Skip to main content
Clinical Trials/CTRI/2024/04/065311
CTRI/2024/04/065311Not yet recruitingPhase 2/3

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.

DR APJ Abdul Kalam Collage of physiotherapy1 site in 1 country60 target enrollmentStarted: April 10, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
GET Active Questionnaire For Physical activity.

Study Overview

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:

Consent form

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.

 E****xclusion 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

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 34.00 Year(s) (—)
Sex
Female

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, 4 .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, Uncontrolled type 1 or type 2 diabetes Uncontrolled thyroid disease -Other serious cardiovascular, respiratory or systemic disorders.

Outcomes

Primary Outcomes

GET Active Questionnaire For Physical activity.

Time Frame: Week 0 | week 6

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

Time Frame: Week 0 | week 6

Pittsburgh Sleep Quality Index.

Time Frame: Week 0 | week 6

Secondary Outcomes

  • GET Active Questionnaire For Physical activity.(Week 0)

Investigators

Sponsor
DR APJ Abdul Kalam Collage of physiotherapy
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Meghna Ugale

Pravara Institute of Medical Sciences.

Study Sites (1)

Loading locations...

Similar Trials