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

31 december 2011 bijgewerkt door: Kasee Hildenbrand, Washington State University
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.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

16

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Washington
      • Pullman, Washington, Verenigde Staten, 99164
        • Washington State University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 1
Aquatic based exercise
Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Pulmonary Function
Tijdsspanne: baseline and 12 weeks post
baseline and 12 weeks post

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Kasee J Hildenbrand, PhD, Washington State University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2008

Primaire voltooiing (Werkelijk)

1 mei 2009

Studie voltooiing (Werkelijk)

1 augustus 2009

Studieregistratiedata

Eerst ingediend

16 januari 2009

Eerst ingediend dat voldeed aan de QC-criteria

16 januari 2009

Eerst geplaatst (Schatting)

21 januari 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

4 januari 2012

Laatste update ingediend die voldeed aan QC-criteria

31 december 2011

Laatst geverifieerd

1 december 2011

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Abonneren