FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066223 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [structured exercise program]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of structured exercise program on quality of life  
Scientific Title of Study   Effect of structured exercise program on quality of life among menopausal women of selected areas of bhopal: a randomized controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya 
Designation  M.Sc. Nursing student, Nursing college  
Affiliation  AIIMS Bhopal 
Address  Transit PG Girls Hostel, saket nagar, AIIMS Bhopal pincode- 462020
Transit PG Girls Hostel, saket nagar, AIIMS Bhopal pincode- 462020
Bhopal
MADHYA PRADESH
462020
India 
Phone  9416131459  
Fax    
Email  PRIYA.mscnursing23@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Naseema Shafqat 
Designation  Assistant Professor, Nursing college, AIIMS Bhopal 
Affiliation  Nursing college, AIIMS Bhopal 
Address  Nursing college, AIIMS Bhopal
Nursing college, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  9907116675  
Fax    
Email  naseema.nursing@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Naseema Shafqat 
Designation  Assistant Professor , Nursing college, AIIMS Bhopal 
Affiliation  Nursing college, AIIMS Bhopal 
Address  Nursing college, AIIMS Bhopal
Nursing college, AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  9907116675  
Fax    
Email  naseema.nursing@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
Self funded by principals investigator 
 
Primary Sponsor  
Name  Priya Principal investigator 
Address  Transit PG girls hostel, AIIMS bhopal, Pincode-462020 
Type of Sponsor  Other [Self funded by researcher ] 
 
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 
Priya  Community area of bhopal  Bhopal
Bhopal
MADHYA PRADESH 		 9416131459

PRIYA.mscnursing23@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee- Student Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  menopausal women  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal daily living activities  Normal daily living activites  
Intervention  structured exercise program  40 minutes exercise, 4 days in week and for 6 weeks  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Confirmed menopausal status
Willingness to participate and provide informed consent.  
 
ExclusionCriteria 
Details  Having cardiovascular or musculoskeletal conditions.
Medical conditions contraindicating exercise.
Participation in any other structured program/exercise. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
quality of life   quality of life among menopausal women 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/08/2024 
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="1"
Days="15" 
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   Title of the study: Effect of structured exercise program on quality of life among menopausal women in selected areas of Bhopal: A randomised controlled trial. 
Background: Menopause is a significant life transition for women, marked by physiological and hormonal changes that often influence their overall quality of life. Menopausal symptoms not only affect the overall well-being and quality of life of women but may also contribute to the development of chronic conditions such as cardiovascular disease, osteoporosis, and metabolic disorders. Maintaining good health during and after menopause is crucial for preventing these long-term health risks. Physical activity, particularly aerobic exercise, has been recognized as a promising intervention to mitigate the negative effects of menopause. potential benefits of structured aerobic exercise on the quality of life during menopause have been suggested in various studies. This research aims to conduct a Randomized Controlled Trial (RCT) to assess the effect of a structured aerobic exercise program on the quality of life among menopausal women in selected areas of Bhopal. 
Need & justification: Menopause is a natural physiological transition, but it often brings about various physical and psychological changes that can significantly impact the quality of life for women. Menopausal symptoms such as hot flashes, sleep disturbances, mood swings, and reduced bone density can adversely affect the physical and mental health of women. There is a growing recognition that structured exercise programs may offer a non-pharmacological approach to mitigating these symptoms and improving overall health. Aerobic exercise has shown promise in mitigating these symptoms and improving overall quality of life. The study is particularly relevant in the context of Bhopal, as there is a dearth of research specifically addressing the impact of structured exercise programs on the quality of life of menopausal women in this region. Investigating this aspect is crucial for developing region-specific interventions and recommendations Despite the existing body of literature on exercise interventions and menopause, there remains a need for rigorous empirical evidence, especially through randomized controlled trials. This study aims to contribute to the scientific understanding of the efficacy of structured exercise programs in enhancing the quality of life during the menopausal transition. The study aligns with the global shift towards promoting holistic approaches to women’s health. By focusing on quality of life outcomes, including physical, psychological, and social well-being, the research acknowledges the interconnected nature of these factors during the menopausal phase. Findings from this study could have implications for public health policies and interventions aimed at improving the quality of life for menopausal women. If the structured exercise program is proven effective, it could be integrated into community health initiatives, promoting a proactive and preventive approach to women’s health. In conclusion, this study addresses a critical gap in the existing literature, offering a methodologically rigorous investigation into the impact of a structured exercise program on the quality of life among menopausal women in Bhopal. The findings have the potential to inform evidence-based interventions that could significantly contribute to the well-being of women during this life stage. 

RESEARCH QUESTIONS: Does a structured aerobic exercise program impact the quality of life in menopausal women? 
OBJECTIVES: â–ª To assess the existing menopausal quality of life among menopausal women. â–ª To compare the menopausal quality of life between the interventional group and a control group. â–ª To find out the association of selected sociodemographic variables with menopausal quality of life among menopausal women. 
HYPOTHESES: H0: There is no significant difference in the menopausal quality of life scores between the intervention group and the control group of postmenopausal women. 

OPERATIONAL DEFINITIONS: 
• Effect: in my study it refers to the extent to which structured aerobic exercise program has an impact on the quality of life among menopausal women, as assessed by difference in pre and post menopausal specific Quality of Life scores

Structured exercise program: A structured aerobic exercise program refers to a planned and organized regimen of physical activities designed to improve quality of life in menopausal women, it includes continuous, rhythmic movements that engage large muscle groups like walking, jogging, aerobic dance with defined frequency, intensity, and duration. 

