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.: PACTR201601001415135 Date of Approval: 07/01/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Muscle Force Output response For Different Fatiguing Factors
Official scientific title Muscle Force Output response For Different Fatiguing Factors
Brief summary describing the background and objectives of the trial The factors that contribute to fatigue from voluntary activity are numerous and in complex multifactorial process. Theoretically every step in the chin that leads eventually to muscular contraction has been studied under a variety of circumstances. As a result, many theories of fatigue have been discussed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 07/01/2016
Actual trial start date 09/01/2016
Anticipated date of last follow up 29/01/2016
Actual Last follow-up date 30/01/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 simple random envelopes Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group one both voluntary and electrically induced fatiguing protocols on left limb, while the right limb underwent electrically induced fatiguing protocol, 30 min both voluntary and electrically induced fatiguing protocols on left limb, while the right limb underwent electrically induced fatiguing protocol, 30
Control Group group two both voluntary and electrically induced fatiguing protocols on left, while the right limb underwent voluntary induced fatiguing protocol. 30 min both voluntary and electrically induced fatiguing protocols on left, while the right limb underwent voluntary induced fatiguing protocol. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Their ages ranged from (18 - 40) years Subjects were refrained from taking substance containing caffeine (tea, coffee, cola,¿..etc), alcohol or aspirin for 12 hours have no muscular or neuromuscular disease 18 Year(s) 40 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 06/01/2016 faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
ahmed el ziat street giza 98745 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome maximum voluntary contraction on isokinetic machine after test protcol
Secondary Outcome lactic acid, CPK Each subject gave a blood sample before and after each fatiguing protocol.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic , faculty of physical therapy el ziat st giza 78945 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy ahmed el ziat street giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university ahmed el ziat street giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahmoud mohamed ewidea ahmed el ziat street giza Egypt
Ahmed elerian madii cairo Egypt
osama khaled taiba cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sameh ahmed samehrefat@hotmail.com 0125522478 tahrir
City Postal code Country Position/Affiliation
giza 44561 Egypt Ph.D
Role Name Email Phone Street address
Public Enquiries ahmed elerian dr_ahmed_elerian@hotmail.com 0124578940 madii
City Postal code Country Position/Affiliation
cairo Egypt Ph.D
Role Name Email Phone Street address
Scientific Enquiries mahmoud ewidea mewidea@hotmail.com 00201288280082 3 elwehda
City Postal code Country Position/Affiliation
giza 33512 Egypt Ph.D
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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