| CTRI Number |
CTRI/2025/11/098188 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of High-Intensity Interval Training on Symptoms of Premenstrual Dysphoric Disorder in Young Women |
|
Scientific Title of Study
|
EFFECT OF HIGH-INTENSITY INTERVAL TRAINING (HIIT) IN PREMENSTRUAL DYSPHORIC DISORDER (PMDD): AN EXPERIMENTAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeevani Konda |
| Designation |
PG student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 28, Sagar Floor, Advanced Physiotherapy Centre, Department of OBG physiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
07385832741 |
| Fax |
|
| Email |
kondasanjeevani1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeevani Konda |
| Designation |
PG student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 28, Sagar Floor, Advanced Physiotherapy Centre, Department of OBG physiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
07385832741 |
| Fax |
|
| Email |
kondasanjeevani1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Bulbuli |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 28, Sagar Floor, Advanced Physiotherapy Centre, Department of OBG physiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar kore Hospital and Medical Research Center, Belagavi, 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sanjeevani Konda |
| Address |
Advanced physiotherapy, Room No. 39, Sagar Floor, KLEs Dr. Prabhakar Kore Hospital and MRC, Belagavi, Karnataka, 590010 |
| 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 |
| Dr Sanjeevani Konda |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre |
Room no. 28, Sagar Floor, Advanced Physiotherapy Centre, Department of OBG physiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA |
07385832741
kondasanjeevani1@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: F328||Other depressive episodes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High-intensity interval training |
Treatment protocol: this is a 4-week interventional protocol. In Week 1 (Introduction), participants perform 4 sessions per week at 80% max HR for 30 minutes, using 30s work and 30s rest across 10 rounds with basic moves like squats, jumping jacks, push-ups, high knees, and planks, followed by stretching. Week 2 (Progressive Overload) increases to 4–5 sessions at 85% max HR, with 40s work and 20s rest for 12 rounds, incorporating jump squats, burpees, lunges, mountain climbers, and bicycle crunches, ending with breathing and stretching. In Week 3 (Increased Challenge), the plan advances to 5 sessions at 85–90% max HR, with 45s work and 15s rest for 14 rounds, introducing deadlifts, plyometric lunges, skater jumps, push-ups with shoulder taps, and Russian twists, with stretching to cool down. Finally, Week 4 (Peak Week) pushes to 5 sessions at 90% max HR, structured as 50s work and 10s rest for 15 rounds, featuring box jumps, kettlebell swings, lateral hops, wall sits, and side planks with reach, finishing with progressive relaxation. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Females diagnosed with Premenstrual Dysphoric Disorder (PMDD), based on clinical criteria DRSP |
|
| ExclusionCriteria |
| Details |
Females on hormonal medication
Individuals with other comorbid conditions like musculoskeletal injuries, obesity, and neurological conditions.
Any inflammatory conditions.
Red flags of HIIT include anemia or low BP, pelvic floor dysfunction, pre-diagnosed depression or other psychological issues, hypermobility, or ligament laxity.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Daily Record of Severity of Problems (DRSP) |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| C-Reactive Protein (CRP) Levels |
60 mins |
| Visual Analogue Scale (VAS) |
2 mins |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Effect of High-Intensity Interval Training (HIIT) in Premenstrual Dysphoric Disorder (PMDD): An Experimental Study Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome characterized by physical, emotional, and behavioral symptoms that significantly impair daily life. Current pharmacological treatments, such as SSRIs and hormonal therapies, though effective, often have side effects and limitations, creating the need for safe, non-pharmacological alternatives. This study aims to evaluate the effect of a 4-week High-Intensity Interval Training (HIIT) program on PMDD symptoms in women aged 18–25 years. The intervention involves progressively structured HIIT sessions focusing on cardiovascular and strength exercises, delivered five times per week for 30 minutes each session. Outcomes will be assessed using the Daily Record of Severity of Problems (DRSP) for symptom monitoring, C-Reactive Protein (CRP) levels as a biomarker of inflammation, and the Visual Analogue Scale (VAS) for subjective symptom intensity. A quasi-experimental design with 35 participants will be employed, and statistical analysis will include paired t-tests and non-parametric tests where applicable. This study intends to explore whether HIIT can reduce systemic inflammation and symptom severity in PMDD, thereby providing a cost-effective, drug-free, and holistic management strategy to improve the quality of life in affected women. |