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CTRI Number  CTRI/2024/04/065311 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Exercises during pregnancy 
Scientific Title of Study   Effectiveness of Tele Physiotherapy exercise as Compared to home exercise program on Quality of life and Sleep Quality in Antenatal period 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  Meghna Ugale 
Designation  PG Student 
Affiliation  Pravara Institute of Medical Sciences. 
Address  Community Physiotherapy Department Dr. APJ Abdul kalam College of physiotherapy,Loni pravara Institute of Medical Scciences,loni, Ahmadnagar

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9588467665  
Fax    
Email  meghnaugale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nupoor Kulkarni 
Designation  Phd,Community Physiotherapy Department 
Affiliation  Pravara Institute of Medical Sciences. 
Address  Community Physiotherapy Department Dr. APJ Abdul kalam College of physiotherapy,Loni pravara Institute of Medical Scciences,loni, Ahmadnagar

Ahmadnagar
MAHARASHTRA
413 736
India 
Phone  7588009062  
Fax    
Email  nupoor.kulkarni22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nupoor Kulkarni 
Designation  Phd,Community Physiotherapy Department 
Affiliation  Pravara Institute of Medical Sciences. 
Address  Community Physiotherapy Department Dr. APJ Abdul kalam College of physiotherapy,Loni pravara Institute of Medical Scciences,loni, Ahmadnagar

Ahmadnagar
MAHARASHTRA
413 736
India 
Phone  7588009062  
Fax    
Email  nupoor.kulkarni22@gmail.com  
 
Source of Monetary or Material Support  
Community physiotherapy Department Dr.APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences,Loni Ahamadnagar, Maharashtra, 413736 
 
Primary Sponsor  
Name  DR APJ Abdul Kalam Collage of physiotherapy 
Address  Community physiotherapy Department Dr.APJ Abdul Kalam Collage of Physiotherapy Pravara Institute of Medical Sciences,Loni Ahamadnagar, Maharashtra, 413736 
Type of Sponsor  Private medical college 
 
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 
DrMeghna Ugale  Community physiotherapy Department  Assessment will be done in Community physiotherapy department,Dr APJ Abdul Kalam college of physiotherapy Pravara Institute of Medical Sciences,Loni Ahmadnagar Maharashtra Intervention given in virtual mode,telecommunication.
Ahmadnagar
MAHARASHTRA 
9588467665

meghnaugale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Antenatal Women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  home exercise program program  total duration-6 months frequency-3 weeks,3 times in 1 week 2nd trimester exercises Relaxation techniques Deep breathing exercises Labour education Gluteus isometrics Quadriceps isometrics Stretching calf and hamstring Pelvic bridging Alternate arm leg raise 3rd trimester exercises Relaxation techniques Deep breathing exercises Labour education Stretching Squatting Kegel’s exercises Walking.  
Intervention  Tele Physiotherapy exercise program   total duration- 6 months frequency- 3 weeks,3 times in 1 week. 2nd trimester exercises Relaxation techniques Deep breathing exercises Labour education Gluteus isometrics Quadriceps isometrics Stretching calf and hamstring Pelvic bridging Alternate arm leg raise 3rd trimester exercises Relaxation techniques Deep breathing exercises Labour education Stretching Squatting Kegel’s exercises Walking  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  34.00 Year(s)
Gender  Female 
Details  Participants included will be:
Ante Natal females in 2nd an d 3rd trimester.
Age 18 to 34 yrs.
Participants are aware of telecommunication technology such as video conferencing or telephone meeting,
4 .audio call or video call to facilitate management of patients within their own homes
 
 
ExclusionCriteria 
Details  Participants excluded will be:
High Risk of Pregnancy. -Higher-order multiple pregnancies (e.g., twins, triplets etc.)
Uncontrolled high blood pressure,
Uncontrolled type 1 or type 2 diabetes
Uncontrolled thyroid disease
-Other serious cardiovascular, respiratory or systemic disorders

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
GET Active Questionnaire For Physical activity.

Health questionnaire EQ-5D-5L, For Quality Of Life.

Pittsburgh Sleep Quality Index.
 
Week 0
week 6

 
 
Secondary Outcome  
Outcome  TimePoints 
GET Active Questionnaire For Physical activity.  Week 0
week 6 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/04/2024 
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)  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  

INTRODUCTION

  The term "antenatal period" refers to the time from the beginning of the pregnancy to the onset of labour; "maternity medical services" refers to all primary medical care related to pregnancy, excluding intrapartum care, for female patients (apart from babies); and any primary medical care required for babies during their first 14 days of life. Changes in Physiology During Pregnancy.

