| CTRI Number |
CTRI/2022/10/046689 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
14/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF STRUCTURED EXERCISE PROGRAM FOR MANAGEMENT OF COGNITIVE AND PHYSICAL SYMPTOMS IN PREMENSTRUAL DYSPHORIC DISORDER |
|
Scientific Title of Study
|
EFFECT OF STRUCTURED EXERCISE PROGRAM FOR MANAGEMENT OF COGNITIVE AND PHYSICAL SYMPTOMS IN PREMENSTRUAL DYSPHORIC DISORDER – A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asmu Bhattarai |
| Designation |
Physiotherapist |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, Room no-39 Sagar Floor KLE Dr Prabhakar Kore Hospital and MRC Belgaum, Karnatka 590010,India
Advanced Physiotherapy Centre, Room no-39 Sagar Floor KLE Dr Prabhakar Kore Hospital and MRC Belgaum, Karnatka 590010,India
Belgaum
KARNATAKA
590010
India |
| Phone |
8660888120 |
| Fax |
|
| Email |
asmu.bhattarai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arati Mahishale |
| Designation |
Physiotherapist |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced physiotherapy centre, room no 39 sagar floor KLE Dr Prabhakar Kore hospital and MRC Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9632822622 |
| Fax |
|
| Email |
mphysioarati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asmu Bhattarai |
| Designation |
Physiotherapist |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, Room no-39 Sagar Floor KLE Dr Prabhakar Kore Hospital and MRC Belgaum, Karnatka 590010,India
Advanced Physiotherapy Centre, Room no-39 Sagar Floor KLE Dr Prabhakar Kore Hospital and MRC Belgaum, Karnatka 590010,India
KARNATAKA
590010
India |
| Phone |
8660888120 |
| Fax |
|
| Email |
asmu.bhattarai@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and MRC Belgavi, Adcanced Physiotherapy Centre |
|
|
Primary Sponsor
|
| Name |
Asmu Bhattarai |
| Address |
advanced Physiotherapy Centre, Room no-39 Sagar Floor KLE Dr Prabhakar Kore Hospital and MRC Belgaum, Karnatka 590010,India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Asmu Bhattarai |
KLE Dr Prabhakar Kore Hospital and mr |
advanced Physiotherapy Centre, Room no-39 Sagar Floor KLE Dr Prabhakar Kore Hospital and MRC Belgaum, Karnatka 590010,India
Belgaum
KARNATAKA |
8660888120
asmu.bhattarai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F39||Unspecified mood [affective] disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercise |
Aerobic exercise in the form of running, jogging given 3 times in a week for 2 weeks during follicular phase of menstrual cycle. |
| Intervention |
Structured Exercise |
Structured exercise comprising of ten different exercise given 3 times per week for 2 weeks during follicular phase of menstrual cycle |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
-Nulliparous females within the age of 19-25 years of age
-Diagnosed PMDD according to Premenstrual symptom screening tool (anger, anxiety, tearful, depressed mood any one of these should be severe)
-Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
-Secondary Dysmenorrhoea
- On anti-anxiety medications
- Pregnancy
- History of joint, muscle, and bone diseases that reduce their abilities of exercise |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Prospective Record of Impact and Severity of Menstrual Symptom (PRISM)
2.Daily record of Severity of Problem (DRSP) |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
28/10/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to know the effect of structured exercise program for management of cognitive and physical symptoms in premenstrual dysphoric disorder. The patients willing to participate will be screened and those fulfilling the inclusion and exclusion criteria will be recruited to the study. Those having premenstrual dysphoric disorder will be asked to fill PRISMA and DRSP on 22nd day of their menstrual cycle. They will be randomly allocated to one of the group. The intervention group will be provided with structured exercise which they will be asked to do for 3 times a week for 2 weeks in their follicular phase of menstrual cycle and the control group will be provided with conventional aerobic for same parameters. Post intervention evaluation will be scored again and the statistical analysis will be done to determine the results of the study. |