Depressive DisorderNCT07819448
Aerobic Exercise as an Adjunct Therapy for Depression
A study testing Structured Aerobic exercise in people with Depressive Disorder, run by Manahil Gill at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Structured Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All new patients diagnosed with moderate and severe depression using BDI scale according to ICD-11 criteria between the ages of 18-55 years.
- Both genders will be included.
Who cannot join
- 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.
- Pregnant females. iii. Individuals already engaging in physical activities like athletes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Muhammad Ahsan Mustafa, MBBS contact
Pakistan1 site, 1 recruiting
- Recruiting
CMH Bahawalpur
Chak Four Hundred Fifty-four, Punjab Province, 63100
Manahil Gill, MBBS, +92 304 6527981, manahilgill143@gmail.com
Manahil Gill, MBBS, Registrar Psychiatry
About this study
Official title: Role of Aerobic Exercise as an Adjunct Therapy in the Treatment of Depression in South Punjab, Pakistan
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).
Read the 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.
- Conditions
- Depressive Disorder
- Being tested
- Structured Aerobic exercise
- Keywords
- Depression, Aerobic exercise, Antidepressant therapy, Psychotherapy, Beck Depression Inventory (BDI)
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Aerobic exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Structured Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 06 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jun 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manahil Gill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manahil Gill, Combined Military Hospital Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819448
- Sponsor's protocol ID
- 1516/EC/03/2025
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38540522Imboden 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.
PubMed 32739704
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Aerobic Exercise as an Adjunct Therapy in the Treatment of Depression in South Punjab, Pakistan
- ClinicalTrials.gov ID
- NCT07819448
- Acronym / sponsor ID
- 1516/EC/03/2025
- Conditions
- Depressive Disorder
- Keywords
- Depression, Aerobic exercise, Antidepressant therapy, Psychotherapy, Beck Depression Inventory (BDI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Manahil GillUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Comparison | No intervention | –Participants will receive conventional treatment only for 06 weeks |
| Aerobic Exercise | Experimental | Behavioral: Structured Aerobic exerciseParticipants will receive structured aerobic exercise cycling or brisk walking in addition to conventional treatment for 06 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All new patients diagnosed with moderate and severe depression using BDI scale according to ICD-11 criteria between the ages of 18-55 years.
- Both genders will be included.
Key exclusion criteria (2 listed)
- 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.
- Pregnant females. iii. Individuals already engaging in physical activities like athletes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Aerobic exerciseParticipants 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. | Behavioural | Aerobic Exercise |
Primary outcome
Change in Beck Depression Inventory (BDI) score
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 38540522Elgendy 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.
- Background: PubMed 32739704Imboden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Ahsan Mustafa, MBBS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Aerobic exercise in people with Depressive Disorder, run by Manahil Gill at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manahil Gill, MBBS (+92 304 6527981, manahilgill143@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Depression Inventory (BDI) score (time frame: Baseline to 06 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819448, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.