| CTRI Number |
CTRI/2024/07/070964 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
TO find out the effect of aerobic exercise and yoga on musculoskeletal fitness, fatigue, quality of life and
endocrine parameter in women with polycystic ovary syndrome |
|
Scientific Title of Study
|
To compare the effect of aerobic exercise and yoga on musculoskeletal fitness, fatigue, quality of life and endocrine parameter in women with polycystic ovary syndrome |
| Trial Acronym |
NiL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirti |
| Designation |
PG student |
| Affiliation |
Pandit bhagwat Dayal Sharma University of health and sciences Rohtak |
| Address |
E - Block College of physiotherapy, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896929909 |
| Fax |
|
| Email |
kirtivinay97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dimple Choudhry |
| Designation |
Assistant Professor |
| Affiliation |
Pandit bhagwat Dayal Sharma University of health and sciences Rohtak |
| Address |
E - Block College of physiotherapy, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416666445 |
| Fax |
|
| Email |
dimplephysio80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dimple Choudhry |
| Designation |
Assistant Professor |
| Affiliation |
Pandit bhagwat Dayal Sharma University of health and sciences Rohtak |
| Address |
E - Block College of physiotherapy, PGIMS Rohtak
HARYANA
124001
India |
| Phone |
9416666445 |
| Fax |
|
| Email |
dimplephysio80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B. D. Sharma university of health Sciences, PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
College of physiotherapy PGIMS Rohtak |
| Address |
Pandit B.D. Sharma PGIMS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 Dimple Choudhry |
Pt. B. D. Sharma, PGIMS, Rohtak |
Ch. Ranbir singh OPD, Department of gynecology, room no. 177,PGIMS, Rohtak Rohtak Haryana
Rohtak
Haryana
PGIMS, Rohtak
Rohtak
HARYANA |
9416666445
dimplephysio80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| biomedical research ethics committee, Pt. B.D. Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E349||Endocrine disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AEROBIC EXERCISE |
Total duration - 30 min.
Aerobic exercise group Time
• Group lecture - 8 min.
Lecture on conventional modern medical
concepts about a healthy lifestyle including diet, exercise
• Warm up- 6min.
Mild jump
Moderate jump
High jump
Jumping jack
Standing gluteal kick or butt kick
High knee jumps
Alternate bend leg touch
14
• Stretching exercise- 6 min.
Neck stretching and rotation
Biceps and triceps stretch
Pectoralis stretched
Shoulder rotation
Side bending
Hamstring/ quadriceps stretched
Latissimus dorsi stretch
• Strengthening exercise- 6min.
Shoulder flexor
Shoulder internal rotator
Knee flexor/knee extensor
Lunges
• Aerobics exercise- 6 min.
Dance marching
Jumping jack
Biceps/triceps move
Single and double step touch Front and back touch
Side and back bending touch
Side leg raise
Forward leg raise touch
• Cooldown- 6 min.
Breathing exercise
Sitting forward bend and touch
Relaxing hamstring and quadriceps muscles
Cobra stretched
Butterfly stretched |
| Comparator Agent |
YOGA |
Total duration - 30 min.
Yoga group Time
• Group lecture- 8 min
Lectures, in the form of cognitive restructuring
based on the spiritual philosophy underlying yogic concepts.
• Surya Namaskar (Sun Salutation) 2 min
• Prone asanas
Cobra pose (Bhujangasana)- 1 min
Locust pose (Salabhasana)- 1 min
Bow pose (Dhanurasana)- 1 min
• Standing asanas
Triangle pose (Trikonasana)- 1 min
Twisted angle pose (Parsva-konasana)- 1 min
Spread-leg intense stretch (Prasarita padottanasana)- 1 min
• Supine asanas
Inverted pose (Viparita Karni)- 1 min
Shoulder stand (Sarvangasana)- 1 min
Plough pose (Halasana)- 1 min
• Sitting asanas
Sitting forward stretch (Paschimottanasana)- 1 min
Fixed-angle pose (Baddha-konasana)- 1 min
Garland pose (Malasana)- 1 min
• Guided relaxation (Savasana)- 10 min
• Breathing techniques (Pranayama)
Sectional breathing (Vibhagiya-Pranayama)- 1 min
Forceful exhalation (Kapala Bhati)- 1 min
Right-nostril breathing (Suryanuloma Viloma)- 1 min
Alternate-nostril breathing (Nadi suddhi)- 1 min
• OM meditation (OM Dhyana)- 2 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Patient (age 18-25 yr.) diagnosed for PCOS by gynecologist |
|
| ExclusionCriteria |
| Details |
History of smoking.
• Pregnancy.
• History of diabetes.
• History of congenital adrenal hyperplasia.
• History of thyroid diseases.
• History of musculoskeletal disorders. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
sit and reach test
Fatigue symptoms inventory (FSI)
SF – 36
A.M.H., LH., FSH, testosterone and prolactin
Waist-to-hip ratio |
At day-0, 42,72 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measurement of quality of life
Fatigue
Quality of life
Endocrine parameter
Waist-to-hip ratio |
At day-0, 42,72 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of aerobic exercise and yoga on musculoskeletal fitness, fatigue, quality of life and endocrine parameter in women with polycystic ovary syndrome. 60 sample size. Inclusion and exclusion criteria mentioned above. Randomized controlled trial. |