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CTRI Number  CTRI/2024/03/063728 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
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   Effect of morning and evening variation in resistance training on cardiopulmonary functions among postmenopausal females 
Scientific Title of Study   Effect of diurnal variation in resistance training on cardiopulmonary functions among postmenopausal females 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Minaxi Saini 
Designation  Assistant Professor  
Affiliation  Saket College of Physiotherapy, Chandimandir, Panchkula (Haryana) 
Address  Room No. 66, Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana.

Panchkula
HARYANA
134107
India 
Phone  9041095121  
Fax    
Email  xs4minaxi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priyanka Yadav 
Designation  PG Student 
Affiliation  Saket College of Physiotherapy, Chandimandir, Panchkula (Haryana) 
Address  Room No. 55, College rehabilitation center, Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana.

Panchkula
HARYANA
134107
India 
Phone  8860151274  
Fax    
Email  priyankaydv107@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka Yadav 
Designation  PG Student 
Affiliation  Saket College of Physiotherapy, Chandimandir, Panchkula (Haryana) 
Address  Room No. 55, College Rehabilitation Center, Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana.

Panchkula
HARYANA
134107
India 
Phone  8860151274  
Fax    
Email  priyankaydv107@gmail.com  
 
Source of Monetary or Material Support  
Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana. 
 
Primary Sponsor  
Name  Priyanka Yadav 
Address  Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana. 
Type of Sponsor  Other [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 
Dr Priyanka Yadav  Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana.  Room number -216, Department of Physiotherapy, Civil Hospital, Sector-6, Panchkula, Haryana.
Panchkula
HARYANA 		 8860151274

priyankaydv107@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Postmenopausal Females 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Resistance Training  Body weight resistance training including push-ups, squatting, sit-up, bridging, pull down, trunk extension in quadruped position, heel raises. Subjects will perform 3 sets of each exercise per session and 2 minutes of res between each set. In one set 6-8 repetitions will be performed.  
Comparator Agent  Resistance Training   Resistance training in morning and resistance training in evening. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Postmenopausal females.
2.Natural Menopausal since at least 1 year.
3.Age – 40 to 60 years.
 
 
ExclusionCriteria 
Details  1.Stage 2 HTN (SBP equal to or greater than 160 mmHg or DBP equal or greater than 100 mmHg).
2.Any respiratory, cardiovascular, musculoskeletal, neurological, psychological issues etc. which can affect the outcome measures and study interventions.
3.Person with visual and hearing impairments.
4.Person doing regular exercise evaluated through Rapid Assessment of Physical Activity score (RAPA) 1 greater than 3, RAPA 2 equal to 0.
5.Obesity (BMI equal to or greater than 30 Kg/m2)
6.Uncontrolled blood sugar (HbA1c greater than 7%).
7.Patient at high risk for diabetes as per IDRS risk score.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Blood pressure
2. Heart rate
3. Pulmonary functions 		 Baseline(pre-intervention)
immediately post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. Body mass index
2. Waist circumference 		 Pre and post 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   20/03/2024 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  data repository

  6. For how long will this data be available start date provided 30-04-2025 and end date provided 30-04-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this study, postmenopausal females will be included. self body weight resistance training will be given to the participants. One group will perform exercises in morning and one group will perform exercise in evening to see the diurnal variation. Participants will perform self body weight resistance exercises which includes, push-up, squatting, sit-up, bridging, pull down, trunk extension in quadruped position and heel raises. There will be a warm up period of 5-10 minutes which includes stretching exercise and walking before starting the resistance training and there will be a cool down period also which include walking. Pre and post measurements of the outcome measures will be performed. Collected data will be analyzed statistically using appropriate tests. Result. discussion and conclusion will be written accordingly. 
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