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.: PACTR201802003044246 Date of Approval: 04/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Incentive spirometer effect on diaphragmatic excursion in hemodialysis
Official scientific title Effect of Incentive Spirometer Training on Diaphragmatic Excursion and Quality of Life in Hemodialysis Patients
Brief summary describing the background and objectives of the trial This study will explore the effect of a program of incentive spirometer training on diaphragmatic excursion and quality of life in patients on hemodialysis .
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic kidney diseases,Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 14/09/2017
Actual trial start date 01/11/2017
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date 23/01/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Hemodialysis only 3 times per week 4 hours this control group was maintained on hemodialysis only 30 Uncontrolled
Experimental Group Incentive spirometer training during hemodialysis session 3 times per week 1/2 an hour during hemodialysis session the patient sat upright with placing of incentive spirometer on a table or bed at the same level of patient mouth , breathe out normally , put the mouthpiece in patient's mouth and tightly seal patient's lips around it , breathe in slowly and deeply , this will raise the balls to the top of the column , hold the breath as long as possible ( at least five seconds ) , 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients will be included if they meet the following criteria : 1. Age between 45¿ 55 years. 2. Both sexes included . 3. Patients with grade 5 chronic renal failure on hemodialysis . 4. They will be medically and psychologically stable. 5. Receiving their physician-prescribed pharmacotherapy regularly. 6. Agree to participate by signing an informed consent form Patients will be excluded if they have any of the following criteria: 1. Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia . 2. patients with unstable angina, uncontrolled cardiac arrhythmia , decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg , persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis . 3. acute systemic infection . 4. Presence of malignant disease. 5. Patients with Diabetes Mellitus . 6. Patients with Lupus Nephritis . 7. Patients with any Lung diseases . 40 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 10/09/2017 Faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
Faculty of physical therapy , Cairo university Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in diaphragmatic excursion - At the beginning of the study - After 2 months
Secondary Outcome Functional capacity -at the beginning of the study -after 2 months
Secondary Outcome Quality of life ( SF36 survey ) -at the beginning of the study -after 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The National Institute of Urology and Nephrology elmatareya St cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Not found cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Not found cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
No collaborators cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hala Mohammed ezzeldein hala.ezzeldein@pt.cu.edu.eg +201006626043 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 12521 Egypt Professor of physical therapy for cardiovascular/ Respiratory Disorder and Geriatrics
Role Name Email Phone Street address
Public Enquiries Fatma abo-elmagd Fatma.aboelmagd@pt.cu.edu.eg +201111155719 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 12521 Egypt Assistant professor of physical Therapy for Cardiovascular/ Respiratory Disorder and Geriatrics
Role Name Email Phone Street address
Scientific Enquiries Tarek Fakhr-eldeen Othman Tarek.fakhr@yahoo.com +201066426125 4 El Horreya St.¿ El-Bostan, Heliopolis, Cairo Governorate
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of internal medicine and nephrology at the national institute of urology and nephrology
REPORTING
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