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CTRI Number  CTRI/2025/09/094151 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial to know the effect of a 20-minute brisk walk on anxiety symptoms in people with generalised anxiety disorder receiving medication 
Scientific Title of Study   Effect of a twenty-minute brisk walk on symptoms of generalized anxiety disorder, in addition to pharmacological treatment—A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Ramya Krishna 
Designation  Assistant professor 
Affiliation  Konaseema Institute of Medical Sciences and Reseach foundation 
Address  Room no.2, Department of psychiatry, old OP block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District.

East Godavari
ANDHRA PRADESH
533201
India 
Phone  08332885221  
Fax    
Email  ramyakrishna251@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K Ramya Krishna 
Designation  Assistant professor 
Affiliation  Konaseema Institute of Medical Sciences and Reseach foundation 
Address  Room no.2, Department of psychiatry, old OP block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District.

East Godavari
ANDHRA PRADESH
533201
India 
Phone  08332885221  
Fax    
Email  ramyakrishna251@gmail.com  
 
Details of Contact Person
Public Query
 
Name  K Ramya Krishna 
Designation  Assistant professor 
Affiliation  Konaseema Institute of Medical Sciences and Reseach foundation 
Address  Room no.2, Department of psychiatry, old OP block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District.

East Godavari
ANDHRA PRADESH
533201
India 
Phone  08332885221  
Fax    
Email  ramyakrishna251@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Konaseema Institute of Medical sciences and research foundation  
Address  Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Ramya Krishna  Konaseema Institute of Medical sciences and Research foundation  Room no.2, Department of psychiatry, old OP block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District.
East Godavari
ANDHRA PRADESH 
08332885221

ramyakrishna251@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  20-minute brisk walk  . Brisk walking for 20 minutes as a lifestyle modification will be advised over pharmacological treatment for 4 weeks in one group, while the other group will receive purely pharmacological treatment. 
Comparator Agent  Pharmacological treatment only  Brisk walking for 20 minutes as a lifestyle modification will be advised over pharmacological treatment in one group, while the other group will receive purely pharmacological treatment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Subjects who are newly diagnosed with Generalised anxiety disorder according to ICD-11.
2) 18-65 years of age
3) Patients who have given informed consent
4) Patients who have a sedentary lifestyle
 
 
ExclusionCriteria 
Details  1) People who were already doing physical activities
2) Any chronic physical illness
3) Any severe comorbid psychiatric illness
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be assessed by the Hamilton Anxiety Rating Scale.  at baseline, at 2 weeks and 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Anxiety disorders manifest across the lifespan and are characterized by excessive symptoms of fear and anxiety over a prolonged period, accompanied by behavioural changes and non-specific physiological arousal. It results in significant distress, functional impairment, disability, diminishment of educational and economic potential, and lowered quality of life. It is the world’s most common mental disorder, affecting 301 million people in 2019.  Women are more affected by anxiety disorders than men. Approximately 1 in 4 people with anxiety disorders receive treatment for this condition. The current prevalence of anxiety disorders (including PTSD and OCD) in India is 2.94%, according to the National Mental Health Survey 2016. Brisk walking is a moderate-intensity aerobic exercise, characterized by a faster pace than a stroll, typically around 3 miles per hour (or 100 steps per minute), and it raises your heart rate and breathing. Previous studies have demonstrated that moderate exercise, like brisk walking, improves depression, anxiety, and mental health in individuals. In the present study, we aimed to find the association between brisk walking and anxiety disorders among adults. 

Brisk walking for 20 minutes as a lifestyle modification will be advised over pharmacological treatment in one group, while the other group will receive purely pharmacological treatment. Compliance with brisk walking was assessed by giving a semi-structured self-reporting questionnaire to participants. The anxiety symptoms at baseline will be assessed using the Hamilton Anxiety Rating Scale (HAM-A) and repeated at the end of 2 weeks and 4 weeks. The assessor will be blinded to which group the participants belong.

 
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