Comparing the effect of tailored exercise programs and conventional exercise on sleep quality and well being in perimenopausal women A Randomized controlled trial

INTRODUCTION

Perimenopausal period refers to the period from the onset of endocrine biological and clinical features associated with menopause near menopause to within  year of menopause During this period due to the decline of ovarian function the level of estrogen progesterone decreases in a clifflike manner the number and quality of oocytes decrease and the levels of estrogen and progesterone continuously decline Some women in this period may not only be prone to menstrual disorders hot flashes sweating insomnia palpitations vertigo fatigue headache frequent urination and muscle aches throughout the body pain and discomfort in the bone and joint parts of the body emotional instability and other physiological symptoms but also easily associated with anxiety depression and other mental disorders

During the perimenopausal period hormonal fluctuations occur and there is a challenging transitional time for womens wellbeing and health The perimenopause is related to various biopsychosocial changes and some women may have physical and psychological symptoms of different severity Although various symptoms are not lifethreatening they may have a negative influence on the subjective wellbeing of perimenopausal women Sleep quality was impacted by both menopausal symptoms and hormone levels  Poor sleep quality is among the most common health problems that are reported by perimenopausal women throughout their reproductive life cycle

NEED FOR THE STUDY

Prevalence of sleep disturbances and mental health issues in perimenopausal women Perimenopause the transition phase before menopause  is marked by hormonal fluctuation declining estrogen and progesterone that significantly affect sleep patterns and mental well being Studies indicated that  of perimenopausal women experience sleep disturbances such as insomnia  night sweats and fragmented sleep Mood disorders including anxiety and depression are more prevalent in this population due to hormonal and physiological changes

Limitation of current management strategies   Hormonal replacement therapy HRT is often prescribed but has risks eg increased chances of breast cancer  blood clots Pharmacological sleep aids eg benzodiazepines melatonin mat lead to dependency and side effects like drowsiness and cognitive impaiement Non  pharmacological interventions such as cognitive behavioral therapy CBT  and lifestyle modification show promise but require further study

Potential of exercise as a non pharmacological intervention  Exercise is know to improve sleep  quality regulate circadian rhythms and reduce stress by increasing serotonin and endorphinsRegular physical activity has been linked  to reduced depressive symptoms anxiety and fatique in women undergoing hormonal transition Trailored exercise programs combining aerobics  resistance and mindfulness based exercises  could  address both physical and psychological symptoms effectively

 RESEARCH QUESTION

What will be the Effect of tailored exercise programs and conventional exercise on sleep quality and mental well being in women with perimenopause

AIM AND OBJECTIVESs

AIM

To find the Effect of tailored exercise program vs conventional physiotherapy exercises on sleep quality and well being in perimenopausal women

OBJECTIVES

To determine the effectiveness of tailored exercise programs in improving sleep quality using Pittsburgh sleep quality index PSQI

To assess changes in mental well being following the intervention using warwick Edinburgh mental well being scale WEMWBS

 Hypotheses

Null Hypothesis H

There is no significant difference in the tailored exercise program and conventional exercise on sleep quality and well being in perimenopausal women

Alternative Hypothesis H

There is significant difference in the  tailored exercise program and conventional exercise on sleep quality and well being in perimenopausal women

 MATERIAL AND METHODOLOGY

Study Setting  Department of  Community Physiotherapy Dr APJ Abdul Kalam college of physiotherapy Loni

Study Type Experimental study

Study Design Randomized controlled trial

Study Duration  years

Source of data  Obstetrics and gynecology OBGYN OPD PMT Loni

Sampling Method Simple Random Sampling

Sample size

OUTCOME MEASURES

 Outcome measures used for this study will be as follows

Pittsburgh sleep quality index PSQI

Warwick  Edinburgh mental well being scale WEMWBS

ELIGIBLITY CRITERIA

Inclusion criteria

Women present with amenorrhea for at least  months

Be able to understand and carry out the instruction

Women age range   years consisting with the typical perimenopausal phase

To be able to ambulate without assistance

To be able to communicate

 Exclusion criteria

Patient undergoing Hormonal replacement therapy

Suffering from some type of systemic disease eg neurodegenerative musculoskeletal and vision

Taking drugs that affects the central nervous system  balance or coordination eg antidepressants vestibular sedatives or anxiolytics

Myocardial infarction in the past  months

Unwillingness to either complete the study requirement or to  be randomized into control or intervention group

   PROCEDURE

All the subjects will be explained about the study and written inform consent form will be signed by each one of them

Then simple random sampling will be done for distribution of data Number of participants into  groups Group A was control group Group B was intervention group Then pre assessment will be done on patients

Target population will be perimenopausal women  of  to  years of age and will be taken from Pravara Rural Hospital LONI Participants were screened based on inclusion and exclusion criteria and those willing to participate will be included in this study

Pittsburg sleep quality index PSQI r v

The Pittsburgh sleep quality index PSQI is a widely used standardized questionnaire designed to assess sleep quality and disturbances over the past one month It helps to identify individuals with poor sleep quality and is commonly used in clinical research settings including perimenopausl sleep disturbance The PSQI consist of  selfrated questions grouped into  components each score ranges from  to  The total PSQI  score ranges from  to  with higher scores indicating worse sleep quality

Warwick  Edinburgh mental well being scale WEMWBSr  v

The Warwick Edinburgh mental well being scale WEMWBS is a validated tool designed to measure mental wellbeing  focusing on positive mental health rather than mental illness It assesses psychological functioning  emotional wellbeing and life satisfaction  self reported items measuring positive mental health  Each item is rated on a  points likert scale    none of the time   all of the timeIt covers aspects like optimism relationships confidence relaxation and energy levels Total score ranges   higher score indicates better mental well being Interpretation   low well being possible psychological distress

moderate mental well being

high mental well being

                                                                                                                                            INTERVENTION

Group A is  control group in this group particiopants randomly assigned to the usual care  and will receive general advices from primary care centre medical staff about positive effects of physical activity

General health and patient education

Hormonal and physiological changes  Declining estrogen and progesterone levels affects sleep  mood  metabolism and bone density

Increased risk of osteoporosis  cardiovascular disease and metabolic syndrome

Lifestyle modifications

Diet  Increased calcium and vitamin D for bone health  Consume phytoestrogens soy  flaxseeds to help with hormonal balance Limit caffeine alcohol  and processed foods that may worsen symptoms

Sleep hygiene  maintain a consistent sleep schedule Avoid blue light exposure before bedtime Practice relaxation technique like deep breathing

 Group B was intervention group in this group participants were given aerobics exercises resisitance training along with mindfulness based exercises Each exercise session included  mins of warm up exercises  minutes of aerobics exercises and  minutes of cool down exercises The aerobics exercises included jumping jacks butt kicks  jump rope lunges Aerobics exercises were done  times per week The exercises was done with moderate intensity   max HR

 For resistance training  resistance training was done it mainly focus on major muscle groups using body weight  resistance  band  light weight These  sessionsweek  will be taken  The exercises to be done are squats  push ups  planks

 For mindfulness based exercises yoga and jacobsons relaxation technique will be taught for  minutes  sessions per week will be done

    Statistical Analysis

 Does the study require any interventions or investigations to be conducted on patients or other human or animals If so please describe briefly

Yes on patients

Has ethical clearance been obtained from your institution in case of

Referred for ethical clearance