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.: PACTR202302877569441 Date of Approval: 07/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF DIAPHRAGMATIC RELEASE TECHNIQUE VERSUS BREATHING EXERCISES AND PRONE POSITIONING ON PHYSICAL PERFORMANCE IN COVID-19 WOMEN
Official scientific title EFFECT OF DIAPHRAGMATIC RELEASE TECHNIQUE VERSUS BREATHING EXERCISES AND PRONE POSITIONING ON PHYSICAL PERFORMANCE IN COVID-19 WOMEN
Brief summary describing the background and objectives of the trial The main concern in COVID-19 is the involvement of the lungs and respiratory system which may result in dyspnea, low blood oxygen saturation, and thereby, reducing physical performance. Although manual myofascial release does not fight viruses, the literature supports its use in patients with respiratory tract infections. This study is designed to mainly assess the effect of diaphragmatic release on physical performance compared to routine breathing exercises and prone positioning in COVID-19 women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Rehabilitation
Anticipated trial start date 01/07/2022
Actual trial start date
Anticipated date of last follow up 22/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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
Experimental Group Diaphragm release 5-10 deep breaths/set Three sessions/week Three weeks The therapist makes manual contact with the pisiform, hypothenar region and the last three fingers to the underside of the seventh to tenth rib costal cartilages. In the inspiratory phase, the therapist gently pulls the points of contact and elevates the ribs. During exhalation, the therapist should deepen contact toward the inner costal margin, maintaining resistance. 25
Control Group Breathing exercises and prone positioning Two deep breaths/set four sets/session for each type of breathing exercises for three weeks 1-Diaphragmatic breathing with pursed lips breathing exercises 2-Breathing exercises with upper limb movement 3-Prone positioning 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- COVID-19 -Moderate illness -Women -Hemodynamic and respiratory stability -Acute respiratory failure requiring intubation and impaired consciousness. -Inability to collaborate with prone positioning. -O2 supplementation. -Smoking. -Other chest diseases as(COPD-asthma-tuberculosis-cancer. -Chest wall problems Adult: 19 Year-44 Year 35 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 17/05/2022 ethics committee of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
Ahmad Al zyat st. Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 6-MWD before and after the interventions
Secondary Outcome Chest expansion pre- and post-intervention
Secondary Outcome Barthel Index pre- and post-intervention
Secondary Outcome Oxygen saturation pre- and post-intervention
Secondary Outcome The Medical Research Council (MRC) dyspnea scale pre- and post-intervention
Secondary Outcome Fatigue Assessment Scale pre- and post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Damanhour National Medical Institute El-Gomhoreya St. Damanhour Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo University Al Gamaa St. Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Neven Nawar at Damanhour National Medical Institute El Gomhoreya St. Damanhour Egypt
Hossam Dabees at National Medical Institute El-Gomhoreya St. Damanhour Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad Ahmad ahmed.mahdy@pt.cu.edu.eg 002001007056624 Ahmad Al Zyat St.
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor of Physical Therapy for Cardiovascular and Respiratory Disorders at Cairo University
Role Name Email Phone Street address
Public Enquiries Neven Nawar nevennawar7@gmail.com 002001501706025 El-Gomhoreya St.
City Postal code Country Position/Affiliation
Damanhour Egypt Senior Physiotherapist at National Medical Institute
Role Name Email Phone Street address
Scientific Enquiries Ahmad Ahmad ahmed.mahdy@pt.cu.edu.eg 2001007056624 Ahmad Al Zyat St.
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor of Physical Therapy for Cardiovascular and Respiratory disorders 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
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