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.: PACTR202105472866446 Date of Approval: 17/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between high-load and low-load postoperative inspiratory muscle training after cardiac surgeries
Official scientific title investigating and comparing the efficacy of high-load and low-load postoperative inspiratory muscle training on pulmonary function, inspiratory muscle strength and functional capacity after cardiac surgeries: A randomized controlled trial
Brief summary describing the background and objectives of the trial Although, pre-operative inspiratory muscle training (IMT) has been investigated and reported to be an effective strategy to reduce postoperative pulmonary complications, the efficacy of postoperative IMT as well as the proper load, frequency, and duration necessary to reduce the postoperative pulmonary complications has not been fully investigated. the purpose of this study is to investigate and compare the efficacy of high-load and low load inspiratory muscle training on the pulmonary function, inspiratory muscle strength and functional capacity after cardiac surgeries
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 02/03/2021
Actual trial start date 03/05/2021
Anticipated date of last follow up 04/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants)
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 Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional protocol 20-30 min; twice daily till discharge from hospital. After discharge the patients were invited to the department of physiotherapy to continue the rehabilitation protocol for 20-30 min; 3 sessions/ week till the end of the study protocol (8 weeks) 8 weeks Pre- op. physiotherapy education includes- 1-Pursed lip breathing exercises; 2- Diaphragmatic breathing exercises 3- splinted cough 4- Leg ROM (active hip and knee flexion, extension and abduction exercises); 5- ankle toe movements exercises. Post- op. physiotherapy will be given to both the experimental and control 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 60 Active-Treatment of Control Group
Experimental Group High load IMT Traditional Physiotherapy Protocol: 20-30 min; Once/ daily Inspiratory muscle training ;20-30 min; 10 Repetition x 3 sets x twice/ daily; starting load of 40% of the pre-operative MIP till discharge from hospital the load increased incrementally weekly by 5 % of the pre-operative MIP till reaching the target MIP of 80% of the pre-operative level 8 weeks Before discharge from hospital :the participants receive the traditional 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 3 sessions / week] 60
Experimental Group Low Load IMT Traditional Physiotherapy Protocol: 20-30 min; Once/ daily Inspiratory muscle training: 20-30 min; 10 Repetition x 3 sets x twice/ daily starting load with 20% of pre-operative MIP before discharge from hospital After discharge: 20-30 min, 10 Repetition x 3 sets x 3 sessions /week the training load increased incrementally on weekly basis by 5% of the pre-operative MIP till reaching the target final load of 60% of the pre-operative MIP 8 Weeks Before discharge from hospital :the participants receive the traditional physiotherapy protocol in addition to inspiratory muscle training [20-30 min;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 [20-30 min; 10 Repetition x 3 sets x 3 sessions/week] 60
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 (35-60) years - Over weight and obese patients (BMI mor than 30kg/m2) - postoperative renal failure - postoperative arrhythmia - patients with pacemaker - smokers - Chronic obstructive pulmonary disease (COPD) patients -Patients with hemodynamic instability after discharge 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) 35 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 01/03/2021 Committee of Ethics for Physical Therapy researches of the Faculty of Physical Therapy South Valley University
Ethics Committee Address
Street address City Postal code Country
Qena - Safaga Rd, Qena Governorate, Qena 83523 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pulmonary function pre operative, first day in the inpatient ward, on day of discharge from hospital, 4 weeks from surgery, 8 weeks from surgery
Primary Outcome inspiratory muscle strength pre-operative, first day in the inpatient ward, on day of discharge from hospital, 4 weeks from surgery, 8 weeks from surgery
Secondary Outcome Functional capacity pre-operative, on day of discharge from hospital, 4 weeks from surgery, 8 weeks from surgery
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, 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 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Ali Hassan Qena - Safaga Rd, Qena Governorate Qena Egypt
Dr. Sarah Medhat Mohamed kamel Giaza, Egypt Giza Egypt
Dr.Emad Aboelnasr Kaser Al-Ainy st, Cairo Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Hassan ali311pt@svu.edu.eg 00201003075678 Qena- Safaga road, Egypt
City Postal code Country Position/Affiliation
Qena Egypt Lecturer of Physical Therapy Faculty of Physical Therapy South Valley University Qena Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdelhamid ahmedsamir@svu.edu.eg 00201100330791 Qena- Safaga Road, 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
Public Enquiries Mahmoud ElShazly mahmoud.elshazly311@svu.edu.eg 00201010865481 Qena-Safaga Road
City Postal code Country Position/Affiliation
Qena Egypt Lecturer of Physical therapy forCardiopulmonary and RespiratoryDisorders Faculty of PhysicalTherapy South Valley University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to share IPD. 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 will be shared Clinical Study Report,Statistical Analysis Plan,Study Protocol within 12-18 months from the study completion date and after publication of the study Data will be available upon reasonable 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 publication 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