Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201810729481551 Date of Approval: 08/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF AEROBIC EXERCISES ON THE THYROID HORMONES IN TREATED HYPOTHYROID PREGNANT WOMEN
Official scientific title EFFECT OF AEROBIC EXERCISES ON THE THYROID HORMONES IN TREATED HYPOTHYROID PREGNANT WOMEN
Brief summary describing the background and objectives of the trial Hypothyroidism is common during pregnancy; subclinical hypothyroidism (SCH) is present in up to 3% of all pregnant women; while overt hypothyroidism incidence is 0.3% to 0.5%. Subclinical hypothyroidism refers to asymptomatic individuals with elevated thyroid-stimulating hormone (TSH) and normal free thyroxin (FT4) levels. Overt hypothyroidism (OH) is defined as thyroid hormone deficiency with low free T4 (FT4) and elevated TSH levels (Stagnaro-Green and Pearce, 2012; Carney et al., 2014).The physiologic changes associated with pregnancy require an increased availability of thyroid hormones by 40% to 100% to meet the needs of mother and fetus during pregnancy (Soldin, 2006). The fetus is totally dependent on maternal thyroxine supply during the first trimester of gestation and up to mild gestation for normal neurologic development and nervous system maturation (Soldin, 2006). Subclinical hypothyroidism is associated with increased fetal distress, preterm delivery, poor vision development and neurodevelopmental delay. Overt hypothyroidism is associated with increased fetal loss, low birth weight and congenital circulation system malformations (Krassas et al., 2015). Fetal brain development is adversely affected with hypothyroidism (Haddow et al., 1999). Most studies have shown that children born to women with hypothyroidism during gestation had significantly lower scores in neuropsychological tests related to intelligence, attention, language, reading ability, school performance and visual motor performance (Krassas et al., 2015). The diagnosis of subclinical hypothyroidism usually relies on laboratory tests due to the lack of significant clinical features of subclinical diseases (Zhang et al., 2017). The TSH is a sensitive marker of thyroid dysfunction during pregnancy. Normal values have been modified recently, the upper normal range is now considered to be 2.5 mUI/mL in the first trimester and 3.0 mUI/mL for the remainder of pregnancy, This value of 2.5 mUI/mL wawas chosen because higher values are associated with higher fetal morbidity (Krassas et al., 2015). Given the deleterious impact of hypothyroidism on the health of the mother and fetus, it is important to maintain euthyroidism during pregnancy. As pregnancy increases the demand for production of thyroid hormones, maternal TSH levels should be titrated to ≤2.5 mIU/l with levothyroxine therapy (Stagnaro-Green and Pearce, 2012). After being euthyroid on hormone replacement, regular exercise can improve thyroid function and thus improve mental and physical status of hypothyroid patient and concomitantly decrease dose of thyroxine replacement therapy in non-pregnant subjects (Bansal, et al., 2015). Medium-intensity aerobic exercise produces the best results for improving TSH, it can improve thyroid function through better perfusion of the gland as TSH levels decreased, and T3 and T4 increased (Bansal et al., 2015). Therefore, this study aims to determine the effectiveness of aerobic exercises on the thyroid hormones in treated hypothyroid pregnant women. This study would be of valuable benefit for medical service organization and increase the knowledge of physical therapists to prevent adverse pregnancy outcomes related to hypothyroidism through improving the thyroid functions by aerobic exercises.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/11/2017
Actual trial start date 02/12/2017
Anticipated date of last follow up 14/09/2018
Actual Last follow-up date 30/11/2018
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group eltroxine doses thyroxine dose is 100 µg once a day. 12 weeks Each pregnant woman is taking medical treatment in the form of thyroxine replacement therapy doses (eltroxine); the thyroxine dose was 100 µg/day 21 Active-Treatment of Control Group
Experimental Group aerobic exercises three sessions per week i.e one every other day 12 weeks Each woman was instructed carefully before starting the treatment about the effect and nature of the exercises and instructed about the benefits of the exercises for the mother and fetus to obtain her confidence and cooperation. The exercise was performed as treadmill walking with zero inclination.Steps of the exercise program as described by Davies et al. (2003) & Ruchat et al. (2012): • Each woman was wearing light comfortable clothes then standing on the track belt grasping the handrails for increasing safety and comfort. • She was instructed to use the safety button if she feels any discomfort. • The therapist was standing beside the woman watching the graphics display to make sure, each woman was walking according to the desired intensity of modified heart rate target zones for aerobic exercise in pregnancy. The conventional age-corrected heart rate target zone is 140–155 beats/min for maternal age less than 20, 135-150 beats/min for maternal age 20-29 and 130-140 beats/min for maternal age 30-39 Each session for each woman in group (B) included: • Warming up: Each pregnant woman started the exercise with 5 minutes of warming up to prepare the skeletal muscles, heart and lungs for a progressive increase in intensity. • Stimulus phase: In the first week sessions, each woman was walking on treadmill for 15 minutes at target intensity according to modified heart rate target zones (130-140 beats/min) for aerobic exercise in pregnancy. Each subsequent week thereafter, the time at the prescribed intensity was increased by 2 min, until a maximum of 30 min was reached, this duration was maintained until the end of the study. • Cooling down: Each woman finished the exercise with 5 minutes of cooling down to gradually bring the heart rate down to its pre-exercise level. 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All women were paraI. • They were at 16 weeks’ gestation. • Their age were ranged from 25 to 35 years old. • Their body mass index (BMI) were ranged from 30 to 35 kg/m2 Women were excluded from this study if they had the following: • Orthopedic limitations, hypertension or multiple gestations. • Conditions that contraindicate exercise such as: uncontrolled type 1 diabetes, uncontrolled thyroid disease, other serious cardiovascular or respiratory disorders. • Taking medications except thyroxine replacement dose allover the study. Adult: 19 Year-44 Year 25 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/11/2017 the Faculty of Physical Therapy Research Ethics.
Ethics Committee Address
Street address City Postal code Country
El Tahrir St., Dokki, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome thyroid stimulating hormone TSH At starting of the study and after 12 weeks
Secondary Outcome Free T4 At starting of the study and after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KASR EL AINI HOSPITAL 27 Nafezet Sheem Ei Shafaey St., Caiiro Governorate Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menna allah mohamed abbas El Haram St. Giza Giza 12556 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor El Sherif Laboratory el Masala St., Fayoum Fayoum 63511 Egypt laboratory tests sponser
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator menna abbas menaabbas14@gmail.com 01118758578 El Haram St., Giza
City Postal code Country Position/Affiliation
Giza 12556 Egypt assistant professor in 6 october university
Role Name Email Phone Street address
Public Enquiries menna abbas menaabbas14@gmail.com 01118758578 El Haram St., Giza
City Postal code Country Position/Affiliation
Giza 12556 Egypt assistant professor in 6 october university
Role Name Email Phone Street address
Scientific Enquiries menna abbas menaabbas14@gmail.com 01118758578 El Haram St., Giza
City Postal code Country Position/Affiliation
Giza 12556 Egypt assistant professor in 6 october university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information