| CTRI Number |
CTRI/2025/08/093435 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
An Clinical trial to study effects of two intervention HIIT training and aerobic exercises in females with pcos |
|
Scientific Title of Study
|
A Randomized control trial to compare the effects of HIIT and aerobic exercises on anthropometric measurement and sleep quality in Females with PCOS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vipasha Kulkarni |
| Designation |
Master in Physiotherapy |
| Affiliation |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
v11 204 pratapgad ashokvan borivali east
Dr APJ Abdul Kalam College of Physiotherapy Pravara institute of medical science loni, ahmednagar
Ahmadnagar
MAHARASHTRA
400066
India |
| Phone |
09076348426 |
| Fax |
|
| Email |
vipasha204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Hande |
| Designation |
Head of Department , Community Physiotherapy |
| Affiliation |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
Dr APJ Abdul Kalam College Of Physiotherapy, Loni
Dr APJ Abdul Kalam College of Physiotherapy Pravara institute of medical science loni, ahmednagar
Ahmadnagar
MAHARASHTRA
413712
India |
| Phone |
8275034001 |
| Fax |
|
| Email |
deepali.hande@ |
|
Details of Contact Person
Public Query
|
| Name |
Vipasha Kulkarni |
| Designation |
Master in Physiotherapy |
| Affiliation |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
v11 204 pratapgad ashokvan borivali east
Dr APJ Abdul Kalam College of Physiotherapy Pravara institute of medical science loni, ahmednagar
Ahmadnagar
MAHARASHTRA
400066
India |
| Phone |
09076348426 |
| Fax |
|
| Email |
vipasha204@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr APJ Abdul Kalam College Of Physiotherapy |
| Address |
DrAbdul Kalam College of Physiotherapy, PIMS DU Loni |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aditi Khot |
DR APJ Abdul Kalam College of Physiotherapy , Loni |
| Dr Deepali Hande |
Dr APJ Abdul Kalam College of Physiotherapy , Loni |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vipasha Kulkarni |
Dr APJ Abdul Kalam College of Physiotherapy |
404 Community Physiotherapy Department Loni MH Pin 413736
Ahmadnagar
MAHARASHTRA |
09076348426
vipasha204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Dr APJ Abdul Kalam College Of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N94||Pain and other conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercises |
Aerobic Training Group
Participants will exercise four days a week for 40 minutes per session Intensity will be moderate during weeks 0 to 4 and vigorous from weeks 4 to 8 Each session includes a five minute warm up with walking active heel raises arm and leg exercises A six minute cardio segment follows including two minutes each of jumping jacks high knees and butt kicks Stair climbing is performed and the number of flights is recorded
A treadmill protocol is also included
Weeks 0 to 2 and 2 to 4 Speeds range from 23 to 28 mph with inclines from 5 to 11 percent
Weeks 4 to 6 Speeds increase to 38 mph with inclines up to 13 percent
Weeks 6 to 8 Speeds reach 42 mph and inclines go up to 16 percent
Each session concludes with a five minute cool down using Shavasana and the Laura Mitchell relaxation technique |
| Comparator Agent |
High Intensity Interval training |
High Intensity Interval Training involves alternating periods of intense effort and recovery The program will be conducted three days a week Each session begins with a fifteen minute standard warm up followed by a low intensity run This is followed by three repetitions of thirty seconds of sprint running each followed by thirty seconds of slow running The session concludes with five minutes of dynamic stretching |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women between age group 18 to 40 years
Women with PCOS
Women with any weight |
|
| ExclusionCriteria |
| Details |
Women who do physical activity regularly |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pittsburg Sleep Quality Index
BMI |
Baseline, 4 weeks , 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Height Weight |
Baseline 4 weeks 8 weeks |
|
|
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)
|
01/09/2025 |
| 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="11"
Days="30" |
|
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
|
Introduction
Polycystic ovarian syndrome is a chronic condition affecting 5 to 18 percent of reproductive females
Main features include hyperandrogenism oligoovulation anovulation and polycystic ovaries
Women with PCOS often experience poor sleep quality daytime tiredness insomnia and sleep apnea
Key causes are hyperinsulinemia and hyperandrogenism which disrupt sleep related genes
Weight gain high BMI and obesity are common in PCOS women
Lifestyle factors contribute to weight gain and abdominal obesity
Lifestyle changes and weight management are first line treatments
Sleep quality is assessed using Pittsburgh Sleep Quality Index higher score indicates poorer sleep
HIIT improves body measurements and aerobic function in PCOS
Aerobic exercises support weight loss metabolic balance and sleep quality
Supervised programs enhance fitness life quality and metabolic health in overweight women with PCOS Need for Study
Women with PCOS have more sleep issues including tiredness insomnia and risk of sleep apnea
Physical activity is essential to prevent these complications
Current treatments focus on hormones weight and insulin resistance
Sleep issues are emerging and require attention
Moderate to vigorous physical activity improves sleep and overall health
HIIT and aerobic exercises help with weight menstrual and psychological issues in PCOS
This study compares HIIT and aerobic exercise on sleep quality waist hip ratio weight and BMI Research Question
How effective is HIIT compared to aerobic exercise in improving sleep and body measurements in women with PCOS Aim
To assess the effectiveness of HIIT and aerobic exercise on sleep and body measures in PCOS Objectives
To evaluate HIIT and aerobic training effects on
sleep quality
weight
body mass index
waist hip ratio Procedure
Participants are informed and provide consent
Women aged 18 to 40 with PCOS are selected randomly
Two groups are formed one receives HIIT other aerobic training for 8 weeks HIIT Group
High intensity intervals with sprint and slow runs
3 sessions per week with warmup running sprints and stretching Aerobic Training Group
Four sessions per week for 40 minutes per day
Includes walking arm and leg exercises jumping jacks high knees butt kicks stair climbing treadmill and relaxation
Intensity and treadmill speed increase every two weeks from moderate to vigorous |