- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00825903
The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
Aperçu de l'étude
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
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Washington
-
Pullman, Washington, États-Unis, 99164
- Washington State University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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
Parrainer
Les enquêteurs
- Chercheur principal: Kasee J Hildenbrand, PhD, Washington State University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10460
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