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IRCT20100414003706N37 IRCT 2020-09-07 Tabriz University of Medical Sciences Effect of exercise on pregnancy outcomes Compliance of supervised and home-based exercises during pregnancy and effects of the exercises on some maternal, fetal and neonatal outcomes 2020-09-05 anticipated 150 Complete https://irct.ir/trial/49747 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be allocated into three study groups (supervised or home-based exercise, control with no intervention). Allocation sequence will be generated by a person, not involved in the recruitment and data collection, through individual stratified (based on 1st or 2nd-3rd pregnancy) block randomization with random block sizes of six and nine, and allocation ratio of 1:1:1 using a computer program. The sequence will be concealed using sequentially numbered opaque sealed envelopes. N/A Exercise during pregnancy. Intervention 1: Intervention group1 (supervised exercise): the women will exercise three 30-60 min sessions per week from 12-18th to 38th week of gestational age, adapted to the pregnancy trimesters. One to two of the sessions each week will be under direct guidance of a trained person (in person or in groups of 1-4 persons) while looking at a video tap, and the other one to two sessions will be under indirect supervision (through phone call at the start of each session and 1-2 calls during or end of the sessions). Intervention 2: Intervention group 2 (home-based exercise): following 1-2 educational sessions of the exercises at two time-points (12-18 and 26-28 weeks of gestational age), the video exercise tap will be given to the participants and they will be instructed to adhere to the prescribed aerobic exercise program and have regular exercise (at least three times a week, 30-60 min/session) at home, they will be reminded by sending a short message at the start of each session) and their performance will be monitored via phone calls once a week. All necessary instructions and precautions will be provided to the intervention groups both verbally and in written. Intervention 3: Control group: no intervention. Yes - There is a plan to make this available What will be shared: All deidentified IPD can be shared When: Starting soon after publication of the study results for ten years. To whom: Data will be available for researchers working in academic institutions, as well as to chief editor and reviewers of the submitted manuscript. Conditions: The data will be available to researchers upon request and submission of the proposal to perform meta-analysis using IPD. Also, in exceptional cases, data will be made available to chief-editor of the journals for checking. Where to obtain: Refer to the email addresses (alizades@tbzmed.ac.ir, a.veisy@yahoo.com) How to obtain: The requests should be sent by email and data will be available within two week. Comments:
public Afsaneh veisy
South Shariati Ave., Tabriz.
Tabriz Iran (Islamic Republic of) 5137975846 +98 41 3479 6770 a.veisy@yahoo.com Tabriz University of Medical Sciences scientific Sakineh Mohammad- Alizadeh - charandabi
South Shariati Ave., Tabriz.
TAbriz Iran (Islamic Republic of) 5137975846 +98 41 3479 6770 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Pregnant women in the 12th-18th weeks of pregnancy 1st to 3rd pregnancy Aged 18-40 years Having a singleton fetus with no known malformation No previous history of cesarean section No previous history of premature labour Be literate Iranian nationality of wife and husband 18 years 40 years Female Abnormal (unicorn / septum) uterus Incompetent cervix Cardiovascular or respiratory diseases Uncontrolled type I diabetes Chronic hypertension Symptomatic anemia Uncontrolled thyroid disease Shortness of breath before exercise and chest pain Orthopedic limitations Regular aerobic exercise longer than 30 minutes twice a week or more, during current pregnancy BMI > 35 Having suicidal thoughts Unwillingness or inability to attend exercise sessions regularly Severe back pain Y93.A3 Activity, aerobic and step exercise Lifestyle Lifestyle Other Intervention group1 (supervised exercise): the women will exercise three 30-60 min sessions per week from 12-18th to 38th week of gestational age, adapted to the pregnancy trimesters. One to two of the sessions each week will be under direct guidance of a trained person (in person