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

31. Dezember 2011 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

16

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Washington
      • Pullman, Washington, Vereinigte Staaten, 99164
        • Washington State University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Pulmonary Function
Zeitfenster: baseline and 12 weeks post
baseline and 12 weeks post

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2008

Primärer Abschluss (Tatsächlich)

1. Mai 2009

Studienabschluss (Tatsächlich)

1. August 2009

Studienanmeldedaten

Zuerst eingereicht

16. Januar 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Januar 2009

Zuerst gepostet (Schätzen)

21. Januar 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

4. Januar 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Dezember 2011

Zuletzt verifiziert

1. Dezember 2011

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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