographic information		baseline	No
Secondary	Medical history		baseline	No
Secondary	Smoking practices		baseline	No
Secondary	Exercise practices		baseline and monthly	No
Secondary	State Anxiety		baseline and 12 weeks post	No
Secondary	Perceived Stress		baseline and 12 weeks post	No
Secondary	Depression		baseline and 12 weeks post	No
Secondary	Sleep - duration and quality		baseline and 12 weeks post	No
Secondary	Quality of Life as related to asthma		baseline and 12 weeks post	No
Secondary	Body composition		baseline and 12 weeks post	No
Secondary	Cardiovascular fitness level- VO2 max		baseline and 12 weeks post	No
Secondary	Resting Heart Rate		baseline and 12 weeks post	No
Secondary	Heart Rate Variability and ECG		baseline and 12 weeks post	No
Secondary	Serum cholesterol levels		baseline and 12 weeks post	No
Secondary	Fasting blood glucose		baseline and 12 weeks post	No
Secondary	Cortisol		baseline and 12 weeks post	No
Secondary	Insulin		baseline and 12 weeks post	No
Secondary	CRP		baseline and 12 weeks post	No
Secondary	Homocysteine		baseline and 12 weeks post	No
Secondary	Lipoprotein-Associated Phospholipase A2 (PLAC)		baseline and 12 weeks post	No
Secondary	Medication usage		prior and throughout study	No
Secondary	Exercise Adherence		throughout study	No
Secondary	Resting blood pressure		baseline and 12 weeks post	No