Physiological Changes During Pregnancy are, The Heart and Circulatory System The main changes that occur during pregnancy are an increase in uteroplacental blood flow, a decrease in peripheral resistance, a rise in cardiac output, and an expansion of plasma volume, with the rate of change peaking between weeks 24 and 28. Estradiol, progesterone, hCG, relaxin, and the growth factors vascular endothelial growth factor (VEGF) and placental growth factor (PIGF), along with the local effect on uterine blood vessel architecture towards expansion and dilatation, are the hormones that cause these changes to manifest Preload increases and afterload decreases as a result of the shift in calculable indices. In the primary clinical context, this results in a decrease in during the first and second trimesters of pregnancy, blood pressure decreases by 5–10 mmHg, and during the third trimester, blood pressure recovers to normal. An associated process that is most noticeable in the second trimester is the rise in erythrocyte production, which is brought on by the kidneys producing more erythropoietin. All of these modifications lead to the placenta and the fetus receiving nutrition and oxygen in turn. Due to the contraction of muscles and an overall increase in cardiac output, all of them function at or above the level of moderate physical activity and are even enhanced by it. This is because the fetus receives more oxygen from the placental bed. It has been demonstrated that pregnancy and exercise increase maximal oxygen consumption (VO2Max). Between 5% and 10%. (2) An second adaptation brought on by physical exercise is a supposedly higher exchange rate across the placenta, which accelerates placental cell proliferation. The second part of pregnancy is a diabetogenic period, since peripheral tissues, including muscle and fat, become relatively resistant to insulin. Insulin resistance is impacted by a number of hormones that are produced in significant amounts during pregnancy. These include prolactin, cortisol, human placental lactogen, estradiol, and progesterone, in increasing order of potency. pregnancy-induced insulin resistance appears to be advantageous to the fetus since it increases the amount of glucose accessible for diffusion across the placenta to the fetus when the mother’s blood glucose content rises and her glucose utilization decreases. On the other hand, due to a competitive increase in muscle glucose uptake, exercise appears to decrease fetal glucose availability. Pregnancy-related physical exercise has been linked to several benefits, including a decreased risk of gestational hypertension, gestational diabetes mellitus, lower back pain, cesarean birth, and an increased likelihood of a straightforward, uneventful delivery.(3) International recommendations advocate engaging in physical activity (PA) for at least 150 minutes each week.  Nowadays, sedentary lifestyles account for more than half of the time spent by pregnant women. Between the diagnosis of pregnancy and three months after giving birth, there is a significant drop in physical activity. During their pregnancy, up to 58% of women do not meet the required threshold for physical exercise. Pregnancy remains an appropriate period to support a healthy lifestyle as pregnant women are more responsive to health messaging . The primary focus of healthcare providers should be on implementing treatments to encourage physical exercise throughout a pregnancy,(1). In the absence of medical or obstetric difficulties, the American College of Obstetricians and Gynecologists (ACOG) advises all pregnant women to participate in moderate exercise for 30 minutes or more every day on most, if not all, days of the week. One behavioral element that is well-established for controlling weight in the non-pregnant population is exercise.  There is little and inconsistent data about the impact of exercise on managing weight gain during pregnancy. Physical activity during pregnancy has been shown in several observational studies to have a significant protective impact against excessive gestational weight gain.(4) When an in-person visit is not practical, telephysiotherapy (TPT) is the delivery of physiotherapy treatments remotely via telecommunication technology such as video conferencing or telephone meetings . TPT uses video or audio calls as a form of communication technology to let patients receive physiotherapy in the comfort of their own homes. Clinically, TPT includes a variety of services related to rehabilitation and habilitation, such as education, consultation, counseling, assessment, monitoring, prevention, intervention, and supervision. Due to travel time and expense, patients who reside far from the clinics may find it challenging to visit on a regular basis. TPT, which uses telecommunications technology as a means of informing patients about therapeutic exercises to perform at home when they are far from physiotherapy clinics, should be taken into consideration as a solution to these issues. TPT is therefore a practical means for patients to carry out basic physiotherapy without having to travel vast distances. Individuals work out in their own environment. In addition, physical therapists could keep an eye on the parameters of the exercises and make any necessary adjustments or advancements via TPT. Patients who live in remote places benefit from the TPT in addition to time and cost savings. Without TPT, patients may have to stop receiving physiotherapy, which could lead to poor health outcomes and inadequate treatment, ultimately worsening their quality of life (QoL) . Even though TPT may have numerous drawbacks and obstacles, a well-chosen patient pool, effective interventions, a communication medium, supportive caretakers or medical staff, and a prearranged timetable would all contribute to TPT’s effectiveness.(5)

 

 

 

Need for the study: During pregnancy, women undergo major changes in their body mechanics, physiology, and psychology. It is characterized by severe anterior pelvic tilt and lumbar curve changes due to fetal growth and an increased abdominal size.  Later stages are characterized by tension in the hip flexors and lumbar muscles, and weakening of the abdominal and hip joint muscles. These eventually lead to pelvic pain, thus resulting in body instability and low back pain In addition to the stress caused by the physical changes, the psychological anxiety among pregnant women. So, to reduce the effects of  physical ,psychological changes in  antenatal females , so its need to physical activity and exercises.  So need arises for assessing Effectiveness of TelePhysiotherapy exercise as Compared to home exercise program in antenatal females.

