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.: PACTR201707002369196 Date of Approval: 20/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Studies of Continuous and Interval Exercise Training on Metabolic and Cardiovascular Health Indicators in Obese and Overweight Females
Official scientific title Studies of Continuous and Interval Exercise Training on Metabolic and Cardiovascular Health Indicators in Obese and Overweight Females
Brief summary describing the background and objectives of the trial Obesity is associated with some non ¿ communicable diseases. The major diseases associated with obesity include hypertension, diabetes mellitus, and atherosclerosis, as well as certain types of cancer; there are also many additional less known complications of the disease (Bray, 1985). Overweight and obesity now ranks as the fifth highest global risk factor for mortality and is the cause of an estimated 35.8 million (2.3%) of global DALYs (disability-adjusted life years) lost (WHO, 2010). In a systematic review on the prevalence of overweight and obesity of adult Nigerians, Chukwuonye et al. (2013) reported that the prevalence of overweight and obese individuals in Nigeria is of epidemic proportions. There is therefore, a need to pay closer attention to combating these health disorders. People generally become obese when, over a period of time, their energy intake exceeds their energy expenditure (National Institute for Health & Clinical Excellence (NICE), 2006). There is epidemiological evidence that an inverse relationship exists between physical activity and body weight, and that body fat is more favourably distributed in individuals who are physically active (Anderson et al., 1991; Wing et al., 1991 and Di Pietro, 1995). Studies have shown that both continuous endurance exercise as well as high-intensity interval exercise increase fat oxidation post-training, but it is unclear which training protocol elicits the greater adaptation in overweight and obese females (Manning, 2011).Therefore, this study is designed to assess the efficacy of two different training modes of exercise in reversing the anthropometric, cardiovascular and metabolic features of overweight and obesity in females. This study will contribute to the recent recommendations to explore further the effective mechanism of exercise training in weight management. The result from this study will also contribute to the already existing guidelines for exercise prescription in weight management.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Genetic Diseases,Nutritional, Metabolic, Endocrine,Obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 11/01/2016
Actual trial start date 07/03/2016
Anticipated date of last follow up 14/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 97
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation using coin-tossing procedure Allocation was determined by the holder of the sequence who is situated off site. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Interval Exercise Group Three time a week Ten weeks It involves 30 seconds of high intensity exercise followed by 90 seconds low intensity exercise in the ratio 1: 1.5. The exercise intensity at 70% of HR max for a period of 20 minutes. In the 3rd and 4th week the intensity of the exercise is increased to 75% of the HR max for duration of 25 minutes while the low intensity is at 60% HR max. Subsequently the exercise regimen is graduated. 35
Experimental Group Continuous Exercise Group Three time a week Ten weeks It starts with 2 weeks of exercise intensity at 70% of HR max for a period of 20 minutes. In the 3rd and 4th week the intensity of the exercise is increased to 75% of the HR max for duration of 25 minutes. The exercise regimen is graduated every two weeks by 5% increase in the HR and the duration by 5 minutes. 35
Control Group Control Group Three time a week Ten weeks This group of participants will continue with their normal activities of daily living and will not be involved in any form of structured exercise. 35 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. A regular (28 ¿ 35 day) menstrual cycle, 2. No pregnancy or lactation, 3. A Body Mass Index (BMI) > 25 kg.m2, defined as a BMI of 25 ¿ 29.9 kg.m2 (overweight) and ¿30 kg.m2 (obese). 4. Participants who must not have gained or lost more than 3 kg of weight within the previous three months 5. Participants who have not changed their diet dramatically with respect to caloric intake within the previous three months. 6. Participants that are sedentary and had not participated in a regular exercise program, defined as at least 2 hours of regular strenuous activity per week for the previous year, prior to testing. 1 Participants that were high-level athletes or splinters 2 Participants with any kind of orthopaedic disorder limiting the walking / running practice 3 Participants with Cardiovascular or cardiorespiratory disorder during exercise 4 Participants with too large variation of physical activity frequency 5 Participants with a current acute illness or unstable chronic illness or recent injury 6 Participants using beta blocking medications 18 Year(s) 55 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 17/11/2015 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital, Ituku Ozalla Ituku-Ozalla, Enugu 12345 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiovascular Parameters-Systolic Blood Pressure, DIastolic Blood Pressure, Resting Heart Rate, Rate Pressure Product, Pulse Pressure, Mean Arterial Pressure Pre-exercise training Fifth week post exercise training Tenth week post exercise training
Primary Outcome Cholesterol Profile-Low Density Lipoprotein, High Density Lipoprotein, Very Low Density Lipoprotein, Triglyceride, Total Cholesterol Pre-exercise training Fifth week post exercise training Tenth week post exercise training
Primary Outcome Anthropometric Parameters and Body Composition-Height, weight, Age, Body Mass Index, waist circumference, hip circumference, waist hip ration, body fat, body water, body muscle, bone mass Pre-exercise training Fifth week post exercise training Tenth week post exercise training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Enugu Campus Department of Medical Rehabilitation Enugu 12345 Nigeria
University of Nigeria Teaching Hospital Ituku-Ozalla Enugu 12345 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Rita Ativie 13 Chief Pat Onumadu street, Iji-Nike, Abakpa 12345 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dennis Ativie 13 Chief Pat Onumadu street, Iji-Nike, Abakpa 12345 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof. John C. Igweh Department of Human Physiology, Delta State University. Abraka, Delta State 23456 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rita Ativie rittydon@yahoo.com 08039470226 13 Chief Pat Onumadu street,
City Postal code Country Position/Affiliation
Enugu 12345 Nigeria Lecturer II
Role Name Email Phone Street address
Public Enquiries Rufus Adedoyin radedoyi@yahoo.com +234 803 382 9978 Department of Medical Rehabilitation, Obafemi Awolowo University.
City Postal code Country Position/Affiliation
Ile-Ife, Osun State. 21221 Nigeria
Role Name Email Phone Street address
Scientific Enquiries John C. Igweh jcigweh@gmail.com +234-803-444-4459 Department of Human Physiology, Delta State University
City Postal code Country Position/Affiliation
Abraka, Delta State 222222 Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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