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.: PACTR202006495227440 Date of Approval: 17/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of inspiratory muscle training on pulmonary function and functional capacity after mitral valve replacement
Official scientific title Effect of inspiratory muscle training on pulmonary function and functional capacity after mitral valve replacement
Brief summary describing the background and objectives of the trial Cardiac surgery is a highly complex procedure which generates worsening of lung function and decreased inspiratory muscle strength.These complications can lengthen the hospital stay of patients,causing increased hospital costs and becoming an important cause of morbidity and mortality. the purpose of this study is to investigate the effect of inspiratory muscle training on pulmonary function and functional capacity after mitral valve replacement.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/06/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 30/01/2020
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Regular Physiotherapy Protocol 20-30 min, once / daily 8 weeks Pre- op. physiotherapy education includes- 1- Pursed lip breathing exercises 2- Diaphragmatic breathing exercises 3- splinted cough 3- Leg ROM (active hip and knee flexion, extension and abduction exercises) 4- ankle toe movements exercises Post- op. physiotherapy will be given to both the experimental groups till hospital discharge, it includes- 1- Deep breathing exercises- 2- Pursed lip breathing exercises 3- Diaphragmatic breathing exercises 4- Segmental breathing exercises 5- Leg Range of motion exercises (active hip and knee flexion and extension exercises) 6- Ankle and toe movements 7- Ambulation program 10-15 min The frequency and repetition of exercises increased gradually after discharge according to patients' capabilities 50 Active-Treatment of Control Group
Experimental Group Inspiratory muscle training Regular Physiotherapy Protocol: 20-30 min; Once/ daily Inspiratory muscle training ; 10 Repetition x 3 sets x twice/ daily 8 weeks Before discharge from hospital :the participants receive the regular physiotherapy protocol in addition to inspiratory muscle training [10 Repetition x 3 sets x twice/ daily] After discharge: the participants receive the same physiotherapy protocol as control group in addition to inspiratory muscle training [10 Repetition x 3 sets x twice/ daily] 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- All participants underwent elective Mitral valve replacement -All participants have median sternotomy incision - All participants are clinically and medically stable - All participants have normal body mass index (BMI) - Age ranges (30-50 years ) - Over weight and obese patients (BMI mor than 30kg/m2) - post-operative renal failure - post- operative arrhythmia - patients with pacemaker - smokers - Chronic obstructive pulmonary disease (COPD) patients - Patients with hemodynamic instability after geting out from ICU - Patients who developed post-operative complication or readmitted to the ICU Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 50 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 30/05/2019 Research Ethics Committee of South valley university
Ethics Committee Address
Street address City Postal code Country
Qena - Safaga Rd, Qena Governorate, Egypt Qena 83523 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pulmonary function tests including Forced vital capacity (FVC), expiratory volume in one second (FEV1), forced expiration ratio (FEV1/FVC), Maximal Inspiratory Pressure (MIP) Pulmonary function tests were carried out pre-operative, post-operative after discharge from ICU , on the day of discharge from hospital and on the 8th post-operative week
Secondary Outcome 6 minute walk test the patient will be asked to walk far as possible for 6 minutes. pre-operative, after discharge from ICU, on the day of discharge from hospital and on the 8th pos-operative week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
South Valley University Hospitals Qena-Safaga Rd Qena Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Ali Mohamed Hassan Qena - Safaga Rd, Qena Governorate, Egypt Qena Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South Valley University Qena - Safaga Rd, Qena Governorate, Egypt Qena 83523 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Ali Mohamed Hassan Qena - Safaga Rd, Qena Governorate, Egypt Qena Egypt
Dr. Sarah Medhat Mohamed Giza, Egypt Giza Egypt
Dr. Emad Aboelnasr Kasr Eleiny st, Cairo Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Hassan ali311pt@svu.edu.eg 00201152332592 Qena - Safaga Rd, Qena Governorate, Egypt
City Postal code Country Position/Affiliation
Qena Egypt Lecturer of Physical Therapy Faculty of Physical Therapy South Valley University
Role Name Email Phone Street address
Public Enquiries Ahmed Abdelhamid ahmedsamir@svu.edu.eg 00201100330791 Qena - Safaga Rd, Qena Governorate, Egypt
City Postal code Country Position/Affiliation
Qena Egypt Lecturer of Physical Therapy For Musculoskeletal Disorders Faculty of Physical Therapy South Valley University
Role Name Email Phone Street address
Scientific Enquiries Mahmoud El Shazly mahmoud.elshazly311@svu.edu.eg 00201010865481 Qena - Safaga Rd, Qena Governorate, Egypt
City Postal code Country Position/Affiliation
Qena Egypt Lecturer of Physical therapy for Cardiopulmonary and Respiratory Disorders Faculty of Physical Therapy South Valley University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) includes demographic and clinical characteristics of the participants as well as the pre- and pos-intervention parameters measured in the trial Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol with in 12-18 months from study completion date and after publication of the study Data will be available upon signed request from the principal investigator [e-mail address: ali311pt@svu.edu.eg] within 12- 18 months from date of study completion.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
this platform will be updated after puplication 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