- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01626131
Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder
Exercise: A Novel Treatment for Combat PTSD
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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South Carolina
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Columbia, South Carolina, États-Unis, 29208
- 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Ages 18-65yr
- Diagnosis of PTSD
- CAPS >30
- Reported combat exposure per the Deployment Risk and Resilience Inventory (DRRI)
- Sedentary lifestyle (planned activity for purpose of health < 2 days/wk)
- Capability of giving informed consent
Exclusion Criteria:
- Abuse of alcohol or drugs
- Homelessness
- Significant cognitive impairment (e.g., MMSE score of ≤ 26) that would hinder ability to understand the protocol
- Signs or symptoms of cardiovascular, metabolic or pulmonary disease that would preclude participating in the exercise, including uncontrolled hypertension (> 159/99 mm Hg)
- Usage of beta blockers, which could influence the heart rate response to exercise
- Any physical or mental health condition that would contraindicate participation in the study (e.g., musculoskeletal, orthopedic, and/or neuromuscular disorders)
- High suicidality
- Below cutoff on either STAI (<30) or PCL-M (<40)
- Pregnancy or plans to become pregnant in the next 4 months
- Excessive levels of physical activity assessed via interview and pedometer recording
- Current treatment for PTSD (drug or counseling) for a duration of less than eight weeks
- Clinically judged to be unsuitable for participation by the research physician
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Exercise treatment
Aerobic and resistance training
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Participants will engage in 3 aerobic and resistance exercise sessions (~60-75 min total per session) weekly for 8 consecutive weeks. Aerobic exercise will be performed for 30 minutes on a treadmill 3 times weekly. Before beginning, 10 min of stretches will be performed. Each exercise bout will begin and end with a 5-min warm-up and 5-min cool-down on the treadmill, not included in the prescribed exercise duration. Eight resistance exercises will be performed immediately following the aerobic exercise: lat pulldown, triceps pushdown, seated chest press, upright row, bicep curls, leg press, shoulder press, and abdominal crunches. Participants will perform two sets of 10 repetitions of each. A rest interval of 60 seconds will be taken between exercises. Research staff will initially assist the participants in choosing the proper resistance to use, and weight will be increased once 15 repetitions can be performed while maintaining proper form. |
Expérimental: Stretching treatment
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Participants will engage in stretching sessions that will focus on whole-body flexibility.
Participants will perform 3 sessions per week (~60 min) of 3 sets of 14 stretches focused on the muscle groups targeted by the exercise training (i.e., deltoids, pectorals, lats, forearms and biceps, triceps, quadriceps, hamstrings, and groins).
Each stretch will be performed for 20 seconds and a rest interval of 60 seconds will be taken between each set.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder.
Délai: from pre- to post-treatment during 8-week intervention.
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Efficacy will be determined by a reduction in posttraumatic stress disorder symptoms as measured by the Clinician-Administered PTSD Scale-2 (CAPS-2).
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from pre- to post-treatment during 8-week intervention.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Feasibility as measured by adherence to the intervention.
Délai: during the 8-week intervention
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Feasibility will be determined by adherence to the intervention as measured by participation ≥ 2 times per week at the prescribed intensity for ≥ 80% of the exercise bouts.
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during the 8-week intervention
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Efficacy as measured by improvements in strength and fitness.
Délai: from pre- to post-treatment during 8-week intervention.
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Efficacy will be determined by improvements in strength and fitness.
Fitness will be measured as graded maximal treadmill VO2max test performance.
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from pre- to post-treatment during 8-week intervention.
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Shawn D. Youngstedt, Ph.D., University of South Carolina
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
- INTRuST-Exercise
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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