Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
5. marts 2014 opdateret af: Ravi Singareddy, Milton S. Hershey Medical Center
Clinical and Neuroendocrine/Metabolic Benefits of Exercise in Treatment Resistant Depression (TRD): A Feasibility Study
The objective of this study is to determine the effects of adjunct exercise in treatment resistant depression.
The central hypothesis for the research is that adjunct exercise with usual care in Treatment Resistant Depression (TRD) will have significant effects in improving the psychiatric symptoms in comparison to usual care alone.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants with treatment resistant depression will be recruited to participate in a 12-week clinical trial on the effects of adjunct moderate-intensity exercise versus usual care.
Primary outcome measure will be reduction in baseline scores on Hamilton Depression Rating Scale (17 item).
Secondary outcome measure will include reduction in baseline scores of clinical global impression severity, pittsburgh sleep quality index global score, scores on beck depression inventory, and improvement in actigraphic sleep.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Hershey Medical Center
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Being sedentary (exercising less than 3 times/week for > 20 minutes at moderate/vigorous intensity for each bout)
- Ability to come for supervised exercises up to 5 days/week.
- On stable doses of medication or psychotherapy (within last 1 month) for underlying depression and willingness to continue on stable dose or therapy schedule during active phase of study participation, with the exception of during acute exacerbation of symptoms of psychiatric illness.
- Being able to read, understand, and provide written informed consent.
Exclusion Criteria:
- DSM-IV TR Axis I diagnosis of bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance or alcohol abuse/dependence disorder (except nicotine dependence) in the past 12 months. Patients with current primary anxiety disorder will also be excluded.
- Behavioral or personality disturbances, which may significantly interfere with study participation.
- Evidence of acute suicidal risk.
- Medical contraindication for physical exercise (significant orthopedic or cardiopulmonary disorder) that would prevent regular aerobic exercise. The American College of Sports Medicine criteria for risk stratification will be used and where indicated medical clearance for exercise will be obtained through the subject's primary care physician.
- Pregnancy.
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Moderate Intensity Aerobic Exercise
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Individuals in this group will receive moderate intensity exercise in addition to their usual care (Medications+/-Psychotherapy).
The moderate intensity exercise program will involve gradual progression in exercise intensity and duration.
During the first 4 weeks, participants will attend 3 supervised sessions/week and will be asked to complete at least 2 unsupervised aerobic exercise sessions/week.
From weeks 5-8 the number of supervised sessions will be 2/week with at least 3 unsupervised aerobic exercise sessions/week.
From weeks 9-12, the participants will have only 1 supervised session/week and will be asked to complete at least 4 unsupervised aerobic exercise sessions/week.
In total, the participants will be required to complete 150 minutes of moderate physical activity/week.
Andre navne:
The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
Andre navne:
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Andet: Wait List/Usual Care
The subjects in this group will continue to receive the usual treatment that they were on at the time of enrollment through the wait list period of 12 weeks.
Subsequently they will receive the 12 weeks of aerobic exercise program intervention
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The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline on Hamilton Rating Scale for Depression-17 item (HRSD17)score
Tidsramme: Baseline, 6 weeks, and 12 weeks
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Hamilton Rating Scale for Depression-17 item (HRSD17, a well standardized measure of depression will be the primary measures of efficacy.
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Baseline, 6 weeks, and 12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in baseline scores of clinical global impression severity
Tidsramme: Baseline, 6 weeks, and 12 weeks
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Baseline, 6 weeks, and 12 weeks
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Change from baseline on Beck Depression Inventory-II score
Tidsramme: Baseline, 6 weeks, 12 weeks
|
This is a widely used reliable and standardized measure of depression.
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Baseline, 6 weeks, 12 weeks
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Change from baseline on Pittsburgh Sleep Quality Index (PSQI) global sleep quality score
Tidsramme: baseline, 6 weeks, 12 weeks.
|
PSQI is a widely used, reliable and standardized measure of subjecitve sleep
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baseline, 6 weeks, 12 weeks.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ravi Singareddy, MD, Penn State Univ. College of Medicine
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. juni 2011
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først indsendt
23. juni 2011
Først indsendt, der opfyldte QC-kriterier
27. juni 2011
Først opslået (Skøn)
28. juni 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 34749EP
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 .