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.: PACTR202305590076796 Date of Approval: 02/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Respiratory Muscle Training for Athletes post COVID-19: A Pilot Study for a Randomised Controlled Trial to determine Efficacy in Improving Cardiorespiratory Fitness
Official scientific title Respiratory Muscle Training for Athletes post COVID-19: A Pilot Study for a Randomised Controlled Trial to determine Efficacy in Improving Cardiorespiratory Fitness
Brief summary describing the background and objectives of the trial Prior to the COVID-19 pandemic acute respiratory tract infections are the most common cause of non-injury related illness and time away from sport. Long-term cardiorespiratory sequelae may be associated with fatigue and poor exercise tolerance, causing concern among athletes. Endurance training requires the ability to resist fatigue, therefore performance may be affected by cardiopulmonary limitations. Respiratory muscle training improves immune response, mobilises secretions, decreases blood pressure, pulmonary artery pressure and blood glucose in healthy individuals. No studies investigating inspiratory muscle training to aid recovery from COVID-19 exist. The objective of this trail is to determine the efficacy of respiratory muscle training on athletic performance in athletes who are recovering from COVID-19.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/11/2022
Actual trial start date 21/11/2022
Anticipated date of last follow up 30/04/2023
Actual Last follow-up date 30/03/2023
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 13
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal endurance training The participant will continue their normal endurance training (running/cycling) for 6 weeks. Six weeks. The control group will be required to attend a VO2max, MIP, breathing pattern and RPE assessments with the primary researcher. They will continue their normal training and log it in a training diary. After six weeks they will attend another assessment, testing the same parameters. 7 Dose Comparison
Experimental Group Respiratory Muscle Training The participant will be given their own Phillips Respironics Threshold IMT device, which provides a consistent specific pressure set to 50% of their Mean Inspiratory Pressure. Every ten days the participant will increase the pressure on the IMT devices to 60%, then 70%, and finally 80%MIP during the 6-week study period. The participant will then need to continue the RMT of 30 breaths once a day, 5 days a week. If they are unable to manage 30 breaths at the increased pressure, they will remain on the lower setting. Six weeks The participants will be required to undergo a VO2max test, MIP test, and breathing pattern and RPE assessments. The intervention group will attend an individual consultation with the primary researcher and will be shown a video of the correct manner to perform the RMT including exhaling completely before the next inspiratory breath to avoid an increase in intrathoracic pressure. The participant will be given their own Phillips Respironics Threshold IMT device, which provides a consistent specific pressure set to 50% of their MIP. A nose peg is used to prevent initiation of the sniff reflex while practicing with the primary researcher observing to ensure proper technique. The athletes are encouraged to continue and log their normal training in addition to the RMT. After six weeks, the participants will be required to repeat the VO2max, MIP, breathing pattern and RPE assessments. 6
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
COVID-19 convalescent endurance athletes including runners and cyclists. Male and female over the age of 18. Participants must reside in Johannesburg, South Africa Athletes who did cardiovascular exercise for three or more hours per week prior to contracting COVID-19 will be eligible. Athletes must comply with the published return to sport criteria i.e., 10 days rest after diagnosis and 7 symptom-free days, and the ability to carry out activities of daily living and walk 500m effortlessly (Elliott et al., 2020). Participants need to be able to run for 30 minutes at a comfortable pace. Those with co-morbidities or severe disease need to have consulted a sports physician prior to resumption of sport. Athletes currently in quarantine or isolating due to a positive COVID-19 test result will be not be eligible to participate. Athletes experiencing a new onset of COVID-19 symptoms or a positive exposure within 10 days of commencing the study. Athletes who are already using RMT as part of their training programme post-COVID-19 will be excluded. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 59 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 25/10/2021 Human Research Ethics Commitee Medical
Ethics Committee Address
Street address City Postal code Country
3rd floor, Room 306, Phillips Tobias Building, Cnr York Road and 29 Princess of Wales Terrace, Faculty of Health Sciences, Parktown, Johannesurg Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Compare the difference in VO2max (mean and SD) from baseline to follow up between intervention and control groups. 6 weeks
Primary Outcome Compare the difference in MIP (mean and SD) from baseline to follow up between intervention and control groups. Six weeks
Secondary Outcome A between group comparison of RPE at baseline and follow up Six weeks
Secondary Outcome COVID-19 symptoms, if any, they continue to experience. Six weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of the Witwatersrand Jubilee Street Johannesburg 2000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty Research Fund Faculty of Health Sciences, York Road, Parktown Johannesburg 2000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Physiotherapy Department Faculty of Health Sciences, York Road, Parktown Johannesburg 2000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cheryl Haley cheryl@ourphysio.co.za +27823355649 Physiotherapy Department, Faculty of Health Sciences, York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2000 South Africa PhD student
Role Name Email Phone Street address
Public Enquiries Helena van Aswegen helena.vanaswegen@wits.ac.za +27117173706 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2000 South Africa Personal Professor
Role Name Email Phone Street address
Scientific Enquiries Benita Olivier benita.olivier@wits.ac.za +27117173701 Therapeutic Sciences, 7 York Street, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2000 South Africa Professor Department of Physiotherapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be made available for sharing after acceptance for publication which will be within 12 months after the end of the data collection period. Permission to access this de-identified data has been requested from the participants. They have been informed that data will not be sold for profit and that they can indicate in the consent form if they prefer for the data to be used within a specific time frame, and not to be used in commercial projects. A project description with its de-identified meta-data will be shared by the primary researcher on the Wits WiSH website as well as on shelves on the Wits Wired Space platform. Data can be located through the use of a search function. From here, interested researchers will follow a REDCap link where more information (project metadata) can be found. The process for requesting access to data will also be described on the Wits Sport and Health (WiSH) website and the Data Management and Sharing Guide will be available via a download function on this same website.The DOI of the dataset (if available at the time of publication) on which the publication findings are based will feature in the associated publication. The data access committee, research group director and principal investigator who collected the data will review the request and inform the Recipient of the outcome via email. If the request is denied, reasons will be provided, and the Recipient can appeal through the University’s Data Access Committee. The Recipient will sign a Conditions of Use Agreement. Once the Recipient has obtained ethical clearance and the access agreement have been signed, the data will be released to the Recipient. The research group director will keep a record of who the data is shared with as well as the intended use of the data. All Recipients, Recipient Institutions and Data Users will be bound by the Conditions of Use Agreement which can be found in the Wits Sport and Health Research Group Data Management and Sharing Guide. Informed Consent Form Sharing Time Frame is limited by the participant's request. Identifying information, such as name, surname, and contact details, will be removed from the data and a study number will be allocated. The link between the study number and the identifying information will be kept in an access-controlled database which is only accessible by the data manager, access control committee and research group director. To review the accuracy of your data, feel free to contact the data manager (via Benita Olivier, benita.olivier@wits.ac.za).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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