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.: PACTR201707002364200 Date of Approval: 19/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Inspiratory Muscle Training versus Resistance Training on ventricular dysfunction for patients with Dilated Cardiomyopathy: Randomized Contr
Official scientific title Inspiratory Muscle Training versus Resistance Training on ventricular dysfunction for patients with Dilated Cardiomyopathy
Brief summary describing the background and objectives of the trial Dilated cardiomyopathy is a common clinical response to many prolonged diverse cardiac insults.Despite advances in clinical management, exercise therapy still widely used as an adjuvant therapy for patients with heart failure from different etiologies .the main objective of this study is to investigate the effect of inspiratory muscle training compared with resistance training on left ventricle dysfunction for patients with dilated cardiomyopathy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Dilated Cardiomyopathy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 02/06/2015
Actual trial start date 10/08/2015
Anticipated date of last follow up 26/07/2016
Actual Last follow-up date 15/08/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
The Universal Trial Number (UTN) is U1111-1198-0623
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Inspiratory muscle training 3 days / week 16 weeks at 40% of maximal inspiratory pressure for 28 minutes once a day 15 Uncontrolled
Experimental Group Resistance training 3 sets /session-3 days/ week 16 weeks 50-60% of one maximum repetition 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-patients with global dilation of left ventricle at the echocardiogram, New York Heart Association (NYHA) class II-III, 2-clinically stable without change in medication for last 30 days prior the study , 3-left ventricular end-diastolic dimension > 5.5cm and end-systolic diameter > 4.5cm, 6-left ventricular ejection fraction < 45%. Chronic heart failure due to other causes, valvular disease requiring surgery, participating in other trials including physical exercise, chronic obstructive pulmonary disease, recent myocardial revascularization and disorders in the musculoskeletal system or other organs complicating physical activity and exercise training 48 Year(s) 56 Year(s) Male
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 12/03/2015 local ethics committee
Ethics Committee Address
Street address City Postal code Country
Wadi El-Neel Hospital Cairo 31333 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Left ventricular end Diastolic diameter LVEDD baseline after 16 weeks after 24 weeks follow up
Primary Outcome and left ventricular ejection fraction (LVEF %) baseline, after 16 weeks, after 24 weeks follow up
Primary Outcome Left ventricular end Diastolic diameter LVEDD baseline after 16 weeks after 24 weeks follow up
Primary Outcome and left ventricular ejection fraction (LVEF %) baseline, after 16 weeks, after 24 weeks follow up
Primary Outcome Left ventricular end systolic diameter LVESD baseline, after 16 weeks, after 24 weeks follow up
Primary Outcome peak oxygen uptake(peakVO2) baseline, after 16 weeks, after 24 weeks follow up
Primary Outcome and ventilatory equivalent of CO2 at anaerobic threshold ( EqCO2 at AT) baseline, after 16 weeks, after 24 weeks follow up
Primary Outcome Maximum inspiratory pressure (IPMAX) baseline, after 16 weeks, after 24weeks follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wadi El-Neel Hospital the outpatient clinic of the Physical Medicine and Rehabilitation Department Cairo 4543 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wadi El Neel hospital Wadi El Neel street Cairo 4543 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Azza Atya Cairo university Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shereen Hamed Elsayed Shreen317@yahoo.com 01093310723 7 Ahmed El Zayyat ,Dokii
City Postal code Country Position/Affiliation
Giza 31333 Egypt PhD of physical therapy, Faculty of Physical Therapy, Cairo University.
Role Name Email Phone Street address
Public Enquiries Azza Mohamed Atya Azzaatya73@cu.edu.eg 01005208479 7 Ahmed El Zayyat , Dokii
City Postal code Country Position/Affiliation
Giza 31333 Egypt Assistant professor of Physical Therapy, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Mohamed Nasser Mahmoud73nasser@hotmail.com 01005173213 Wadi El-Neel Hospital street
City Postal code Country Position/Affiliation
Cairo 12613 Egypt PhD of physical therapy, head of the rehabilitation department, wadi El-Neel Hospital
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information