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.: PACTR202111640499636 Date of Approval: 10/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title home based pulmonary exercise for rehabilitation in post covid patients
Official scientific title effect of home based pulmonary rehabilitation on exercise capacity in post covid patients. a randomized control trail
Brief summary describing the background and objectives of the trial Coronavirus disease 2019 (COVID-19) is a pandemic includes different presentations have been reported as abdominal pain, lack of appetite, vomiting, diarrhea, altered taste sensation and ageusia, bilateral pneumonia, pleural effusion, radiological lung consolidation, altered liver function, lymphadenopathy, acute kidney injury, neurological manifestations and vascular (venous and arterial) thrombosis. So covid 19 can result in a large variety of chronic health issues such as impaired lung function, reduced exercise performance and diminished quality of life. Our study aimed to investigate influence of pulmonary rehabilitation in post COVID-19 patients through home program exercises
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 22/08/2021
Actual trial start date 07/10/2021
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pulmonary rehabilitation exercises 3 months Regular walking 30-60 min, 5 days/week for 3 months Respiratory muscle training performed (diaphragmatic strengthening) 10-15 min, twice per day, daily for 3 months Resisted training 3 sets of 10 repetitions, twice /day, 5-7 days/ week using low weight 1 kg for both quadriceps and selected upper limb muscle group for 3 months 40
Control Group control 3 months we just follow up patient and make measurements pre and post 3 months without doing any pulmonary rehabilitation exercises 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
post covid patients Higher-risk patients were generally excluded, such as patients with HF and New York Heart Association functional class III to IV symptoms, a reduced ejection fraction (<40%), meaningful dysrhythmia, Canadian Cardiovascular Class 3 or higher angina pectoris, older age (eg, >75 years), a significant physical limitation, or a markedly reduced peak functional capacity (eg, <2 metabolic equivalent tasks). presence of complex ventricular dysrhythmias during exercise testing or recovery, presence of angina or other significant symptoms (unusual shortness of breath, light- headedness, or dizziness occurring only at high levels of exertion<METs , complicated MI, or revascularization procedure, presence of congestive heart failure, presence of signs or symptoms of post event/post procedure ischemia, Presence of clinical depression Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 75 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 07/09/2021 research ethical committee faculty of Medicine Beni Suef University
Ethics Committee Address
Street address City Postal code Country
Beni Suef west nile Beni-Suef 1111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome SF-36 questionnaire T1
Primary Outcome fatigue index T1
Primary Outcome 6 min walk test T1
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of chest diseases department faculty of medicine Beni- Suef University Beni Suef Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nesma Ahmed Helmy new obour cairo 11123 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor dr. Ahmed Abd El Moneim Ab Del Hakim cairo cairo 1111 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nesma Helmy nesmaahmed101@gmail.com 01287902936 cairo
City Postal code Country Position/Affiliation
cairo 11322 Egypt lecturer basic science faculty of physical therapy beni suef university delta university for science and technology
Role Name Email Phone Street address
Scientific Enquiries tamer Abo Elyazed Tamer.i.aboelyazed@gmail.com 000000000 cairo
City Postal code Country Position/Affiliation
cairo 112121 Egypt ass.prof lecturer internal medicine faculty of physical therapy beni suef university
Role Name Email Phone Street address
Public Enquiries laila Alsharawy lailaanwer2015@gmail.com 000000000 beni suef
City Postal code Country Position/Affiliation
beni suef 11111 Egypt Lecturer of Chest Diseases faculty of medicine beni suef university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification are available and shared after finishing study Informed Consent Form,Statistical Analysis Plan,Study Protocol this should be done within 12 months or more of study date open access type of analyses to achieve aims in the approved proposal Proposal should be directed to dr.nesmaahmed@pt.bsu.edu.eg. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website
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