ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625001453471

Ethics application status

Approved

Date submitted

30/04/2025

Date registered

19/12/2025

Date last updated

19/12/2025

Date data sharing statement initially provided

19/12/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of aerobic exercise on high-sensitivity c- reactive protein levels and mental health in obese adults

Scientific title

Effect of Aerobic Exercise on High-Sensitivity C-Reactive Protein Levels and Mental Health O in Obese Adults

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Obesity

Depression

Anxiety

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention exposure in this study involves a structured, moderate-intensity aerobic exercise program designed specifically for the experimental group (Group A). Under the kind supervision of a physical trainer and local health professional, 30 Participants will engage in aerobic sessions for a duration of 12 weeks, with a frequency of five days per week. Each session will last approximately 55 minutes and will follow a consistent format aimed at reducing inflammation and improving mental health indicators such as depression and anxiety. The session structure includes a 5-minute warm-up, followed by 5 minutes of stretching exercises to prepare the muscles and joints for physical activity. This is followed by 10 minutes of jogging, 10 minutes of brisk walking, and 10 minutes of running, all performed at a moderate intensity. The session concludes with a 10-minute cool-down period to help the body return to its resting state and reduce physical strain. A 1-minute rest interval is between each activity to allow for adequate recovery and to ensure safety. This protocol, adapted from Kamal and Ragy (2012), is designed to reduce adipose tissue, lower pro-inflammatory markers such as CRP, and contribute to improved mental health outcomes, particularly by alleviating symptoms of depression and anxiety in obese adults. The intervention will be carried out in a college playground to maintain consistency, encourage adherence, and ensure participant safety throughout the study period.

Intervention code [1]

Lifestyle

Intervention code [2]

Rehabilitation

Description of the comparator or control

The 30 participants in the control group will not receive any intervention.

Control group

Active

Outcomes

Primary outcome [1]

significant effect on high-sensitivity C-reactive protein (hs-CRP) levels

Timepoint [1]

Baseline (Pre-test): Prior to the start of the 12-week intervention Post-intervention (Post-test): After completion of the 12-week aerobic exercise program

Secondary outcome [1]

Change in mental health status (anxiety and depression levels)

Timepoint [1]

Baseline (Pre-test): Before starting the intervention Post-intervention (Post-test): At the end of 12 weeks

Secondary outcome [2]

a siginificant change in mental health

Timepoint [2]

Baseline (Pre-test): Before starting the intervention Post-intervention (Post-test): At the end of 12 weeks

Secondary outcome [3]

a significant change in Depression level

Timepoint [3]

Baseline (Pre-test): Before starting the intervention Post-intervention (Post-test): At the end of 12 weeks

Secondary outcome [4]

a significant channge in BMI,

Timepoint [4]

Before starting the intervention post-intervention (post test) at the end of 12 weeks

Eligibility

Key inclusion criteria

“Participants will be included if they had a body mass index (BMI) greater than or equal to 30 kg/m², classifying them as obese according to WHO criteria.”

Minimum age

18 Years

Maximum age

35 Years

Sex

Males

Healthy volunteers

Yes

Key exclusion criteria

Presence of chronic illnesses (e.g., cardiovascular, respiratory, hepatic, or musculoskeletal disorders).

Diagnosed with severe psychiatric conditions or currently under psychiatric treatment.

Use of medications that affect inflammation or mental health (e.g., anti-inflammatory drugs, antidepressants).

Current engagement in structured exercise programs or recent acute illness/infection (within the past 4 weeks).

