| CTRI Number |
CTRI/2024/12/078371 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Strength and aerobic exercises for sleep disorders and functional capacity among postmenopausal women |
|
Scientific Title of Study
|
Effect of Aerobic vs Resistance Exercises on Sleep Quality, Insomnia and Functional Capacity among Postmenopausal 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 |
Ishika Sahu |
| Designation |
MPT Student |
| Affiliation |
Chhatrapti Shahu Ji Maharaj University, Kanpur, Uttar Pradesh |
| Address |
Physiotherapy OPD, Room no SHS-106, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur Uttar Pradesh.
Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
6000403985 |
| Fax |
|
| Email |
sahu332167@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ishika Sahu |
| Designation |
MPT Student |
| Affiliation |
Chhatrapti Shahu Ji Maharaj University, Kanpur, Uttar Pradesh |
| Address |
Physiotherapy OPD, Room no SHS-106, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur Uttar Pradesh.
Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
6000403985 |
| Fax |
|
| Email |
sahu332167@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hina Vaish |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University |
| Address |
Room no SHS-126, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur Uttar Pradesh
Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
9450124758 |
| Fax |
|
| Email |
hinavaish@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India. Pincode- 208024 |
|
|
Primary Sponsor
|
| Name |
Ishika Sahu |
| Address |
Physiotherapy OPD, Room no SHS-106, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur Uttar Pradesh. |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Hina Vaish |
Physiotherapy OPD, School of Health Sciences |
Physiotherapy OPD, Room no SHS-106, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur Uttar Pradesh. Kanpur Nagar UTTAR PRADESH |
9450124758
hinavaish@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee,Chhatrapati Shahu Ji Maharaj University,Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postmenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercises |
Participants will receive aerobic training in the form of treadmill walking at moderate intensity of 65-75% of HR max |
| Intervention |
Resistance exercises |
Participants will receive resistance training with the help of theraband.8 repetitions for 3 set per exercise with 2 minutes rest periods for the subjects in 3 days of a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women; with absence of menstruation from last one year and their menopausal status will be confirmed by asking series of questions,poor sleep quality with a total score of 5 or greater on the Pittsburgh Sleep Quality Index and a score greater than 8 in the Insomnia Severity Index score,Age 40 to 60 years,Body Mass Index (BMI)18.5-24.9 kg/m2,asymptomatic with stable vitals.
|
|
| ExclusionCriteria |
| Details |
Participants with systolic BP less than 100 mm Hg and greater than 139 mm Hg; diastolic BP less than 60 mm Hg and greater than 89 mm Hg, Resting Heart Rate less than 60 bpm and greater than 99 bpm, smokers, participants who had undergone hormone replacement therapy,any documented use of medications or any health problem that might affect the outcomes of the study or interfere with the normal ability to walk (such as use of walking aids, impaired cognition or sensation, neurologic, metabolic, cardiac, or orthopedic disease, sleep disorders) ,Any history of previous hospitalization or trauma in the past 6 months, participants who are involved in any kind of regular exercise, sports/athletic events, Pregnancy in the last 2 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sleep quality (Pittsburgh Sleep Quality Index)
Insomnia (Insomnia Severity Index)
Functional capacity (Six-minute walk test) |
Baseline
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ratings of Perceived Exertion (RPE) |
Baseline
4th week |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
29/12/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Background:
The
global population of postmenopausal women is increasing over 26% of women aged
50 accounted globally in the year 2021, which was at 22% a decade earlier. A
woman undergoing the process of menopausal transition goes through lots of
physiological changes with her age and faces new symptoms. Upon reaching this
phase, more than 50% of women reports problem with their sleep. Sleep disorders
have many negative effects on health, including an increase in risk of chronic
diseases, decreased daily functioning, decreased mood, reduced use of
healthcare and female sexual dysfunction. One of the major symptoms that a
woman faces during her menopause is insomnia; poor sleep initiation,
maintenance, duration of quality that impairs daily functioning is often
described as insomnia; loss of functional capacity among postmenopausal women
is also a common feature.
Need of the Study:
There
exists evidence that poor sleep quality and insomnia is associated with
deteriorated functional capacity. To the best of our knowledge, there is
scarcity of researches comparing the effect of resistance exercises vs aerobic
exercises on sleep quality, insomnia and functional capacity among
postmenopausal women.
Aim:
The aim
of this study is to study the effect of aerobic vs resistance exercise on sleep
quality, insomnia and functional capacity among postmenopausal women.
Methodology: In this
study, postmenopausal women will be screened first and those fulfilling the
inclusion criteria of our study will be selected. The written consent will be
signed from the patient to ensure that they are willingly participating in the
study. The consent shall be taken before commencement of the study. The
participants will be explained about the study procedures. The women will be
randomly divided into two groups (A and B) of equal participants i.e. 12 women
in each group using block randomization method. Then, the baseline assessments
of sleep quality, insomnia and functional capacity will be done; and all the evaluative
measures will be done at the start and after the end of the study. In this
study, postmenopausal women will be screened first and those fulfilling the
inclusion criteria of our study will be selected. The written consent will be
signed from the patient to ensure that they are willingly participating in the
study. The consent shall be taken before commencement of the study. The
participants will be explained about the study procedures. The women will be
randomly divided into two groups (A and B) of equal participants i.e. 12 women
in each group using block randomization method. Then, the baseline assessments
of sleep quality, insomnia and functional capacity will be done; and all the evaluative
measures will be done at the start and after the end of the study. Protocol for
aerobic exercise: The exercise
session will be of 50 minutes that consists of 10 minutes of warm up, 30
minutes on the treadmill and 10 minutes of cool down for three days per week
for 4 weeks. Participants will
receive moderate aerobic training in the form of 30 min of treadmill walking.
The maximum heart rate (MHR) will be estimated by subtracting 220 by the age of
the participant (MHR = 220- age); and the corresponding value to a target heart
rate of 65-75% of HR max will be calculated and achieved by the participant. Warm up and cool down will be performed before and after the session respectively. Protocol for
resistance exercise:
6 exercises will be taught to the subjects using
the theraband and they are the diagonal flexion, concentration curl, dynamic
hug, seated row, side bend and extension of hips and legs. 8 repetitions for 3
set per exercise with 2 minutes rest periods for the subjects in 3 days of a
week for 4 weeks will be the time period for the resistance exercises. Warm up and cool down will be performed before and after the session respectively. |