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.: PACTR202303820671945 Date of Approval: 31/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Return to running postpartum: A RCT to determine the effectiveness of the available evidence.
Official scientific title Return to running postpartum: A RCT to determine the effectiveness of the available evidence.
Brief summary describing the background and objectives of the trial After giving birth many women are met with the challenge of when to return to running. Dealing with the postpartum body can be a challenge for the individual and health care professional. In a previous objective the literature was scoped for evidence on how women should return to running. The aim of this RCT is to determine the effectiveness of the guidelines/protocols found in literature when compared to the general practices that most women adhere to when navigating their way back to running after giving birth. The effectiveness will be assessed by running performance (time and distance run), presence of PFD and muscle testing (strength, neuromuscular control and endurance) at three months and six months postpartum between the two groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/05/2023
Actual trial start date
Anticipated date of last follow up 01/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 74
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 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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Guidelines group Follow-up tests will be done at 3 and 6 months postpartum 6 months postpartum Participants will be given certain guidelines to follow, following the birth of a child. These guidelines will guide them through their return to running journey and have specific exercises or criteria that they have to follow to ensure that they are ready to return to running. 37
Control Group General practice group Follow-up visits at 3 and 6 months postpartum 6 month postpartum Participants in this group will follow the general practice of women that return to running postpartum. They will have some broad guidelines to follow which was determined by a previous objective. An online survey was completed by women who have already returned to running postpartum and their responses were summarised into the general practice that this group will follow. 37 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• The participant must be between the ages of 18-45 years old. To enable the participant to give consent for the study and to avoid the effects of older, complicated pregnancies • The participant must have given birth to a child/children. • The participant must have been active for a minimum of 150min a week with running as least 30min, once a week before or during pregnancy • The participant must be able to understand English • Participants with a diagnosed neuro-musculoskeletal disease • Participants experiencing post-birth complications • Participants that have current injuries Adult: 19 Year-44 Year 18 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 05/10/2022 Human Research Ethics Committee of Witwatersrand University
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Avenue, Braamfontein Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare women returning to running following the available evidence, to women returning to running following the general practice. Completion of the trial
Secondary Outcome • Determine the effectiveness of available evidence for the return to running postpartum, by assessing running performance (time and distance run), presence of PFD and muscle testing (strength, neuromuscular control and endurance) 3 and 6 month follow-up
Secondary Outcome • Determine the effectiveness of the general practice followed when returning to running postpartum by assessing running performance (time and distance run), presence of Pelvic Floor Dysfunction and muscle testing (strength, neuromuscular control and endurance) 3 and 6 month follow-up
Secondary Outcome • Compare the effectiveness of the current evidence to the general practice by assessing running performance (time and distance run), presence of Pelvic Floor Dysfunction and muscle testing (strength, neuromuscular control and endurance) at 3 and 6 months postpartum. 3 and 6 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Birth of love antenatal classes 13, 2nd Ave, Walmer Port Elizabeth 6070 South Africa
Helen Ward Mother and Well baby clinic 40 Park Drive, St Georges Port Elizabeth 6001 South Africa
Dr Andrews Suite 401 St Georges Medical Centre, 40 Park Drive Port Elizabeth 6001 South Africa
Dr T Victor 40 Park Drive, Life St. Georges Hospital Port Elizabeth 6001 South Africa
Dr Des Antenatal Classes 10 Sandler Road, Fairmount Johannesburg 2192 South Africa
Bedfordview mother and baby centre 15 Nicol Road, Bedfordview Johannesburg 2192 South Africa
Dr Paterson Netcare Parklane, Parktown Johannesburg 2192 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SASP Unit 4 Parade on Kloof Office Park Bedforview Johannesburg 2000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rochelle 84 Park Drive Port Elizabeth 6001 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rochelle Bouwer rtmoles@gmail.com +27760919102 84 Park Drive
City Postal code Country Position/Affiliation
Port Elizabeth 6001 South Africa PhD Student
Role Name Email Phone Street address
Public Enquiries Rochelle Bouwer rtmoles@gmail.com +27760919102 84 Park Drive
City Postal code Country Position/Affiliation
Port Elizabeth 6001 South Africa PhD Student
Role Name Email Phone Street address
Scientific Enquiries Corlia Brandt corlia.brandt@wits.ac.za +27117172014 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa PhD Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The trial data will be collected on the RedCap platform. All the individuals participant data collected during the trial on the redcap platform will be made available after de-indentification. Clinical Study Report,Informed Consent Form,Study Protocol The above documents as well as the results will be available immediately after publication with no end date. Access will be open to all whom are interested. If more information is wanted, other than the above documents that will be available on this platform, the request can be emailed to the researcher. A decision will be made by the researcher together with her supervisor, if the request is reasonable and legitimate. If access is granted to more information, the documents requested will be emailed to the recipient.
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