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.: PACTR202005730797920 Date of Approval: 04/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Influence of Selected Aerobic Exercises in Patients with Multiple Sclerosis
Official scientific title Influence of Selected Aerobic Exercises in Patients with Multiple Sclerosis
Brief summary describing the background and objectives of the trial Purpose of the study : To determine the effects of physiotherapy interventions with vitamin D supplementation In people with early stages of multiple sclerosis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 15/01/2019
Actual trial start date 15/01/2019
Anticipated date of last follow up 13/04/2019
Actual Last follow-up date 13/04/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
Publication URL P.T.REC/012/002176
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 physical therapy twice weekly 3 months conventional medical treatment of MS( Beta interferons ,Fingolimod Gilenya) /vitamin D supplementation 15 Active-Treatment of Control Group
Experimental Group physical therapy twice weekly 3 months conventional medical treatments of MS (Fingolimod (Gilenya),Beta interferons)/vitamin D supplementation/generalized lower limb strengthening exercises 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: 1. Relapsing remitting MS recently diagnosed 2. Age range from 20-40 (P fleger CCH F. E.-H., 2010) 3. EDSS (Expanded Disability Status Scale) score less than 5 4. Vitamin D insufficiency less than 20- 30 ng/mL. 1-Use of vitamin D supplements in the past 3 months. 2-Additional illness that would restrict their function, or suffered from a relapse within the last 4 months, as defined by Polman (Polman et al., 2011). 3-Relapse of disease and corticosteroids use in past month 4-Active inflammation at the start of the study (flu, cystitis etc.) 5-Renal disease 6-Elevated levels of calcium or parathyroid hormone 7-Switching of imunomodulatory drug in past 3 months 8-Hypersensitivity to vitamin D preparations 9-Cognitive impairment interfering with the subject’s ability to provide informed consent. 10-History of hyperparathyroidism, liver disease, tuberculosis, sarcoidosis and kidney stones (Lassmann, h 1999). Adult: 19 Year-44 Year 20 Year(s) 40 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 01/01/2019 research ethics team faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzayat st dokki/gia cairo 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome serum vitamin D level after completation of treatment
Secondary Outcome timed 25 walk test for lower limb functional improvement after completation of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university hospitals kasr aini medical school 27 Nafezet Sheem El Shafaey St Kasr Al Ainy cairo 11865 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
soher mohamed monir hamza 27 Nafezet Sheem El Shafaey St Kasr Al Ainy cairo 11865 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor soher mohamed monuir hamza dokki/giza giza 11865 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator soher hamza soheirhamza@gmail.com 00201007210261 dokki
City Postal code Country Position/Affiliation
giza Egypt physical therapist practioner
Role Name Email Phone Street address
Public Enquiries Abeer abu bakr dr.abeerelwishy2011@gmail.com 01228088835 nasr city
City Postal code Country Position/Affiliation
cairo Egypt profesor at faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries enas abu taleb enas_abutaleb@yahoo.com 00201001468054 nasr city
City Postal code Country Position/Affiliation
cairo Egypt assistant professor faculty of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 30 patients (male/female) were recruited to the study having multiple sclerosis (MS) aged from 20 :40 . Informed Consent Form 2 days controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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