| CTRI Number |
CTRI/2024/04/065050 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of hip muscle strengthening exercises on pelvic floor muscle strength in middle-aged women |
|
Scientific Title of Study
|
Effect of hip muscle strengthening exercises over pelvic floor muscle strength in middle aged women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva H T |
| Designation |
MPT womens health |
| Affiliation |
Sri Ramachandra Institute of higher education and research |
| Address |
Faculty of Physiotherapy,
Sri Ramachandra Institute of Higher Education and Research,
No 1 Sri Ramachandra Nagar, Porur, Chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
8939358127 |
| Fax |
|
| Email |
apoorvaht311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Ponmathi P |
| Designation |
MPT Womens health |
| Affiliation |
Sri Ramachandra Institute of higher education and research |
| Address |
Faculty of Physiotherapy,
Sri Ramachandra Institute of Higher Education and Research,
No 1 Sri Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathiparamanandam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Ponmathi P |
| Designation |
MPT Womens health |
| Affiliation |
Sri Ramachandra Institute of higher education and research |
| Address |
Faculty of Physiotherapy,
Sri Ramachandra Institute of Higher Education and Research,
No 1 Sri Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathiparamanandam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apoorva H T |
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Apoorva H T |
| Address |
No 1 sri ramachandra nagar, porur, chennai 116 |
| 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 Apoorva H T |
Sri Ramachandra Hospital |
Sri Ramachandra Hospital Gynecology and Obstetrics department 1st floor
No 1 sri ramachandra nagar porur chennai 116
Chennai
TAMIL NADU |
8939358127
apoorvaht311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women without incontinence |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hip Strengthening Exercises along with pelvic floor exercises and abdominal exercises |
Hip : Clamshells, Isometric hip external rotation, Monster Walks (with resistance bands)
Pelvic Floor :
First 4 weeks Supine: 10 contractions of 5 secs, 15 contractions of 3 secs, 20 contraction of 1 sec., 5
contractions while
coughing.
Next 4 weeks: Supine Position: 10 contractions of 5 secs, 15 contractions of 3 secs, Sitting : 20
contractions of 2
seconds, 20 contraction of 1 sec., 5 contractions while coughing.
Following 4 weeks:
Sitting: 10 contractions of 5 secs, 15 contractions of 3 secs, Standing: 20 contractions of 2
seconds, 20 contraction of 1 sec., 5 contractions while coughing.
Last 4 Weeks: Standing Position: 10 contractions of 5 secs, 15 contractions of 3 secs, 20 contractions of 2 seconds, 20
contraction of 1 sec., 5 contractions while
coughing.
Abdominals :
Activation exercises of the
transversus abdominis muscle performed in different positions
|
| Comparator Agent |
Only Pelvic floor and abdominal exercises |
Pelvic Floor : First 4 weeks Supine: 10 contractions of 5 secs, 15 contractions of 3 secs, 20 contraction of 1 sec., 5 contractions while coughing. Next 4 weeks: Supine Position: 10 contractions of 5 secs, 15 contractions of 3 secs, Sitting : 20 contractions of 2 seconds, 20 contraction of 1 sec., 5 contractions while coughing. Following 4 weeks: Sitting: 10 contractions of 5 secs, 15 contractions of 3 secs, Standing: 20 contractions of 2 seconds, 20 contraction of 1 sec., 5 contractions while coughing. Last 4 Weeks: Standing Position: 10 contractions of 5 secs, 15 contractions of 3 secs, 20 contractions of 2 seconds, 20 contraction of 1 sec., 5 contractions while coughing. Abdominals : Activation exercises of the transversus abdominis muscle performed in different positions |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous and Multiparous, no complaints regarding pelvic floor, normal pelvic floor strength |
|
| ExclusionCriteria |
| Details |
Women who have existing pelvic floor conditions
Nulliparous
Traumatic injury
Previous surgeries
Patients with a history of carcinoma ovary, cervix and endometrium.
• Osteoarthritis hip
• Women with mental illness and chronic disease including severe cardiovascular problems, neurological issues, severe musculoskeletal problems, severe hypertension and diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pelvic floor strength will be calculated using the modified Oxford scale and Otriz Scale by performing a finger per vaginal examination.
|
The intervention will last for up to 16 weeks, the pre and post-tests will be performed at the beginning and end of the 16 weeks respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hip external rotator strength |
16weeks |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 1 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="0"
Months="4"
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
|
A study reported that of 250 eligible females: 24% of them were unable to correctly perform the pelvic muscle exercises initially. Of the participants who reported current practice of pelvic muscle exercises, 23% of them performed the exercise incorrectly. Identifying commonly performed exercises that can also effectively activate the pelvic muscles, even if the patient is not aware, would be an important contribution. Various studies have found that the surrounding musculature supports the effective functioning of the pelvic floor, particularly the obturator internus muscle that functions as a hip external rotator. Multiple studies show positive effects of abdominal musculature training on improving the strength of pelvic floor musculature thus improving its strength and reducing the symptom of conditions such as urinary incontinence
|