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.: PACTR201903732765841 Date of Approval: 22/03/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Peripheral Neuropathy in Type-II Diabetes Mellitus on Outcome Measures of Weight-Bearing Aerobic Training in Post-Myocardial Infarction Patients.
Official scientific title Impact of Peripheral Neuropathy in Type-II Diabetes Mellitus on Outcome Measures of Weight-Bearing Aerobic Training in Post-Myocardial Infarction Patients.
Brief summary describing the background and objectives of the trial Purpose: To define the effect of diabetic peripheral neuropathy (DPN) on the outcome measures of outpatient exercise based-cardiac rehabilitation (EB-CR) program in post-myocardial infarction (MI) patients with type-II diabetes mellitus (DM). Methods: Thirty post-MI patients with type-II DM were enrolled in the study within 1-6 months of MI. Fifteen patients attended 8 weeks of aerobic training program (exercise group; 12 men and 3 women) while 15 patients did not (control group; 11 men and 4 women). The exercise group was assessed for the presence of peripheral neuropathy and patients were accordingly subdivided into those with DPN "group A" and those without "group B". All groups were evaluated at baseline and at the end of the study. Evaluation included Duke Activity Status Index (DASI) questionnaire, 6-minute walk test, and symptom-limited treadmill exercise stress test (EST). Outcome measures included DASI score; 6-minute walk test distance (6MWD); and heart rate (HR), blood pressure (BP), rate pressure product (RPP), and functional capacity in metabolic equivalents (METs) measured during EST.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/03/2016
Actual trial start date 02/04/2016
Anticipated date of last follow up 06/01/2018
Actual Last follow-up date 05/05/2018
Anticipated target sample size (number of participants) 35
Actual target sample size (number of participants) 37
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rehabilitation Exercise based-cardiac rehabilitation: Sessions were 3 days/week, Warm up (10 minutes), Aerobic exercise (30 - 60 minutes/session), Cool down (10 minutes) for 8 weeks (24 session) The session included: (1) Warm up (10 minutes): stretching exercises. (2) Aerobic exercise training using treadmill (30 - 60 minutes/session): with target heart rate (HR) at 45 – 75% of HR reserve.(3) Cool down (10 minutes): light intensity treadmill walking. 20
Control Group None 8 weeks follow up Controls were advised to maintain their medications and regular activities of daily living. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study population included post-MI patients with type-II DM within 1 to 6 months from onset of MI. Patients were excluded if they had any contraindication to exercise stress test (EST) or CR, systemic illness other than DM or hypertension, neurological disorders other than DPN, or had loss of protective sensation (anesthesia) and/or ulcerations in the lower limbs. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 37 Year(s) 62 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 24/01/2016 Ethics committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria Alexandria 00123 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Outcome measures were DASI score, Six-minute walk test distance (6MWD), functional capacity in metabolic equivalents (METs), HR, blood pressure (BP) and rate pressure product (RPP) at a given workload. After completion of 8 weeks of exercise based- cardiac rehabilitation
Secondary Outcome Define the effect of DPN on the outcome measures of the outpatient EB-CR program (phase II) in post MI patients with type-II DM. After completion of 8 weeks of exercise based- cardiac rehabilitation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiology department Faculty of Medicine Alexandria University Medan Elkhartoum, Sultan Hussein street Alexandria 00123 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Faculty of medicine, El-khartoom Square, El-Azaritah, Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Cardiology and Department of Physical Medicine and Rehabilitation Medan Elkhartoum, Sultan Hussein Street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Diaa Mohamed Mohasseb Faculty of medicine, El-khartoom Square, El-Azaritah Alexandria Egypt
Mahmoud Mohamed Hassanein Faculty of medicine, El-khartoom Square, El-Azaritah Alexandria Egypt
Gihan Younis El tantawi Faculty of medicine, El-khartoom Square, El-Azaritah Alexandria Egypt
Aya Hanafy Ibrahiem Faculty of medicine, El-khartoom Square, El-Azaritah Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya Ibrahiem ayadiab89@yahoo.com +201222600212 Faculty of medicine, El-khartoom Square, El-Azaritah,
City Postal code Country Position/Affiliation
Alexandria Egypt Teaching assistant
Role Name Email Phone Street address
Public Enquiries Yousra Abdel Fattah yousrahisham@gmail.com +201227320303 Faculty of medicine, El-khartoom Square, El-Azaritah,
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Gihan El tantawi gihan_younis@yahoo.com 00201111646460 Faculty of medicine, El-khartoom Square, El-Azaritah,
City Postal code Country Position/Affiliation
Alexandria Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary and abstract of research Study Protocol available controlled, quality of request
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