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.: PACTR201802003021680 Date of Approval: 27/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Exercise and Insulin Resistance
Official scientific title Superior Effects of Short-Term High versus Moderate Intensity Training on Insulin Resistance in Overweight and Obese Adults: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Exercise effects on insulin resistance are dependent on the intensity and duration of the intervention. In chronic training studies, improvements in insulin resistance are amplified by decreases in body fat and/or increases of cardiorespiratory fitness. The purpose of this study was to determine the effects of short-term high intensity interval training (HIIT) and continuous moderate intensity training (CMIT) on insulin resistance (HOMA-IR) in physically inactive overweight/obese adults.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Insulin Resistance,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/06/2016
Actual trial start date 01/08/2016
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date 02/10/2017
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 95
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 A pseudo-random number generator software (Research Randomizer version 4.0) Allocation was assigned based on computer generated numbers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group High Intensity Interval Training (HIIT) 18-24 minutes per day 10 consecutive days Participants performed a total of 18-24 minutes (including warm up and cool down for 3 minutes) cycling on an electronically-braked cycle ergometer (Lode Excalibur Sport, Groningen, The Netherlands) for 10 consecutive days, with at least 24 hours in-between sessions. Participants were required to maintain a workload that corresponded with a wattage that solicited 90-100% of pre-determined peak aer 31
Experimental Group Continuous Moderate Intensity Training (CMIT) 18-24 minutes per day 10 consecutive days Participants performed a total of 18-24 minutes (including warm up and cool down for 3 minutes) cycling on an electronically-braked cycle ergometer (Lode Excalibur Sport, Groningen, The Netherlands) for 10 consecutive days, with at least 24 hours in-between sessions. Participants were required to maintain a workload that corresponded with a wattage that solicited 60-70% of pre-determined peak aero 33
Control Group Control (CNT) 10 consecutive days The CNT underwent pre and post intervention assessments without taking part in the exercise intervention. 31 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Physically inactive (less than 30 minutes of physical activity five days a week) Overweight/obese (BMI ¿ 25 kg/m2) Smokers (current or chronic) Taking medications that are known to affect body composition and metabolism 18 Year(s) 35 Year(s) Both
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 28/06/2016 Biological Research Ethics Committee (BREC)
Ethics Committee Address
Street address City Postal code Country
University Road Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Insulin resistance (HOMA-IR) Pre-intervention Post-intervention
Primary Outcome Insulin sensitivity (HOMA-IR) Pre-intervention Post intervention
Primary Outcome Beta cell function (HOMA-beta) Pre-intervention Post intervention
Secondary Outcome Body weight (BW) Pre-intervention Post intervention
Secondary Outcome Body fat (BF) Pre-intervention Post intervention
Secondary Outcome Peak aerobic power (VO2peak) Pre-intervention Post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Human Performance Laboratory (HPL), University of KwaZulu-Natal University Road Durban 4000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of KwaZulu-Natal College of Health Sciences University Road Durban 4000 South Africa
National Research Foundation (NRF) Meiring Naudé Road Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of KwaZulu-Natal College of Health Sciences University Road Durban 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Tshidi Thaane University Road Durban 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tshidi Thaane t.thaane@gmail.com 0788871384 Biokinetics Clinic, Department of Sport Science (Q Block). University of KwaZulu-Natal, Westville Campus. University Road.
City Postal code Country Position/Affiliation
Durban 4000 South Africa Student
Role Name Email Phone Street address
Public Enquiries Phindile Nene Nenep1@ukzn.ac.za +27 312608280 University Road
City Postal code Country Position/Affiliation
Durban 4000 South Africa Postgraduate Officer: Health Sciences
Role Name Email Phone Street address
Scientific Enquiries Tshidi Thaane t.thaane@gmail.com 0788871384 Biokinetics Clinic, Department of Sport Science (Q Block). University of KwaZulu-Natal, Westville Campus. University Road.
City Postal code Country Position/Affiliation
Durban 4000 South Africa Student
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information