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.: PACTR201609001724102 Date of Approval: 24/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title balance training in Hemodialysis
Official scientific title Specific balance training mixed with endurance-resistance exercise program improves postural balance in elderly patients undergoing Hemodialysis.
Brief summary describing the background and objectives of the trial The purpose of this study was to evaluate the effects of six months of specific balance training included in endurance-resistance program on postural balance in Hemodialysis patients (HD).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic kidney disease,Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 02/02/2015
Actual trial start date 10/03/2015
Anticipated date of last follow up 10/08/2015
Actual Last follow-up date 10/10/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 49
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 Randomised Simple randomisation using a radomisation table created by a computer software program Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group balance training group 4 sessions weekly 6 months Balance training Training sessions lasted 30 min and were monitored by health professionals. The content of the balance-training program was developed based on the previous studies with others chronic diseases and guidelines for fall prevention in elderly patients 26
Control Group endurance resistance training group four sessions weekly SIX MONTHS Resistance training consisted of dynamic strengthening exercises. Quadriceps muscles, pectoral muscles, triceps brachia muscles biceps brachia muscles and hamstrings were trained on a multigym. Patients started at 50% of the initial one-repetition maximum (1RM: the maximum load which can be moved only once over the full range of motion without compensatory movements) in the first week. Every month 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
absence of chronic respiratory and cardiac diseases, at least one fall in the previous six months, absence of neurological or musculoskeletal disorder with affected postural control Patients who were participate in a physical rehabilitations program in the last year or who used assistive device in walking were excluded from our study 60 Year(s) 70 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 25/03/2015 ethics committee OF MONASTIR HOSPITAL
Ethics Committee Address
Street address City Postal code Country
Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Timed Up and Go test at baseline after six months of the training program
Primary Outcome TINETTI TEST at baseline after six months of the training program
Primary Outcome BBS SCALE at baseline after six months of the training program
Primary Outcome UST TEST at baseline after six months of the training program
Primary Outcome ABC SCALE at baseline after six months of the training program
Primary Outcome MINI BEST TEST at baseline after six months of the training program
Secondary Outcome SIX MINUTES WALK TEST at baseline after six months of the training program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
nephrology and internal medicine service CHU Monastir Tunisia 22 Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
FACULTY OF MEDECINE MONASTIR Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medecine of monastir Ave Ali Bourguiba,Skanes monastir 4000 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Wajdi Mkacher Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
Ameur Frih Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
Zohra ben Salah Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
Mezry. El May Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
Mohamed. Hammami Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia MONASTIR 5000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator BECHIR FRIH frih.bechir@gmail.com 22875172 Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia
City Postal code Country Position/Affiliation
MONASTIR 5000 Tunisia
Role Name Email Phone Street address
Public Enquiries WAJDI MKACHER wajdi_mkacher@yahoo.fr 54822519 Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia
City Postal code Country Position/Affiliation
MONASTIR 5000 Tunisia
Role Name Email Phone Street address
Scientific Enquiries WAJDI MKACHER wajdi_mkacher@yahoo.fr 54822519 Ave Ali Bourguiba,Skanes, 5000, Monastir, Tunisia
City Postal code Country Position/Affiliation
MONASTIR 5000 Tunisia
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