or in groups of 1-4 persons) while looking at a video tap, and the other one to two sessions will be under indirect supervision (through phone call at the start of each session and 1-2 calls during or end of the sessions). Intervention group 2 (home-based exercise): following 1-2 educational sessions of the exercises at two time-points (12-18 and 26-28 weeks of gestational age), the video exercise tap will be given to the participants and they will be instructed to adhere to the prescribed aerobic exercise program and have regular exercise (at least three times a week, 30-60 min/session) at home, they will be reminded by sending a short message at the start of each session) and their performance will be monitored via phone calls once a week. All necessary instructions and precautions will be provided to the intervention groups both verbally and in written. Control group: no intervention Compliance rate of the aerobic exercises during pregnancy (average number and duration of exercise in a week). Timepoint: Two times (1- during 12-18 to 26-28, 2- during 26-28 to 36-38 weeks of pregnancy). Method of measurement: a diary form. Depression Score. Timepoint: At baseline, 26-28 weeks of pregnancy, and 6-8 weeks after delivery. Method of measurement: Edinburgh Depression questionnaire. Positive and negative affect Score. Timepoint: At baseline, 26-28 ،36-38 weeks of pregnancy, and 6-8 weeks after delivery. Method of measurement: Positive and Negative Affect Scale (PANAS). Birth weight. Timepoint: After delivery. Method of measurement: Hospital record. Anxiety score. Timepoint: At baseline, 26-28 weeks of pregnancy and 6 months after delivery. Method of measurement: Anxiety section of the Depression, Anxiety and Stress Scale (DASS-21). Well-Being Score. Timepoint: At baseline, 26-28 & 36-38 weeks of pregnancy and 6-8 weeks after delivery. Method of measurement: World Health Organization-Five Well-being Index. Fatigue score. Timepoint: At baseline, 26-28 weeks of pregnancy, 6-8 weeks and 6 months after delivery. Method of measurement: Multidimensional Assessment of Fatigue scale. Sexual function Score. Timepoint: At baseline, 26-28 weeks of pregnancy and 6 months after delivery. Method of measurement: Female sexual function questionnaire (FSFI). Low back pain score. Timepoint: At baseline, 26-38 & 36-38 weeks of pregnancy and 6-8 weeks and 6 months after delivery. Method of measurement: Visual analogue scale (VAS). Urgent and stress urinary incontinence Score. Timepoint: At baseline, 26-28 & 36-38 weeks of pregnancy and 6-8 weeks & 6 months after delivery. Method of measurement: Urinary Incontinence Diagnosis Questionnaire. Pregnancy weight gain. Timepoint: During pregnancy. Method of measurement: Using Prenatal record. Gestational age. Timepoint: At Birth. Method of measurement: Using date of last menstrual period or ultrasound report and birth date. Fear of childbirth. Timepoint: 36-38 weeks of pregnancy. Method of measurement: Wijma Delivery Expectancy (W-DEQ). Score of birth satisfaction. Timepoint: 6-8 weeks after delivery. Method of measurement: Iranian version of birth satisfaction scale-revised. Occurrence of Pregnancy complications (gestational hypertension or pre-eclampsia, gestational diabetes). Timepoint: 26-28 weeks and 36-38 weeks of pregnancy. Method of measurement: Prenatal record. Premature or preterm delivery. Timepoint: After delivery. Method of measurement: Using date of last menstrual period or ultrasound report and birth date. Cesarean section. Timepoint: After delivery. Method of measurement: Medical record. Childbirth trauma. Timepoint: After delivery. Method of measurement: Medical record. Postpartum weight loss. Timepoint: 6-8 weeks and 6 months after delivery. Method of measurement: Weight scale. Apgar score of the first and fifth minutes. Timepoint: First and Fifth minutes after birth. Method of measurement: Hospital record. Height and head circumference of infant. Timepoint: After birth. Method of measurement: Hospital record. Stress score. Timepoint: At baseline, 26-28 weeks of pregnancy and 6 months after delivery. Method of measurement: Stress section of the Depression, Anxiety, and Stress Scale (DASS-21). Tabriz University of Medical Sciences Approved 2020-08-01 Ethics committee of Tabriz University of Medical Sciences Third floor, Second centralbuilding, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)