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

31 décembre 2011 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

16

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Washington
      • Pullman, Washington, États-Unis, 99164
        • Washington State University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 40 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 1
Aquatic based exercise
Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Pulmonary Function
Délai: baseline and 12 weeks post
baseline and 12 weeks post

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Kasee J Hildenbrand, PhD, Washington State University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2008

Achèvement primaire (Réel)

1 mai 2009

Achèvement de l'étude (Réel)

1 août 2009

Dates d'inscription aux études

Première soumission

16 janvier 2009

Première soumission répondant aux critères de contrôle qualité

16 janvier 2009

Première publication (Estimation)

21 janvier 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 janvier 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 décembre 2011

Dernière vérification

1 décembre 2011

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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