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CTRI Number  CTRI/2024/12/077986 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The Link Between Eating Breakfast and physical Fitness in Women After Menopause 
Scientific Title of Study   Association Between Breakfast Consumption Frequency And Physical Fitness Variables In 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  Harshita Chaudhari 
Designation  Intern 
Affiliation  Dr.DY Patil College Of Physiotherapy  
Address  Dr.DY Patil College Of Physiotherapy Out Patient Department,Pimpri,Pune.
Dr.DY Patil College Of Physiotherapy Out Patient Department,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India 
Phone  9767204587  
Fax    
Email  hrchaudhari04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ROOPA DESAI 
Designation  Professor 
Affiliation  Dr D Y Patil College of Physiotherapy Pimpri Pune 
Address  DR DY PATIL COLLEGE OF PHYSIOTHERAPY, Out Patient Department,PIMPRI,PUNE

Pune
MAHARASHTRA
411018
India 
Phone  9890992383  
Fax    
Email  roopa.desai@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  DR ROOPA DESAI 
Designation  Professor 
Affiliation  Dr D Y Patil College of Physiotherapy Pimpri Pune 
Address  DR DY PATIL COLLEGE OF PHYSIOTHERAPY, Out Patient Department,PIMPRI,PUNE

Pune
MAHARASHTRA
411018
India 
Phone  9890992383  
Fax    
Email  roopa.desai@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr D Y Patil College Of Physiotherapy Sant Tukaram Nagar Pune 411018 
 
Primary Sponsor  
Name  Harshita Chaudhari 
Address  Dr.DY Patil College of Physiotherapy,411018. 
Type of Sponsor  Other [] 
 
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 Roopa Desai  Dr D Y Patil College Of Physiotherapy Out Patient Department  DR DY PATIL COLLEGE OF PHYSIOTHERAPY,OUT PATIENT DEPARTMENT,ROOM NO.10.
Pune
MAHARASHTRA 
9890992383

roopa.desai@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Sub-Ethics Committee, Dr D Y Patil College Of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N911||Secondary amenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Women of age 45 to 65 years.
Women should have complete cessation of menstrual cycle for atleast 12 consecutive months.
Body mass index less than 30 Kg/ m2 (WHO Classification).


 
 
ExclusionCriteria 
Details  Recent fractures at upper or lower extremities.
Soft tissue injuries of upper and lower extremities within 6 months.
Arthritis in lower extremity and upper extremity joints.
Neurological conditions : Parkinson’s disease, Stroke.
History of diabetes mellitus.
Cardiac conditions.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modified Kuppuswamy Scale  5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
30 sec sit to stand test  8 weeks 
 
Target Sample Size   Total Sample Size="103"
Sample Size from India="103" 
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)   22/12/2024 
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="0"
Months="4"
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 - NO
Brief Summary  

A higher health status is thought to be linked to breakfast intake. It has been demonstrated that skipping breakfast on a regular basis is linked to a reduced quality of life, which includes a drop in physical fitness, a decrease in psychological well-being, and a decline in general health(1). In fact, researchers have recently started to pay attention to the link between eating breakfast and physical function (3,5). Breakfast is the first meal of the day that breaks the fast after the longest period of sleep and is consumed within 2 to 3 hours of waking Some researchers defines breakfast as an eating occasion that occurred between 5 AM and 10 AM on weekdays, and 5 AM and 11 AM on weekends(2). Eating breakfast on a daily basis increases intake of nutrients like calcium, iron, folate, and dietary fiber. Irregular breakfast consumption may contribute to grip strength decrease owing to nutrient imbalance; indeed, nutrition deficiency is a well-known predictor of low muscle function and muscle strength loss(3).

Loss of muscle strength has been associated to falls, loss of independence, functional impairment, and disability. Maintaining one’s independence and standard of living requires muscle strength. Therefore, it’s critical to comprehend the variables affecting muscle strength in order to encourage healthy growth and prevent chronic illnesses(4).

 Menopause is linked to a naturally occurring decline in estrogen, which raises visceral fat content and reduces strength, muscular mass, and bone density.

Women may lose muscle strength and power earlier than men because of the menopausal transition around the age of 50. There is substantial evidence to suggest that the decline in muscle mass could be related to the fall in estrogen that occurs all throughout the menopausal years. A number of significant factors have a role in the decrease of muscle mass in postmenopausal women (4). Sarcopenia, the progressive loss of muscle tissue, has been suggested as one of the major causes of deterioration of muscle performance with increasing age. It appears that the main causes of sarcopenia in postmenopausal women are oxidative stress, protein consumption, and physical inactivity. Similar to the reduction of muscular mass, menopause appears to coincide with the loss of muscle strength. It’s well knowledge that sarcopenia contributes to a reduction in muscle strength that occurs with age. Reduced muscle strength can be detrimental to impairments in physical functions, including walking speed, ascending stairs, getting out of a chair, and recovering from a loss of balance. Some authors suggested that the loss of muscle strength coincides with the estrogen deficit because of menopause, It is proposed that estrogen has an anabolic effect on muscle by the stimulation of IGF-1 receptors. Through the actions of both IGF-1 and estrogen, estrogen receptors may have an impact on muscle strength.
However, muscle mass and strength are likely to be impacted by the decline in both IGF-1 and estrogen that occurs with menopause.
muscle strength is known to play an important role in functional performance and quality of life, the decline in power output is the most important factor of muscle strength and function in postmenopausal women, contributing to the risk of falls and fractures. For these reasons, we focused on postmenopausal females in our observational study with the purpose of examining the relationship between breakfast eating frequency and physical fitness measures. It is believed that breakfast consumption might be related to physical fitness because lower energy intake causes decreased muscle strength (6). It is widely recognized that a person’s muscle strength is a reliable indicator of their overall health. In the meanwhile, the most straightforward way to evaluate muscle function in clinical practice is by grip strength evaluation, which is a technique that is advised for measuring muscular strength(5). There was additional evidence linking low grip strength to the existence of chronic illnesses, falls, and disabilities. Consuming breakfast on a regular basis has been related to increased physical activity (PA), which can strengthen grips and stave off strength loss. Thus, results suggest that eating habits may have an impact on grip strength (5). Hence, our study aimed to systemically review that whether eating breakfast is substantially associated with stronger skeletal muscles in the upper and lower limbs as measured by grip strength and a 30-second sit-to-stand test.

 
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