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Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

24. april 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise treatment
Aerobic and resistance training
Adfærdsmæssigt: 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.
Eksperimentel: Stretching treatment
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility as measured by adherence to the intervention.
Tidsramme: 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.
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Samarbejdspartnere

U.S. Army Medical Research and Development Command

Efterforskere

  • Ledende efterforsker: Shawn D. Youngstedt, Ph.D., University of South Carolina

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

20. juni 2012

Først indsendt, der opfyldte QC-kriterier

21. juni 2012

Først opslået (Skøn)

22. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INTRuST-Exercise

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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