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Asthma, BronchialNCT00825903

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

A study testing Exercise in people with Asthma, Bronchial, run by Washington State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Asthma, Bronchial
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2008to Aug 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Medically diagnosed and medication managed asthmatics between the ages of 18-40

Who cannot join

  • outside the age range of 18-40 years old, fear of water, diseases or conditions listed during screening process, or current smoker.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington State University

    Pullman, Washington, 99164

Other trials in United States

About this study

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.

Read the 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.

Being tested
Exercise
Keywords
aquatic exercise, asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

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

Study groups in NCT00825903
Study groupRoleWhat they receive
1ExperimentalAquatic based exercise
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary Function

    Measured: baseline and 12 weeks post

Secondary outcomes (23)
  1. Demographic information

    Measured: baseline

  2. Medical history

    Measured: baseline

  3. Smoking practices

    Measured: baseline

  4. Exercise practices

    Measured: baseline and monthly

  5. State Anxiety

    Measured: baseline and 12 weeks post

  6. Perceived Stress

    Measured: baseline and 12 weeks post

  7. Depression

    Measured: baseline and 12 weeks post

  8. Sleep - duration and quality

    Measured: baseline and 12 weeks post

  9. Quality of Life as related to asthma

    Measured: baseline and 12 weeks post

  10. Body composition

    Measured: baseline and 12 weeks post

  11. Cardiovascular fitness level- VO2 max

    Measured: baseline and 12 weeks post

  12. Resting Heart Rate

    Measured: baseline and 12 weeks post

  13. Heart Rate Variability and ECG

    Measured: baseline and 12 weeks post

  14. Serum cholesterol levels

    Measured: baseline and 12 weeks post

  15. Fasting blood glucose

    Measured: baseline and 12 weeks post

  16. Cortisol

    Measured: baseline and 12 weeks post

  17. Insulin

    Measured: baseline and 12 weeks post

  18. CRP

    Measured: baseline and 12 weeks post

  19. Homocysteine

    Measured: baseline and 12 weeks post

  20. Lipoprotein-Associated Phospholipase A2 (PLAC)

    Measured: baseline and 12 weeks post

  21. Medication usage

    Measured: prior and throughout study

  22. Exercise Adherence

    Measured: throughout study

  23. Resting blood pressure

    Measured: baseline and 12 weeks post

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionMay 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00825903
Sponsor's protocol ID
10460
Status last verified
Dec 2011
First submitted
16 Jan 2009
Last updated
4 Jan 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Asthma, Bronchial, run by Washington State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Function (time frame: baseline and 12 weeks post). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2012.

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