 

Research Question:

What will be the effect of TelePhysiotherapy exercise as Compared to home exercise program on Quality of life and Sleep Quality in antenatal period?

Aim and Objectives of the study:

Aim:

AIM: To Compare the effectiveness TelePhysiotherapy exercise as Compared to home exercise program on Quality of life and Sleep Quality in antenatal females

 

Objective: To find out the Quality Of Life and Sleep Quality in antenatal females.

 

 

Hypotheses:

Null Hypothesis (H0):  There will be no significant difference between telePhysiotherapy exercises as compared to home exercise program on Quality of life and Sleep Quality among females in Antenatal period.

 

Alternative Hypothesis (H1):  There will be significant difference between telePhysiotherapy exercises as compared to home exercise program on Quality of life and Sleep Quality among females in Antenatal period.

 

 

 

MATERIAL AND METHODOLOGY:

Source of Data:  Pravara Rural Hospital, Loni

Study setting:  The study will be conducted at department community Physiotherapy, Dr .A.P.J Abdul Kalam college of physiotherapy, Loni.

Study Duration: 2 years

Method of collection of data: Data will be collected by the primary investigator.

Type of Data: Quantitative data

Study Design:  Randomized controlled trial

Sample size: 60

Sampling Method: Simple random sampling

Material to be used:

1. Consent form

2. Assessment sheet

3.Pen

SELECTION CRITERIA:

Inclusion criteria:

Participants included will be:

Ante Natal females in 2nd an d 3rd trimester.

Age 18 to 34 yrs.

Participants are aware of   telecommunication technology such as video conferencing or telephone meeting,

audio call or video call to facilitate management of patients within their own homes.

 

Exclusion criteria:

Participants excluded will be:

 High Risk of Pregnancy. 

Higher-order multiple pregnancies (e.g., twins, triplets etc.).

Uncontrolled high blood pressure, type 1 or type 2 diabete, thyroid disease.

Other serious cardiovascular, respiratory or systemic disorders.




Outcome Measures:

Outcome measures used for this study will be as follows,

 GET Active Questionnaire For Physical activity.

 Health questionnaire EQ-5D-5L, For Quality Of Life.

Pittsburgh Sleep Quality Index.



Procedure

Protocol is prepared and ethical clearance will be obtained from the IEC.

The Participants will be selected based on the eligibility criteria.

Informed consent will be obtained from the participants and demographic data will be  recorded.

Participants will be randomly allocated to 2 groups that is intervention group (n=30) and Conventional group(n=30). Prior assessment of the participants will be done.

intervention group will be telephysiotherapy exercises and conventional group will be  home exercises   program is given in antenatal females

All the instructions will be given verbally, provided demonstration and guided through a single practice trial.



REFERENCES:

p james, et al. “How to promote physical activity during pregnancy : A systematic review. https://doi.org/10.1016/j.jogoh.2020.101864.

 Mor R,et al. ‘Physical Activity During Pregnancy: Physiological Considerations and Physical Activity During Pregnancy: Physiological Considerations and Practical Guidelines https://doi.org/10.18103/mra.v10i4.2753

Fred K,et al. Exercise and Pregnancy Hormonal Considerations Edited by: M. P. Warren and N.W. 

Shericka T,et al Exercise During Pregnancy and its Association with Gestation Weigh Gai Matern Child Health J DOI 10.1007/s10995-014-1534-8.

Shambhu P. Adhikari, et al Feasibility and Effectiveness of Telephone-Based Telephysiotherapy for Treatment of Pain in Low-ResourcSetting: A Retrospective Pre-Post Design https://doi.org/10.1155/2020/2741278.

 Ah-Hyun Hyun, et al Effect of Home-Based Tele-Pilates Intervention on PregnantWomen:APilotStudy. https://doi.org 10.3390/healthcare10010125

 Esra UZELPASACI et al  Telerehabilitation for Exercise Training in Pregnancy. DOI:10.21613/GORM.2022.1306



 
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