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.: PACTR202311561948428 Date of Approval: 29/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of traditional versus virtual Reality-simulated treadmill aerobic exercises on fatigue and cognitive function in post-COVID-19 subjects
Official scientific title Effect of traditional versus virtual Reality-simulated treadmill aerobic exercises on fatigue and cognitive function in post-COVID-19 subjects
Brief summary describing the background and objectives of the trial Since its debut in late 2019, coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has fast become a major international epidemic. There are continual signs and symptoms that appear for the duration of or after COVID-19 infection, comprising dyspnea, cognitive impairment, anxiety, and sleep disturbances. Exercise is an essential part of pulmonary rehab applications for post-COVID patients. Virtual Reality (VR) is a rising era used for the remedy of many scientific conditions. This study aims to compare the effect of virtual reality-simulated aerobic exercise to the effect of traditional aerobic exercise with respect to cognitive function, fatigue, sleep quality, and participant satisfaction with exercise in post-COVID-19 individuals.
Type of trial RCT
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 01/12/2021
Actual trial start date 01/12/2021
Anticipated date of last follow up 30/03/2022
Actual Last follow-up date 30/03/2022
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional exercise group Three days a week for 4 weeks 30-45 minutes Moderate-intensity continuous aerobic training on a treadmill was designed. The intensity was determined based on the Karvonen formula, as follows: THR=[HRrest + (HRmax – HRrest) 50 -60%]. 10 Active-Treatment of Control Group
Experimental Group virtual reality simulated exercise group Three days a week for 4 weeks. 30-45 minutes Moderate-intensity continuous aerobic training on a treadmill, augmented by non-immersive virtual reality, was designed. The intensity was determined based on the Karvonen formula, as follows: THR=[HRrest + (HRmax – HRrest) 50 -60%]. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- past history of COVID-19 infection within 3-4 months - age from 30-60 years -Women and men -persistent dyspnea and fatigue -mild cognitive impairment -oxygen saturation ≥ 94 % - past history of severe COVID-19 infection -previous ICU admission. -coexisting respiratory disease -cardiovascular disease -renal failure -smokers - musculoskeletal problems -neurological limitations to exercise -contraindications to maximal exercise testing. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 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 07/11/2021 Ethics Committee of Scientific Research at Faculty of Physical Therapy
Ethics Committee Address
Street address City Postal code Country
7 Ahmad El Zayat street, Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Chalder Fatigue Scale before and after 4 weeks
Primary Outcome Montreal Cognitive Assessment (MoCA) Before and after 4 weeks
Secondary Outcome Pittsburgh Sleep Quality Index (PSQI) Before and after 4 weeks
Secondary Outcome Participant satisfaction with exercise After 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Mahalla Chest Hospital EGYPT, El-Mahalla el-Kubra, Egypt, 66655 El Mahalla Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Fund Ahmad El Zayat street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo University Al Gamaa street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sara Ali Awad Allah Al Mahalla Al Mahalla El Kobra Egypt
Dalia Ezzat El Sharawy Al Mahalla Al Mahall El Kobra Egypt
Gehad Ali Abd Elhaseeb 6 October Giza Egypt
Mona Ahmed Abdelwahab Al Haram Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad Mahdi Ahmad ahmed.mahdy@pt.cu.edu.eg 2001007056624 Abdeen
City Postal code Country Position/Affiliation
Cairo Egypt Department of Physical Therapy for Cardiovascular and Respiratory Disorders Faculty of Physical Therapy at Cairo University
Role Name Email Phone Street address
Public Enquiries Sara Ali Awad Allah saraali123321123@gmail.com 2001061174150 Almahalla
City Postal code Country Position/Affiliation
Al Mahalla Egypt Department of Physical Therapy for Cardiovascular and Respiratory Disorders Faculty of Physical Therapy at Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ahmad Mahdi Ahmad ahmed.mahdy@pt.cu.edu.eg 2001007056624 Abdeen
City Postal code Country Position/Affiliation
Cairo Egypt Department of Physical Therapy for Cardiovascular and Respiratory Disorders Faculty of Physical Therapy at Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results reported in this study can be shared after deidentification (Text, Tables, Figures and appendices). Study Protocol Starts after publication and for 1 year Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 22/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/11/2023 Result - 28/11/2023 Result - 28/11/2023 Result - 28/11/2023 Result - 28/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information