NCT07819448

Brief Summary

The goal of this study is to compare the reduction in the severity of depression after a duration of 06 weeks between patients receiving conventional therapy (antidepressant; Sertraline) only and those receiving both conventional therapy and a structured aerobic exercise (cycling, brisk walking).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jun 2026Feb 2027

Study Start

First participant enrolled

June 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

September 9, 2026

Last Update Submit

September 14, 2026

Conditions

Depressive Disorder

Keywords

DepressionAerobic exerciseAntidepressant therapyPsychotherapyBeck Depression Inventory (BDI)

Outcome Measures

Primary Outcomes (1)

  • Change in Beck Depression Inventory (BDI) score

    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

Study Arms (2)

Comparison

NO INTERVENTION

Participants will receive conventional treatment only for 06 weeks

Aerobic Exercise

EXPERIMENTAL

Participants will receive structured aerobic exercise cycling or brisk walking in addition to conventional treatment for 06 weeks

Behavioral: Structured Aerobic exercise

Interventions

Structured Aerobic exerciseBEHAVIORAL

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.

Aerobic Exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Bahawalpur

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38540522BACKGROUND

  • 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.

    PMID: 32739704BACKGROUND

MeSH Terms

Conditions

Depressive DisorderDepression

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Manahil Gill, MBBS

CONTACT

+92 304 6527981manahilgill143@gmail.com

Muhammad Ahsan Mustafa, MBBS

CONTACT

+ 92 333 3396180

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Registrar Psychiatry, Combined Military Hospital Bahawalpur

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)