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.: PACTR201701001625186 Date of Approval: 08/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of exercise program in type 1 diabetic patients after autologus bone marrow stem cell transplantation
Official scientific title The effect of exercise program in type 1 diabetic patients after autologus bone marrow stem cell transplantation
Brief summary describing the background and objectives of the trial Stem cell therapy still remains in its infant stage, there are limited controlled trials in humans with diabetes mellitus, however rehabilitation in combination with stem cell therapy may augment its benefits, as exercise helps in enhancing the cell proliferation and neurogenesis, so according to the available informations,so the objective of this study will bestated in the following question:- Is there an effect of combined aerobic and resistance training in type 1 diabetic patients after autologous bone marrow stem cell transplantation?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,type 1 diabetic patients after autologous bone marrow stem cell transplantation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 30/12/2014
Actual trial start date 07/02/2015
Anticipated date of last follow up 12/08/2016
Actual Last follow-up date 12/08/2016
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 30
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomization using coin-tossing Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group exercise program 3/week 70 minutes aerobic and resisted training 15 Active-Treatment of Control Group
Control Group control group type 1 diabetic patients whom underwent autologus bone marrow stem cell transplantation 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-controlled type 1 diabetic patients after autologous bone marrow stem cell transplantation -Their age ranged between 15-30 -No other complication or diseases -uncontrolled patients -athletic patients -patients who missed 2 successive sessions 15 Year(s) 30 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 08/01/2015 Ethics Committee of Wadi El-Neel Hospital
Ethics Committee Address
Street address City Postal code Country
Wadi El-Neil Street next to El Kobba palace Cairo 02 Egypt
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 04/01/2015 Cairo University/Faculty of physical therapy/ Research Ethical committee
Ethics Committee Address
Street address City Postal code Country
Ahmed El-Ziaat El-Giza 03 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HbA1C, C-peptide level, insulin dosage, fasting and post prandial blood glucose level before and after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wadi El-Neel Hospital Wadi El-Neel street next to El Kobba palace Cairo 02 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Marwa Taher 20A mahatet el zeitoun street Cairo 02 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Wadi El-Neel Hospital Wadi El-Neel street next to El Kobba palace Cairo 02 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Awatef Labib Helwan Cairo 02 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Taher marwingo243@yahoo.com 01005056630 20A Mahatet El zietoun
City Postal code Country Position/Affiliation
Cairo 02 Egypt Physical therapist
Role Name Email Phone Street address
Public Enquiries Wessam Gamal El-Din alweee@yahoo.com 01004610453 20A Mahatet El zietoun
City Postal code Country Position/Affiliation
Cairo 02 Egypt Engenier
Role Name Email Phone Street address
Scientific Enquiries Rania Reda raniareda22@hotmail.com 01273325285 Geser El Suez
City Postal code Country Position/Affiliation
Cairo 02 Egypt Lecturer of physical therapy-faculty of physical therapy
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information