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.: PACTR202403566263718 Date of Approval: 22/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Pilates exercise versus aerobic exercise on metabolic syndrome in premenopausal women.
Official scientific title Effect of Pilates exercise versus aerobic exercise on metabolic syndrome in premenopausal women.
Brief summary describing the background and objectives of the trial Metabolic syndrome is a cluster of metabolic abnormalities that increases cardiovascular risk. Insulin resistance and central obesity are considered important factors. Lipid and lipoprotein abnormalities play a major role in the development and progression of coronary artery disease. Pilates improves serum lipid profiles, blood pressure, and inflammatory markers, as well as reducing the risk of stroke, acute coronary syndrome, and overall cardiovascular mortality. Aerobic exercise is efficacious for increasing high-density lipoprotein and decreasing total cholesterol, low-density lipoprotein, and triglyceride in women. The purpose of this study is to compare the effect of Pilates exercise versus aerobic exercise on metabolic syndrome in premenopausal women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Mets
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 23/03/2024
Actual trial start date 28/03/2024
Anticipated date of last follow up 23/06/2024
Actual Last follow-up date 28/06/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://cu.edu.eg/Home
Secondary Ids Issuing authority/Trial register
No: P.T.REC/012/004865
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pilates exercise and lifestyle modifications. one hour three times per week 12 weeks. 20 premenopausal women with metabolic syndrome will receive Pilates exercise. Each session includes three phases: Warming up (7–10) minutes warm-up phase in the form of breathing, arm circles, and hip rolls exercises The Pilates phase was 40 minutes long and consisted of 5 types of exercises (bent knee, shoulder bridge, side kick front, side kick back, single leg circle). The duration of each one was 7-8 minutes. - Cool down (7–10) minutes in the form of (neck stretch, knee stretch, breathing exercises). 20
Experimental Group aerobic exercise and lifestyle modifications. half-hour, 3 instances per week for 12 weeks. 20 premenopausal women with metabolic syndrome will receive The treadmill exercise program will start with a warm-up period in which each female will walk at 80 m/min at 0.0% grade for 5 minutes. After that, the treadmill speed will be increased to 147 m/min, and its grade will gradually increase until it reaches 25% for 20 minutes. After that, there will be a cool-down phase, during which the treadmill's speed and grade will be lowered to 2.0 miles per hour and 0.0%, respectively. 20
Control Group lifestyle modifications 12 weeks 12 weeks lifestyle changes such as losing body weight, adopting a healthy diet, quitting smoking and drinking alcohol in moderation 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) All women having metabolic syndrome criteria : • elevated waist circumference >80 cm. • elevated triglycerides ≥150 mg/dl. • reduced high density lipoprotein cholesterol (HDLC) <50mg/dl, • elevated blood pressure > 130 mmHg systolic or >85 mmHg diastolic. • Elevated fasting glycemia ≥ 100 mg/dl. (Huang ,2009). 2) Their ages will range from 35-45 years. 3) Body mass index (BMI) will be 30-35 kg/m2. 1) Any history of injury. 2) Musculoskeletal, systemic, or neurological disorders. 3) Receive any exercise training within 6 months directly before the study. 4) specific medical problems in which treatments such as drugs will influence the effect of exercise (history of cancer, hemodialysis treatment, and coronary heart disease). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 08/10/2023 PT REC
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat st. BienElsarayat,Dokky,Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Lipid profile: high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol (TC), triglycerides (TG). at the beginning of the study and after the end of 12 weeks
Secondary Outcome • Blood pressure. • Waist circumference (WC). at the beginning of the study and after the end of 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinics of Asyut university University street Asyut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Thoria Hassan Thabet Abad Alrahman st Asyut 71772 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy University street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hossam El Deen Hussein kamel cairo cairo 11725 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Thoria Hassan Thabet boodywalid14@gmail.com 01026926410 Abad AlRahman ST.
City Postal code Country Position/Affiliation
Asyut 71772 Egypt Assistant Lecturer Sphinx University
Role Name Email Phone Street address
Public Enquiries Hossam Eldeen Hussien hossameldinsalem.2062@azhar.edu.eg 01223141816 336 Tarat el Gabl Al Mataria
City Postal code Country Position/Affiliation
cairo 4540046 Egypt Professor of obstetrics and gynecology Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Abeer ElDeeb beroeldeeb@yahoo.com 01001811588 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza
City Postal code Country Position/Affiliation
Giza 12613 Egypt Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: “Yes” Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in premenopausal women with metabolic syndrome. 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. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication, and the data will be made accessible for up to 24 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
https://pt.cu.edu.eg/ar/ 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