• Menopausal quality of life: The subjective assessment of an individual’s overall wellbeing, encompassing physical, emotional, and social dimensions measured using the Menopause-Specific Quality of Life questionnaire. • 

Menopausal women: are women who have undergone permanent cessation of menstrual periods for at least 12 consecutive months confirmed through self-reporting and/or medical verification, such as clinical records or physician confirmation.

DELIMITATIONS: this study is only delimited to selected areas of Bhopal. 
MATERIALS AND METHODS • 
Research approach and design: quantitative, true experimental, randomized controlled trial 
Research variables: Independent variable: structured aerobic exercise program Dependent variable: quality of life
Research setting: selected areas of Bhopal 
POPULATION 
Target population: menopausal women of Bhopal  
Accessible population: menopausal women residing in a specific geographic location or community of Bhopal 
 SAMPLE  
Inclusion criteria: 
Women aged 45-60 years. 
Confirmed menopausal status. 
Willingness to participate and provide informed consent. 
Exclusion Criteria: 
Having cardiovascular or musculoskeletal conditions. 
Participation in any other structured program/exercise. 
Medical conditions contraindicating aerobic exercise. 
Sample size: �’� = 4𝛿²/𝐸² Here: �’� = sample size per group 𝛿 = the expected effect size (difference in means) 𝐸 = the margin of error or precision Sample size is 45 in each group i.e 90 participants approximately. Actual sample size will be calculated after pilot study.
Sampling technique: Convenient sampling then randomization will be done by 1:1 allocation, with the help of sequentially numbered opaque sealed envelope (SNOSE). 
DATA COLLECTION TOOL/INSTRUMENTS • Description of tools: Socio demographic data sheetA self structured tool will contain item like age, marital status, education, occupation, family income, residence, type of family, dietary pattern. Menopause-Specific Quality of Life (MENQOL) Questionnaire: The MENQOL questionnaire is specifically designed to measure the quality of life in menopausal women. It includes domains such as vasomotor, psychosocial, physical, and sexual symptoms associated with menopause. The MENQOL questionnaire typically consists of 29 items, and respondents rate the impact of menopausal symptoms on different aspects of their life using a Likert scale. The questionnaire covers four specific domains: 1. Vasomotor Symptoms: This domain focuses on symptoms such as hot flashes and night sweats. 2. Psychosocial Symptoms: This domain assesses the impact of menopause on mood, anxiety, and overall psychological well-being. 3. Physical Symptoms: This domain addresses physical symptoms associated with menopause, such as joint and muscle pain. 4. Sexual Symptoms: This domain evaluates the impact of menopausal symptoms on sexual function and satisfaction. Each item in the questionnaire is scored on a scale from 0 to 6, with higher scores indicating a greater negative impact on quality of life. The scores from each domain can be analyzed separately or combined to provide an overall assessment of the impact of menopausal symptoms on a woman’s quality of life. The MENQOL questionnaire is a valuable tool for researchers and healthcare professionals seeking to understand the specific challenges and experiences of women going through menopause. It has been translated into multiple languages and has been used in various cultural contexts. When using the MENQOL questionnaire, researchers should follow guidelines for administration and scoring provided by the developers to ensure accurate and reliable results. 
Validity of tools: the tool will be verified by the experts from the field of Obstetrics and Gynaecology, and nursing. 
Reliability of tool: MENQOL scale had a high internal consistency of 0.90 Ethical consideration: Written permission will be taken from the concerned authority; ethical clearance will be taken from, The institutional human ethical committee,IHEC-SR & informed consent will be taken from the subject. 
PROCEDURE OF DATA COLLECTION: After getting ethical consideration and subjects consent. • The data will be collected for a period of 6-8 weeks.
It will be collected from the Accessible population: Randomization of participants will be done by using SNOSE, pre test taken from both groups and after that structured exercise program will be administered to interventional group (40 min aerobic exercise, 4 times a week) for 6 weeks. Post test will be taken after completion of 6 weeks of intervention.
PLAN FOR DATA ANALYSIS: Analysis will be done using descriptive & inferential statistics. 
Descriptive statistics: frequency and percentage distribution to analyse the socio-demographic variables in experimental and control group. â–ª Mean and standard deviation will used to compare outcomes between the exercise group and a control group. 
Inferential statistics: unpaired t test will used to compare outcomes between the exercise group and a control group with routine activities â–ª Chi square test will be used to find association between selected socio-demographic variable and structured exercise program. â–ª The analysed data will be presented in the form of tables, diagrams and graphs. 
SUMMARY: This study aims to investigate the effect of a structured aerobic exercise program on the quality of life in menopausal women. The study employs a randomized controlled trial design, with menopausal women randomly assigned to either the intervention group participating in a carefully structured aerobic exercise program or a control group. The intervention group engages in regular sessions of aerobic exercises, including walking, jogging, etc. with a defined frequency and duration. The control group maintains their usual lifestyle without participating in any structured exercise program. Validated quality of life assessment tools, such as the Menopause-Specific Quality of Life (MENQOL) questionnaire, are employed to measure outcomes. Baseline data, including demographic information and initial quality of life assessments, are collected before the intervention begins. Throughout the study, researchers monitor adherence to the exercise program, track any potential adverse events, and gather follow-up data at specified intervals. Blinding procedures are implemented where feasible to minimize bias. The hypothesis posits that women in the intervention group engaging in aerobic exercise will experience a statistically significant improvement in overall quality of life compared to the control group. 

 
Close