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.: PACTR202101794912935 Date of Approval: 12/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF DIFFERENT AEROBIC EXERCISE PROTOCOLS ON BODY COMPOSITION IN OBESE WOMEN
Official scientific title EFFECT OF DIFFERENT AEROBIC EXERCISE PROTOCOLS ON BODY COMPOSITION IN OBESE WOMEN
Brief summary describing the background and objectives of the trial Obesity is a serious concern because it is associated with diabetes, heart disease, stroke, and some types of cancer. Obesity is a complex health issue to address and results from a combination of causes and contributing factors, including individual factors such as behavior and genetics. Behaviors can include dietary patterns, physical activity, inactivity, medication use, and other exposures. High-intensity interval training (HIIT) is a form of interval training, a cardiovascular exercise strategy alternating short periods of intense anaerobic exercise with less intense recovery periods, until too exhausted to continue. Low-volume HIIT is defined as ‘brief, intermittent bursts of vigorous activity, interspersed by periods of rest or low intensity exercise’, typically prescribed at a training intensity between 80 and 100% of heart rate maximum (HRmax).
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 DIFFERENT AEROBIC EXERCISE PROTOCOLS
Anticipated trial start date 10/01/2021
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group moderate intensity continuous exercises for 65 minutes/session. The protocol will require a working phase lasting 55 minutes (65 – 75% HRmax), in addition to the phases of 5 min warming up and 5 min cooling down. 2 months for 65 minutes/session. The protocol will require a working phase lasting 55 minutes (65 – 75% HRmax), in addition to the phases of 5 min warming up and 5 min cooling down. 20 Active-Treatment of Control Group
Experimental Group High intensity interval training for 33 minutes/session. The 4×4 HIIT protocol will require a working phase lasting 4 minutes (85 – 95% HRmax), repeated 4 times and separated by a 3 min active rest phase (60_ 70 % HRmax), in addition to the phases of 5 min warming up and 3 min cooling down. 2 months for 33 minutes/session. The 4×4 HIIT protocol will require a working phase lasting 4 minutes (85 – 95% HRmax), repeated 4 times and separated by a 3 min active rest phase (60_ 70 % HRmax), in addition to the phases of 5 min warming up and 3 min cooling down. 20
Experimental Group Low volume high intensity interval training for 16 minutes/session. The 2×4 HIIT protocol will require a working phase lasting 2 minutes (85 – 95% HRmax), repeated 4 times and separated by a 1 min active rest phase (60_ 70 HRmax), in addition to the phases of 3 min warming up and 2 min cooling down. 2 months for 16 minutes/session. The 2×4 HIIT protocol will require a working phase lasting 2 minutes (85 – 95% HRmax), repeated 4 times and separated by a 1 min active rest phase (60_ 70 HRmax), in addition to the phases of 3 min warming up and 2 min cooling down. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All the patients will be 1. Obese women. 2. A self-reported sedentary lifestyle. 3. Age between 35 to 45 years old. 4. BMI will be 30 to 39.9 kg/m2 and waist circumference of ≥88 cm. 5. Dyslipidemia: • Total blood cholesterol levels more than 200 mg/dl • LDL blood cholesterol levels more than 130 mg/dl • HDL blood cholesterol levels less than 50 mg/dl • Triglyceride levels more than 150 mg/dl Patients who will meet one of the following criteria will be excluded from the study: 1. Males 2. Subjects with cardiovascular disorders or diabetes mellitus etc. 3. Musculoskeletal or neurological limitations to physical exercise. 4. Pregnancy 5. Morbidly obese BMI ≥ 40 kg/m2 or BMI < 30 kg/m2 Adult: 19 Year-44 Year 35 Year(s) 44 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 22/04/2020 Ethical Committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432 Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Dual-energy X-ray absorptiometry Pre-test and Post-test
Secondary Outcome Laboratory Investigations: the chemical analysis of blood lipid profile (dyslipidemia) e.g. triglycerides, cholesterol and phospholipids. Pre-test and Post-test
Secondary Outcome Self-paced cycle exercise protocol: to measure peak heart rate. Pre-test and Post-test
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outclinic of Faculty of Physical Therapy Cairo University El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432 Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mark Mouneir Seddik 9 heussei Waly street Meniet El Sereg El Sahel Shoubra Cairo 11672 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mark Mouneir Seddik 9 Heussein Waly Meniet eh sereg el sahel shoubra Cairo 11672 Egypt Individual
Secondary Sponsor Ami N Wadee 51 Ebn Fadle El Omery Toson Street Shoubra Cairo 11672 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mark Mouneir Seddik 9 Heussein Waly Meniet El Sereg El Sahel Shoubra Cairo 11672 Egypt
Awny Foad Rahmy El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432 Giza 12613 Egypt
Amir N Wadee 51 Ebn Fadle El Omery Toson Shoubra Cairo 11672 Egypt
Ahmed Mahdy Ahmed El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432 Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Moneir Seddek alseddikcenter@gmail.com 01228308205 9 Heussein Waly street Meniet El Sereg El Sahel
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Physiotherapist in Ministry of Health and Population El Warrak Administration
Role Name Email Phone Street address
Public Enquiries Awny Foad Rahmy Info@pt.cu.edu.eg 01001794314 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor in Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Amir N Wadee anazih@cu.edu.eg 01222367919 51 Ebn Fadle El Omery Toson Shoubra
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant professor in Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mahdy Ahmed Info@pt.cu.edu.eg 01007056624 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432
City Postal code Country Position/Affiliation
Giza 12613 Egypt Lecturer in Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all data will be shared Informed Consent Form,Statistical Analysis Plan 12 months International publication
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