| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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. |