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Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

24 de abril de 2013 actualizado por: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Exercise: A Novel Treatment for Combat PTSD

The primary objective of this pilot intervention study is to examine the efficacy of exercise for reducing the symptoms of posttraumatic stress disorder (PTSD) and other psychiatric and somatic symptoms. The sample will be composed of veterans aged 18-65 with combat-related PTSD (N = 40). Participants will be randomly assigned to one of two groups. Participants in the exercise training group (n = 20) will receive three 60-75 minute sessions per week of combination aerobic and resistance training for eight weeks. In the control stretching group, participants (n = 20) will receive training in whole-body flexibility three times per week for eight weeks. Secondary objectives include 1) determining feasibility of the intervention (as measured by the percentage of prescribed days of exercise completed by each participant, and percentage of time exercising completed at the prescribed intensity and duration); 2) determining the influence of exercise training on aerobic fitness and strength in the sample; and 3) determining whether psychiatric/somatic symptom improvements are associated with improvements in fitness and strength. Finally, exploratory objectives will include examining whether exercise training can improve early signs of heart disease, and whether certain biomarkers (using MRI and fMRI data and inflammatory markers) are associated with treatment response.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

11

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29208
        • 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Ages 18-65yr
  2. Diagnosis of PTSD
  3. CAPS >30
  4. Reported combat exposure per the Deployment Risk and Resilience Inventory (DRRI)
  5. Sedentary lifestyle (planned activity for purpose of health < 2 days/wk)
  6. Capability of giving informed consent

Exclusion Criteria:

  1. Abuse of alcohol or drugs
  2. Homelessness
  3. Significant cognitive impairment (e.g., MMSE score of ≤ 26) that would hinder ability to understand the protocol
  4. Signs or symptoms of cardiovascular, metabolic or pulmonary disease that would preclude participating in the exercise, including uncontrolled hypertension (> 159/99 mm Hg)
  5. Usage of beta blockers, which could influence the heart rate response to exercise
  6. Any physical or mental health condition that would contraindicate participation in the study (e.g., musculoskeletal, orthopedic, and/or neuromuscular disorders)
  7. High suicidality
  8. Below cutoff on either STAI (<30) or PCL-M (<40)
  9. Pregnancy or plans to become pregnant in the next 4 months
  10. Excessive levels of physical activity assessed via interview and pedometer recording
  11. Current treatment for PTSD (drug or counseling) for a duration of less than eight weeks
  12. Clinically judged to be unsuitable for participation by the research physician

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Exercise treatment
Aerobic and resistance training
Conductual: exercise training

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.
Experimental: Stretching treatment
Conductual: Stretching training
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder.
Periodo de tiempo: from pre- to post-treatment during 8-week intervention.
Efficacy will be determined by a reduction in posttraumatic stress disorder symptoms as measured by the Clinician-Administered PTSD Scale-2 (CAPS-2).
from pre- to post-treatment during 8-week intervention.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility as measured by adherence to the intervention.
Periodo de tiempo: during the 8-week intervention
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.
during the 8-week intervention
Efficacy as measured by improvements in strength and fitness.
Periodo de tiempo: from pre- to post-treatment during 8-week intervention.
Efficacy will be determined by improvements in strength and fitness. Fitness will be measured as graded maximal treadmill VO2max test performance.
from pre- to post-treatment during 8-week intervention.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Colaboradores

U.S. Army Medical Research and Development Command

Investigadores

  • Investigador principal: Shawn D. Youngstedt, Ph.D., University of South Carolina

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2011

Finalización primaria (Actual)

1 de enero de 2013

Finalización del estudio (Actual)

1 de enero de 2013

Fechas de registro del estudio

Enviado por primera vez

20 de junio de 2012

Primero enviado que cumplió con los criterios de control de calidad

21 de junio de 2012

Publicado por primera vez (Estimar)

22 de junio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de abril de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

24 de abril de 2013

Última verificación

1 de abril de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • INTRuST-Exercise

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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