- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07819448
Aerobic Exercise as an Adjunct Therapy for Depression
Role of Aerobic Exercise as an Adjunct Therapy in the Treatment of Depression in South Punjab, Pakistan
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study will compare two groups A and B for 06 weeks to study the reduction in severity of depression.
- Comparison group (Group-A): In this group participants will receive standard antidepressant treatment such as Sertraline (SSRIs) and psychotherapy (CBT) only. After 06 weeks, patients will again be assessed for their level of depression using the BDI scale.
- Experimental group (Group-B): In this group participants will undergo structured exercise program in addition to conventional pharmacotherapy and psychotherapy. They will be introduced to aerobic exercises which includes cycling and brisk walking and will undergo three supervised sessions for 35 minutes each, per week for total 06 weeks under supervision of trainee psychiatry.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Manahil Gill, MBBS
- Telefonnummer: +92 304 6527981
- E-post: manahilgill143@gmail.com
Studer Kontakt Backup
- Navn: Muhammad Ahsan Mustafa, MBBS
- Telefonnummer: + 92 333 3396180
Studiesteder
-
-
Punjab Province
-
Chak Four Hundred Fifty-four, Punjab Province, Pakistan, 63100
- Rekruttering
- CMH Bahawalpur
-
Ta kontakt med:
- Manahil Gill, MBBS
- Telefonnummer: +92 304 6527981
- E-post: manahilgill143@gmail.com
-
Hovedetterforsker:
- Manahil Gill, MBBS, Registrar Psychiatry
-
Hovedetterforsker:
- Beenish Hassan Khan, MBBS, FCPS Psychiatry
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Hovedetterforsker:
- Mansoor Mustafa, MBBS, FCPS Psychiatry
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
i. All new patients diagnosed with moderate and severe depression using BDI scale according to ICD-11 criteria between the ages of 18-55 years.
ii. Both genders will be included.
Exclusion Criteria:
i. Patients with severe physical disabilities such as Spinal cord injuries, severe osteoporosis or medical conditions that prevent exercise such as ischemic changes in ECG pre-exercise.
ii. Pregnant females. iii. Individuals already engaging in physical activities like athletes.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Comparison
Participants will receive conventional treatment only for 06 weeks
|
|
|
Eksperimentell: Aerobic Exercise
Participants will receive structured aerobic exercise cycling or brisk walking in addition to conventional treatment for 06 weeks
|
Participants will receive structured, supervised aerobic exercise ( cycling, brisk walking), in addition to conventional treatment consisting of 03 sessions per week, 35 minutes each for 06 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Beck Depression Inventory (BDI) score
Tidsramme: Baseline to 06 weeks
|
The primary outcome will be the mean change in Beck Depression Inventory (BDI) score from baseline to the end of 06 weeks intervention period.
It is a 21- item self-report scale with total scores ranging from 0 to 63. Lower scores indicate fewer depressive symptoms and therefore a better outcome.
The mean change in BDI score will be compared between the aerobic exercise (plus conventional treatment ) group and the non exercise group.
(conventional treatment only).
|
Baseline to 06 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Elgendy H, Shalaby R, Agyapong B, Lesage D, Paulsen L, Delday A, Duiker S, Surood S, Wei Y, Nkire N, Agyapong VIO. Effectiveness of Group Physical Exercise in Treating Major Depressive Disorder: An Analysis of Secondary Data from an Aborted Randomized Trial. Behav Sci (Basel). 2024 Mar 8;14(3):219. doi: 10.3390/bs14030219.
- Imboden C, Gerber M, Beck J, Holsboer-Trachsler E, Puhse U, Hatzinger M. Aerobic exercise or stretching as add-on to inpatient treatment of depression: Similar antidepressant effects on depressive symptoms and larger effects on working memory for aerobic exercise alone. J Affect Disord. 2020 Nov 1;276:866-876. doi: 10.1016/j.jad.2020.07.052. Epub 2020 Jul 18.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1516/EC/03/2025
Plan for individuelle deltakerdata (IPD)
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