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

To minimize selection bias and ensure the integrity of group assignments, allocation concealment will be maintained through a sealed opaque envelope method. After confirming participants meet the inclusion criteria and have provided informed consent, each eligible participant will be randomly assigned to either the intervention group (aerobic exercise) or the control group using computer-generated random numbers. Group assignments will be placed in sequentially numbered, opaque, sealed envelopes by a third party not involved in the recruitment or assessment process. These envelopes will only be opened by the study coordinator after the participant has been enrolled, ensuring that neither the participant nor the enrolling researcher is aware of the group assignment in advance. This procedure helps prevent selection and allocation bias and preserves the internal validity of the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Sequence generation will be conducted using a computer-generated randomization list with a 1:1 allocation ratio. An independent statistician will generate the sequence prior to recruitment to ensure random and unbiased group assignment into intervention and control groups. This process will help maintain the methodological rigor of the randomized controlled trial.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data was analyzed using IBM SPSS Statistics version 21.0, while graphical data visualization was performed using Python 3.10. Descriptive statistics were applied for the discreate variables and advanced statistical analyses were conducted using standard procedures appropriate for non-randomized controlled trials with repeated measurements. Normality of continuous outcomes was assessed using the Shapiro–Wilk test, which indicated that several baseline variables met the normality assumption, whereas some post-intervention and follow-up measures demonstrated deviations from normality. Given the robustness of parametric methods to mild violations of normality and the balanced sample size across groups, a two-way mixed Repeated Measures Analysis of Variance (RM-ANOVA) was employed to examine the main effects of time, group, and their interaction with variables.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

15/09/2025

Date of last participant enrolment

Anticipated

Actual

21/10/2025

Date of last data collection

Anticipated

Actual

4/12/2025

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Khyber Pakhtunkhwa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Afshan Jabeen , Assistant Professor, The University of Haripur Kp Pakistan

Address [1]

Country [1]

Pakistan

Primary sponsor type

Individual

Name

Afshan Jabeen ,The University of Haripur Kp Pakistan

Address

Country

Pakistan

Secondary sponsor category [1]

Individual

Name [1]

Abdur Rashid , assistant Professor, Higher Education Commission

Address [1]

Country [1]

Pakistan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics/Bioethics committee, University of Haripur

Ethics committee address [1]

Directorate of Advance Studies & Research Board, The University of Haripur, Hattar Road Haripur 22620, Khyber Pakhtunkhwa, Pakistan.

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

16/07/2025

Approval date [1]

08/08/2025

Ethics approval number [1]

UOH/DASR/2025/2836

Summary

Brief summary

This randomized controlled trial aims to evaluate the effects of a 12-week moderate-intensity aerobic exercise program on high-sensitivity C-reactive protein (hs-CRP) levels and mental health indicators, specifically anxiety and depression, in obese male adults. A total of 60 participants from Government Post Graduate College Peshawar will be randomly assigned to intervention and control groups. Pre- and post-intervention assessments will include hs-CRP blood tests and the Hospital Anxiety and Depression Scale (HADS). The study seeks to determine whether aerobic exercise can reduce systemic inflammation and improve mental health, offering a non-pharmacological approach to managing obesity-related health concerns. Findings may guide future interventions and public health policies targeting both physical and psychological aspects of obesity in similar populations.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Afshan Jabeen

Address

Department of Sports Science and Physical Education, Faculty of Social and Administrative Sciences, University of Haripur, Khyber Pakhtunkhwa, Pakistan

Country

Pakistan

Phone

+923165697984

Fax

[email protected]

Contact person for public queries

Name

Afshan Jabeen

Address

Department of Sports Science and Physical Education, Faculty of Social and Administrative Sciences, University of Haripur, Khyber Pakhtunkhwa, Pakistan

Country

Pakistan

Phone

+923165697984

Fax

[email protected]

Contact person for scientific queries

Name

Afshan Jabeen

Address

Department of Sports Science and Physical Education, Faculty of Social and Administrative Sciences, University of Haripur, Khyber Pakhtunkhwa, Pakistan

Country

Pakistan

Phone

+923165697984

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• Postal address: Dr Afshan Jabeen, assistant Professor,Department of Sports Science and Physical Education, Faculty of Social and Administrative Sciences, University of Haripur, Khyber Pakhtunkhwa, Pakistan

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					Ethical approval.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically