| CTRI Number |
CTRI/2024/07/071291 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing Validating and Pilot testing of an Exercise Program for Post Menopausal Women |
|
Scientific Title of Study
|
Development, Validation and Pilot testing of a Multidimensional Rehabilitation Protocol for Post-menopausal 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 |
Poornima Maurya |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 1, Neurological OPD,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7042744360 |
| Fax |
|
| Email |
poornimamaurya97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 1, Neurological OPD,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No 1, Neurological OPD,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Poornima Maurya |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be University |
| 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 Akanksha Saxena |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room no 1, Neurological OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Ambala
HARYANA |
7906989678
akankshasaxena623@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post-menopause females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Warm up with aerobic training,
Resistance Training,
Cognition Exercises,
Cool down |
Warm up with aerobic training includes cycling and treadmill training
Resistance training includes Arm curls, cross
body reach, shoulder
front raises, banded
dumbbell T row,
Abdominal crunches,
dynamic quadriceps,
hamstring curls, calf
raises
Cognition exercises includes Trail making, Digit span, Stroop test, Games like elephant memory, shapes and
colour, jigjaw puzzles
Cool down includes strectbing exercises and relaxation exercises
Duration- 3 sessions per week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Age ≥ 45 years
Menopause ≥ 1 year
Females experiencing menopausal symptoms evaluated using Menopause Rating
Scale (MRS)
|
|
| ExclusionCriteria |
| Details |
Hormonal Replacement Therapy
Lipid lowering drugs
Thyroid
Diabetes
Any Hormonal disorder
Any neurological disorder
Any acute or chronic musculoskeletal inflammatory condition
Prior or current diagnosed depression, anxiety, sleep disorder
Any psychological illness
Recent gynecological surgery
Hypertension and taking anti-hypertensive drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Menopause Rating Scale
R-R Interval
Sympathetic Skin Response (SSR)
|
Baseline, 2nd week, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hot Flash Related Daily Interference Scale (HFRDIS)
Montreal Cognition Assessment (MoCA) |
Baseline, 2nd week, 4th week |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
ABSTRACT
Background: Menopause is a normal aging phenomenon in women which marks the end of the
reproductive phase. The overall prevalence of menopausal symptoms in all domains was reported as
87.7% which includes hot flushes, cognition, autonomic nervous disorders, sleep disturbances, mood
changes, anxiety, depressive symptoms, urogenital symptoms, fatigue, limb pain and paraesthesia,
and joint pain, etc. Estrogen is believed to be potent regulators of mind and body. Low levels of
estrogen during menopause is responsible for the impairments which leads to decrease in overall
quality of life of a post-menopausal women.
Purpose: The study aimed to develop, validate and pilot testing a multidimensional rehabilitation
protocol for post-menopausal women.
Methods: This study comprises two phases. First phase is concerned with the protocol
development and validation process. This phase includes Delphi method which will evaluate
the content validity of the protocol. Second phase consists of pilot testing of the protocol for
post-menopausal women.
Data Analysis: The collected data will be analyzed by using SPSS 16.0 version. Normality will be
assessed by Kolmogrov smirnov test. If the data is found to be normally distributed, it will be
presented as mean+SD and pearson correlation test will be used to analyse. If the data is found to be
not normally distributed, it will be presented as Median (Interquartile Range) and Spearman’s
correlation test will be used to analyse it.
Result: The protocol has been validated by a group of multidisciplinary experts. 7 experts responded
and evaluated each item of the protocol and suggested modifications. The content Validity of each
item was found to be between 0.86 and 1 whereas the S-CVI by average method was found to be 0.93
which was above the satisfactory level as suggested by Lynn i.e. above 0.83.
Keywords: menopause, hot flushes, cognition, quality of life |