- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manahil Gill, MBBS
- Phone Number: +92 304 6527981
- Email: manahilgill143@gmail.com
Study Contact Backup
- Name: Muhammad Ahsan Mustafa, MBBS
- Phone Number: + 92 333 3396180
Study Locations
-
-
Punjab Province
-
Chak Four Hundred Fifty-four, Punjab Province, Pakistan, 63100
- Recruiting
- CMH Bahawalpur
-
Contact:
- Manahil Gill, MBBS
- Phone Number: +92 304 6527981
- Email: manahilgill143@gmail.com
-
Principal Investigator:
- Manahil Gill, MBBS, Registrar Psychiatry
-
Principal Investigator:
- Beenish Hassan Khan, MBBS, FCPS Psychiatry
-
Principal Investigator:
- Mansoor Mustafa, MBBS, FCPS Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Comparison
Participants will receive conventional treatment only for 06 weeks
|
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Beck Depression Inventory (BDI) score
Time Frame: Baseline to 06 weeks
|
The primary outcome will be the mean change in BDI score from baseline to the end of 06 weeks intervention period, a reduction in BDI score indicates improvement in depressive symptoms.
|
Baseline to 06 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1516/EC/03/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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