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CTRI Number  CTRI/2023/02/049485 [Registered on: 06/02/2023] Trial Registered Prospectively
Last Modified On: 03/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   effect of 6 weeks of Pilltes exercise on womens (between age 40 to 50 who have irregular menstrual cycle from past 6 months) core strength (abdominal strength), pelvic floor muscle strength and tiredness. 
Scientific Title of Study   " To check the effect of mat Pilates training on fatigue, pelvic floor muscle and core muscle strength in perimenopausal women: An experimental study." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mital odedra PT 
Designation  Post Graduate Student 
Affiliation  RK University, gujarat, india. 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India 
Phone  0635921304  
Fax    
Email  modedra985@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr komal doshi 
Designation  Post Graduate Student 
Affiliation  RK University, gujarat, india. 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India 
Phone  07405346112  
Fax    
Email  komal.doshi@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Mital odedra PT 
Designation  Post Graduate Student 
Affiliation  RK University, gujarat, india. 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India 
Phone  0635921304  
Fax    
Email  modedra985@rku.ac.in  
 
Source of Monetary or Material Support  
School of physiotherapy, RK University 
 
Primary Sponsor  
Name  Mital Odedra 
Address  School of Physiotherapy, RK University, Kasturbadham , Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India. 
Type of Sponsor  Other [by self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mital Odedra  RK University, school of physiotherapy musculoskeletal department  1st floor, musculoskeletal laboratory, department of physiotherapy RK University, Kasturbadham , Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT 		 06359213047

modedra985@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  perimenopausal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group a - mat Pilates exercises group. frequency- 4 days a week WARM UP- upper and lower body movements EXERCISE PHASE- 1 pelvic curl 2 single leg lifts 3 pre hundred prep 4 hundred prep 5 hundred 6 leg pull front 7. goal post COOL DOWN- long muscle stretching and relaxation. ( INTERVENTION timing per session- 45 minutes to 60 minutes)   after evaluation with perimenopausal fatigue questionnaire, perineometer and pressure biofeedback selection of 50 participants will be done, even number of patients will be given mat Pilates exercises with 8 repetitions and 3 sets training for 6 weeks for 4 sessions a week. all the above exercises will be done in group session with supervision.  
Intervention  group b - core muscle strengthening group. Frequency 4 days a week. WARM UP- upper and lower body movements EXERCISE PHASE- BASIC LUMBAR STABILIZATION WITH PROGRESSIVE LIMB LOADING- EMPHASIS ON ABDOMINALS with 6 levels. level 1 core activation, level 2 opposite lower extremity on bent leg fall out , level 3 opposite lower extremity on table, level 4 hold opposite extremity at 90 degree of hip flexion with upper extremity, level 5 hold opposite lower extremity at 90 degree of hip flexion, level 6 bilateral lower extremity movement BASIC LUMBAR STABILIZATION WITH PROGRESSIVE LIMB LOADING- EMPHASIS ON TRUNK EXTENSORS level 1 flex one upper extremity , level 2 extend one lower extremity by sliding it , level 3 extend one lower extremity and lift off exercise mat , level 4 flex one upper extremity and extend contralateral lower extremity, level 5 extend one lower extremity level 6 lift head, arms and lower extremity. INTERVENTION Timing per session- 45 minutes to 60 minutes  after evaluation with perimenopausal fatigue questionnaire, perineometer and pressure biofeedback selection of 50 participants will be done, ODD number of patients will be given core muscle strengthening exercises, kegels exercises and relaxation exercises 8 repetitions and 3 sets for 6 weeks for 4 sessions a week. all the above exercises will be done in group session with supervision. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Age: Between 40 to 50 Years
Inconsistent menstrual cycle from past a year 
 
ExclusionCriteria 
Details  1.Cancer patients
2.History of trunk & perineal trauma in past 6 months
3.Recent gynecological surgery
4.non-cooperative patients
5.Any other pathology of female reproductive system except incontinence
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.perimenopausal fatigue questionnaire.
2.perineometer device
3.pressure biofeedback device
 		 baseline and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

“TO CHECK THE EFFECT OF MAT PILATES TRAINING ON FATIGUE, PELVIC FLOOR MUSCLE AND CORE STRENGTH IN PERIMENOPAUSAL WOMAN: AN EXPERIMENTAL  STUDY”

KEY WORDS: Fatigue, Perimenopause, Pilates

BACKGROUND: fatigue is one of the most common sign of perimenopause with prevalence rate of 25%-45%. Estrogen is believed to contribute to it, although the underlying pathophysiology is still poorly understood. In perimenopausal women physiological process of aging is seen markedly, that is decrease in motor skills, reduced strength, flexibility, and speed, hindering daily activities and maintenance of a healthy lifestyle, although individual variation is considerable. Practicing regular physical exercises minimizes changes resulting from senescence and menopause as reflected by improved body composition, decreased joint pain and vascular resistance, increased bone mineral density, aerobic capacity, muscle strength and flexibility. In this study pilates will be given as an intervention for the Symptomatic treatment of fatigue in perimenopausal women. 

 

METHOD:

Baseline assessment of fatigue, pelvic floor muscle strength and core muscle strength will be taken by perimenopausal fatigue scale, perineometer and by pressure biofeedback. Participants will be divided equally into two groups- experimental group and control group. After which an intervention of mat pilates for 6 weeks (4 days/week) will be given to experimental group and energy conservation technique, plank and kegels. Post assessment will be taken after 6 weeks.

 

AIM: Check the effectiveness of pilates training on fatigue in perimenopausal woman: an experimental study.

 
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