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.: PACTR202311572866804 Date of Approval: 23/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of an exercise intervention on fitness, perceptual-cognitive functioning and selected biomarkers of depression in persons with Major Depression
Official scientific title Effect of an exercise intervention on fitness, perceptual-cognitive functioning and selected biomarkers of depression in persons with Major Depression
Brief summary describing the background and objectives of the trial The prevalence of stress-related disorders such as depression, post-traumatic stress disorder and anxiety disorders is a growing factor and global health concern (Casper, 2005:212). Craft (2005:168) examined that exercise at a moderate intensity decreases depression among chronically depressed female participants, with the use of antidepressant medication (Craft, 2005:18). According to Harris et al. (2006:84), in a ten-year longitudinal study of adults aged 18 years and older, diagnosed with Major Depression, the effect of physical activity on global depression was -2.24 (SE = .64, p< .001), which illustrates that higher physical activity levels were linked with lower levels of global depression (Harris et al., 2006:82). This implies that, at any phase, one increment of physical activity was coupled with a 2.24-point decrease in depression (Harris et al., 2006:82). The mechanisms responsible for the antidepressant effect of exercise on MD are not well established (Ströhle, 2009:781). The link may be between neurobiological and psychological mechanisms responsible for the beneficial effects (Ströhle, 2009:781). Therefore, this trial aims to determine the effect of a supervised exercise intervention on fitness, perceptual-cognitive functioning measured with multi-object tracking, selected biomarkers of depression and depressive level in young adults aged 18 - 25 years presenting with symptoms of Major Depression. The objective of this trial is to firstly determine the relationship between objectively determined physical activity, fitness, perceptual-cognitive functioning and depressive state and selected biomarkers of depression of individuals with Major Depression, and secondly to determine the effect of an exercise intervention on physical activity, fitness, perceptual-cognitive functioning and depressive state and selected biomarkers of depression of individuals with Major Depression.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/01/2024
Actual trial start date
Anticipated date of last follow up 13/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aerobic exercise intervention Three days days per week progressing from 40 - 60 minutes 12-weeks An aerobic intervention will be followed for a period of 12 weeks. Participants will be expected to attend three training sessions per week. The intervention will consist of an outdoors circuit exercise program consisting of aerobic exercises (walking, jogging, and variety of jumps) combined with bodyweight exercises (push-ups, sit-ups, lunges and squats). The intensity of the exercise program will range between 70% - 80% of VO2 max. The duration of the whole exercise session will be 40 minutes in the first month, 10 minutes warm-up; 20 minutes circuit training and 10 minutes of cool down and stretching. Progression will be attained by increasing the aerobic time with 5 minutes every month (4 weeks). All participants will have access to a therapist and will receive therapy based on the National Institute for Health and Care Excellence (NICE) guidelines and best practices for the treatment of depression. 50
Control Group Stretching to mask exercise Two days per week for 40 minutes 12-weeks The control group will receive two sessions of stretching exercises that will consist of performing 10 stretches each lasting 30 – 40 seconds and performing three sets of each. All the major muscle groups and joints will be included. The training sessions of the control group will also be 40 minutes in duration. The control group will not perform any aerobic or resistance training. All participants will have access to a therapist and will receive therapy based on the National Institute for Health and Care Excellence (NICE) guidelines and best practice for the treatment of depression. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Persons diagnosed with a mild to moderate Major Depression according to the BDI-scale (score between 10 – 29); • Diagnosed with depression for the first time; • Between the ages of 18-25 years; • Not using antidepressant medication; and • Not engaging in psychotherapy sessions at a preferred practitioner. • use antidepressant medication; • absolute contraindications for exercise participation according to ACSM guidelines; • participants with orthopaedic limitations; • pregnant or lactating women; • participants who diagnosed with post-natal depression; • participants with bipolar depression; and • participants diagnosed with severe Major Depression. Adult: 19 Year-44 Year 18 Year(s) 25 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 26/10/2020 Health Resaerch ethics committee for Humans
Ethics Committee Address
Street address City Postal code Country
11 Hoffmans Street Potchefstroom 2531 South Africa
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 21/11/2023 HREC
Ethics Committee Address
Street address City Postal code Country
11 Hoffman Sstreet Potchefstgroom 2531 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Beck Depressive Index score Baseline and end
Primary Outcome Perceptual-cognitive function with Multi-object tracking Baseline and end
Primary Outcome Cardiorespiratory fitness Baseline and end
Primary Outcome Cortisol concentrations baseline and end
Primary Outcome Habitual physical activity Baseline and end
Secondary Outcome Body composition Baseline and end
Secondary Outcome Screen time Baseline and end
Secondary Outcome Association between Beck Depression Index and cortisol concentrations Baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
PhASRec North West University 11 Hoffman Street Potchefstroom 2531 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NWU Internal funding 11 Hoffman Street Potchefstroom 2531 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor North West University 11 Hoffman Street Potchefstroom 2531 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Ankebe Kruger 11 Hoffman Street Potchefstroom 2531 South Africa
Prof Stanislaw Czyz University of Wroclaw, Wroclaw Poland
Dr Stephan Steyn 11 Hoffman Street Potchefstroom 2531 South Africa
Mrs Lizaan Enslin 11 Hoffmand Street Potchefstroom 2531 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanlie Moss Hanlie.moss@nwu.ac.za +27182991821 11 Hoffman Street
City Postal code Country Position/Affiliation
Potchefstroom 2531 South Africa Research Professor at North West University
Role Name Email Phone Street address
Public Enquiries Wayne Towers Wayne.towers@nwu.ac.za +27182992092 11 Hoffman Street
City Postal code Country Position/Affiliation
Potchefstroom 2531 South Africa Head of Ethics Health sciences
Role Name Email Phone Street address
Scientific Enquiries Hanlie Moss Hanlie.moss@nwu.ac.za +27182991821 11 Hoffman Street
City Postal code Country Position/Affiliation
Potchefstroom 2531 South Africa Principle investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Study Protocol Data will be available after publication of the articles for two years Access to the data will be controlled by the principle investigator and requests will be handled by the principle investigator through an email to Hanlie.moss@nwu.ac.za. Requests from researchers conducting systematic reviews will be considered.
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