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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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