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CTRI Number  CTRI/2024/09/074112 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Exercise]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of physical activity to assess their level of drinking refusal self efficacy among patients with alcohol use disorders (AUD) attending de-addiction clinic in a tertiary health care centre, Puducherry- A Randomised Controlled Trial  
Scientific Title of Study   Effect of physical activity on drinking refusal self-efficacy among patients with alcohol use disorder (AUD) attending de-addiction clinic in a tertiary health care centre, Puducherry- A Randomised 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  Ajungla Walling 
Designation  M.Sc Psychiatric Nursing 
Affiliation  College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  M.Sc Psychiatric Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical education and Research, Puducherry-605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7005539925  
Fax    
Email  ajunglawalling777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajungla Walling 
Designation  M.Sc Psychiatric Nursing 
Affiliation  College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  M.Sc Psychiatric Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical education and Research, Puducherry-605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7005539925  
Fax    
Email  ajunglawalling777@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kavitha R R 
Designation  Tutor 
Affiliation  College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Department of Psychiatric Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9994248053  
Fax    
Email  kavirr80@gmail.com  
 
Source of Monetary or Material Support  
Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Kavitha R R  Jawaharlal Institute of Postgraduate Medical Education and Research  Deaddiction clinic, Psychiatric Department,Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006
Pondicherry
PONDICHERRY 
9994248053

kavirr80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for HUman Studies, Jawaharlal Institute of Postgraduate Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Physical activity   Patient in the intervention group will perform physical activity in the form of brisk walking for 3 weeks along with routine treatment. First week will have 3 sessions, second week will have 4 sessions and 5 sessions in the third week.Each session will be for 30 minutes. Before the start of brisk walking the participants will be asked to do stretching in order to avoid strain which will take 2 to 3 minutes. Both stretching exercise and brisk walking will be taught to patients through video recording, return demonstration will be encouraged from each participant. Text messages will be send every week to ensure participation. Leaflets containing stretching exercise and brisk walking will be distributed to reinforce knowledge. Exercise checklist will be distributed to record the days when exercise is done and alcohol Timeline Follow Back (TLFB)calendar will be distributed to record the amount of alcohol consumed daily during these 21 days od recruitment.Recording of the TLFB calendar will be done by the participant along with a reliable member of the family. Both checklist and TLFB calendar will be asked to bring during follow-up after 21 days. 
Comparator Agent  Routine treatment  The control group will receive routine treatment as usual for 21 days which includes- •Detoxification: A short course of benzodiazepine (diazepam or lorazepam) to help overcome the acute withdrawal state. this will continue for 21 days and more as per doctor advise •Psychotherapy: includes motivational interventions, and relapse prevention strategies for all patients,which will be given on the first day of attending deaddiction clinic •Stress reduction on the first day of attending deaddiction clinic  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  . Above 18 years of age
. Clinician diagnosed alcohol use disorder (AUD)
. Participants accompanied by a reliable family member 
 
ExclusionCriteria 
Details  •Participants with clinically diagnosed co-morbidities: Hypotension, cardiac abnormalities, musculoskeletal abnormalities or injuries, Schizophrenia, Bipolar disorder, or any acute psychiatric illness that will interfere with participation in the study.
•Patient enrolled for other physical therapies.
•Reported thoughts of self-harm.
•Pregnant women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of physical activity on drinking refusal self- efficacy among patients with alcohol use disorder attending de- addiction clinic in a tertiary health care centre in South India.  3 weeks (21 Days) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the severity of alcohol use and its socio-demographic and clinical determinants among patients with AUD attending de- addiction clinic in a tertiary health care centre in JIPMER.
2.To identify the association between drinking refusal self efficacy with its socio-demographic variables among patients with alcohol use disorder attending de-addiction clinic in a tertiary health care centre in JIPMER.
 
3 weeks (21 Days) 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/10/2024 
Date of Study Completion (India) 06/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This study is a randomized controlled trial to assess the effect of physical activity on drinking refusal self-efficacy among patients with alcohol use disorder (AUD) attending de-addiction clinic in a tertiary health care centre ,  Puducherry. Patients who meet the inclusion criteria will be enrolled from the de-addiction clinic by consecutive sampling method, the group will then be randomised based on the SNOSE method. Informed consent will be obtained and the data collection of each participant will be done. pretest of both the groups will be done using the using the Drinking Refusal Self-Efficacy Questionnaire-Revised (DRSEQ-R) and Severity of Alcohol Dependence Questionnaire (SADQ).Participants in the control group will get routine treatment as usual which includes: Detoxification, Psychotherapy and stress reduction.   Participants in the intervention group will be assigned to physical activity  along with routine treatment as usual.   Education on the effects and advantages of exercise on patients with AUD will be given.  A 15-minute recorded video containing stretching to be done before exercise and how to brisk walk will be shown along with a reliable family member of the participant.  Stretching exercises will include Back extension, neck forward, neck left and right, elbow pullover, shoulder over, shoulder across, shoulder back, bridge stretch, forearm & wrist, hamstring stretch, Calf stretch, quad & flexor stretch which will take 5-10 minutes. Physical activity will include brisk walking which will begin with 90 minutes in the first week gradually increasing to 150 minutes in the final week. The first week will include 3 sessions in a week. The second week will include 4 sessions and the third week will include 5 sessions. Each session will be for 30 minutes. Supervised return demonstration of stretching and brisk walking will be encouraged by each of the participants to assess their level of understanding. Leaflets containing stretching exercises and brisk walking will be distributed to reinforce knowledge.Text messages will be sent 3 days a week to ensure the participant performs the physical activity as advised. An exercise checklist will be distributed to the participant along with a reliable family member for recording the days when the exercise is done by the participant.. Adherence to the regimen will be assessed by self-reporting in the exercise checklist, which will be done by the participant along with a reliable family member along with the participant and asked to bring during follow-up.  Alcohol Timeline Follow Back calendar (TLFB) will be distributed to both groups to record the amount of alcohol consumed daily.  Recording of the TLFB calendar will be done by the participant along with a reliable member of the familyThe alcohol TLFB calendar will be asked to bring during follow-up i.e. after 21 days.  Post-test assessment to assess the drinking refusal self-efficacy for both the groups will be done using DRSEQ-R after 21 days at the de-addiction clinic, JIPMER.

  
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