| 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
|
|
|
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
|
|
|
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 family. The 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. |