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.: PACTR202305810673587 Date of Approval: 02/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative effects of different types of exercises on thyroid function and quality of life in patients with hypothyroidism
Official scientific title Comparative effects of different types of exercises on thyroid function and quality of life in patients with hypothyroidism
Brief summary describing the background and objectives of the trial Hypothyroidism is usually associated with reduction in metabolic function that most often manifests as a slowing of physical and mental activity. Exercises added to the treatment plan of hypothyroidism may potentially enhance the effects of medication, abate symptoms, and counteract disease progression. Physical activity has a regulating role on thyroid function. Several studies investigated the effect of aerobic exercise on hypothyroidism and revealed a significant increase in levels of thyroxine, triiodothyronine and some subscales of quality of life. Also, in hypothyroidism, resistance exercise elicits a milieu of physiological responses and adaptations that are critical for increasing muscular strength, power, hypertrophy and local muscular endurance. Moreover, combined aerobic and resistance exercises was significantly effective in hypothyroidism through reducing BMI and improving physical performance in patients with hypothyroidism. Aim/Objectives: This study has a number of clinical implications. This study is considered as a unique addition to the area of exercise training in hypothyroidism in order to reconcile differences in the findings of previous studies that looked at the influence of one kind of exercise on limited outcomes in hypothyroid individuals. This research gives healthcare practitioners who treat hypothyroid women more information about the effectiveness of different types of exercises. One factor for the inadequate referral of such patients to physiotherapy may be a lack of understanding about the benefits of exercise in such persons. Furthermore, various forms of exercise appear to be a low-cost intervention that requires little equipment. So,the aim of this study is to compare the effects of aerobic, resistance and combined training on thyroid function and quality of life in patients with hypothyroidism
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2022
Actual trial start date 29/01/2022
Anticipated date of last follow up 09/11/2022
Actual Last follow-up date 03/12/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group pharmacological treatment one daily. 12 Weeks It includes 15 patients participating in aerobic training plus pharmacological treatment. 15 Active-Treatment of Control Group
Experimental Group resistance training plus pharmacological treatment Low- to moderate- intensity aerobic training at (55 to 65 %) of maxHR 12 weeks 30 to 45 minutes of running. Also, there will be a 5-10 min warming-up and a 3-min cooling down 15
Experimental Group Progressive Resistance training Low- to moderate-intensity resistance exercise training at 55-65% of one repetition maximum (1RM). 12 weeks lateral pull down, bench press, biceps curls, abdominal crunch, leg press, hip abduction and calf raises exercises.5-10 minutes warming-up in the form of stretching and flexibility exercises. This is followed by the active phase (20-50 minutes) during which a 5-10 seconds passive rest will be allowed in-between repetitions (Muscle relaxation time will be> muscle contraction time) and 1-2 minute passive recovery will be permitted in-between sets. There will be also a cooling down phase for 5 minutes in the form of stretching exercises 15
Experimental Group Combined aerobic and resistance exercises Low to moderate intensity aerobic training at 55 to 65 % of HRpeak in combination with low to moderate intensity resistance exercise training at 55-65% of 1RM. 12 weeks The active phase of exercise will be from 20-25 aerobic exercise followed by 5 minutes of rest then 20-35 minutes of resistance exercises. Also, there will be a 5-10 min warming-up and a 5-min cooling down. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Female patients. 2- History of primary hypothyroidism (High TSH and low thyroid hormone level). 3- Controlled primary hypothyroidism (TSH between 0.2 to 4.6 mIU/L and free T4 between 0.8 to 1.8 ng/dL) in at least 6 months. 4- Their ages will be ranged from 35 to 45 years old. 5- They will be on thyroid hormone replacement therapy (e.g. Levothyroxine). 6- Their BMI will be from 25 to 35 Kg/m2. 7- All patients will be clinically and medically stable when attending the study. 1- Secondary hypothyroidism. 2- Subclinical hypothyroidism (High TSH, normal thyroid hormone level). 3- Thyroiditis. 4- Pituitary disease (Low TSH, low thyroid hormone level). 5- Unstable cardiovascular problems like arrhythmia and heart failure. 6- Diabetes. 7- Chronic chest disease. 8- Women on contraceptive pills. 9- Patients on medications affecting muscle power as steroids. 10- Peripheral vascular diseases. 11- Pregnancy & lactation. 12- Known patients with hypovitaminosis D or hypocalcemia or biotin supplements. Adult: 19 Year-44 Year 35 Year(s) 45 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 12/10/2021 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
Ahmed Elzayat Cairo 8655 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Thyroid hormones (TSH and T4): • Venous blood samples (5 ml) will be collected from each patient in all groups . • Medications affecting thyroid hormones should be stopped 3 days before the testing. • Serums of collected samples will separated from plasma by centrifuge pump in duration of 10 min before and after 12 weeks of the intervention
Primary Outcome The quality of life will be assessed using Short form health survey (SF-12). The SF-12 contains 12 items. All SF-12 items came from the SF-36. It includes eight dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health before and after 12 weeks of the intervention
Secondary Outcome Lipid parameters including Total Cholesterol, Triglycerides, HDL and LDL will be measured before and after 12 weeks of the intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Mahalla general hospital El Mahalla Alkobra - Bahr street El Mahalla Alkobra 31953 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
saher lotfy abo ali mahala 12611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Saher Elgayar Aboali Mahalla 12611 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
saher lotfy abo ali mahala 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saher Elgayar saherlotfy020@gmail.com +201020429911 Gehad
City Postal code Country Position/Affiliation
Mahalla 31951 Egypt Head of the team
Role Name Email Phone Street address
Public Enquiries Ahmad Mahdy ahmed.mahdy@pt.cu.edu.eg +201007056624 Giza street
City Postal code Country Position/Affiliation
Giza 12511 Egypt Coordinator
Role Name Email Phone Street address
Scientific Enquiries Hossam Ghazi saherelgayar@yahoo.com +201006408074 Bahr
City Postal code Country Position/Affiliation
Mahalla 34711 Egypt Sharing
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in hypothyroidism. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party Informed Consent Form,Statistical Analysis Plan Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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