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.: PACTR201703002130225 Date of Approval: 24/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of intradialytic resisted exercise training program on some echocardiographic measures in hemodialysis patients
Official scientific title Effect of intradialytic resisted exercise training program on some echocardiographic measures in hemodialysis patients
Brief summary describing the background and objectives of the trial Chronic kidney disease (CKD) is an important epidemic and public health problem, and it occurs in many countries with an increasing prevalence. CKD has a progressive course and so associated with progression to end-stage renal disease (ESRD), Cardiovascular disease (CVD) and increased mortality rates. Patients with ESRD require renal replacement therapies (RRT) such as dialysis and renal transplantation. hemodialysis(HD) is the most common RRT used . Nowadays, more than two million people with renal failure are treated by HD worldwide. CVD is the major cause of death in HD patients. Change in left ventricle (LV) volume during dialysis will alter LV contraction and strain. The significant decreases in end-diastolic volume (EDV) and end systolic volume (ESV) after dialysis were clearly demonstrated by using 3-dimensional speckle tracking echocardiography. .physical activity is one of the key elements for the prevention of chronic diseases but the prescription of exercise for CKD patients is less usual than for other chronic diseases.Patients with CKD when subjected to resisted exercises(RE) show substantial improvements in many functions, especially those related to the Cardiovascular system, respiratory, muscular and QOL. But there was no available literature review founded about effect of resisted training on echocardiographic changes in patients undergoing regular HD. So there was a need to establish the efficacy of intradialytic resisted exercise training on echocardiography in patients on regular HD.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,heart disease, end stage renal disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/11/2013
Actual trial start date 01/03/2014
Anticipated date of last follow up 31/10/2015
Actual Last follow-up date 31/03/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL Effect of intradialytic resisted exercise training program on some echocardiographic measures in hemodialysis patients
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intradialytic resisted exercises 3 times per week 3 months moderate resisted exercises (50 -75 % of the one repetition maximum) for the big muscles of both lower limbs and free upper limb muscles from arteriovenous fistula was done under supervision in first 2 hours of hemodialysis session. it consisted of single and multiple-joint resistance exercises which was composed of 8 exercises, 3 sets of 12 repetitions and 2:3 minutes rest in-between sets. 20
Control Group regular hemodialysis session 3 times per week 3 months regular hemodialysis session 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ESRD or stage 5 CKD in which eGFR < 15 mL/min per 1.73 m² on maintenance HD for more than three months (greater than 12 weeks) and less than seven years when starting the study. Undergoing regular HD, three sessions per week (on alternate days), for four hours each session. Good compliance with dialysis treatment (not missing more than 2 dialysis sessions in the prior month). In a stable medical (clinical) and haemodynamic condition. Receiving HD through arm arteriovenous (A-V) fistulas and having no problems in it (based on the physician's diagnosis). Untrained at baseline and did not participate in any regular physical activity. Patients were on regular HD for less than three months or more than seven years. Patients who were irregular in dialysis sessions, not adherent to the exercise program or reluctance to continue participating in the exercises. Hospitalized during the prior month. Previous renal transplanted patients. Medically unstable : Uncontrolled arterial hypertension: resting [systolic blood pressure (SBP) ¿ 200 mm Hg and/or diastolic blood pressure (DBP) ¿ 120 mm Hg]. Hypotension (BP < 90/70) during HD sessions. Patient¿s hemoglobin less than 9 g/dL. Patients with chronic disorders (neurological, orthopedic or musculoskeletal disorders) BMI> 30 30 Year(s) 45 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 22/08/2013 faculty of physical therapy ethical committee in faculty of physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome left ventricle ejection fraction and left ventricle mass index initial point: before beginning the study follow up point:after three months
Secondary Outcome left ventricle end-diastolic diameter and left ventricle end- systolic diameter initial point: before beginning the study follow up point:after three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Kaser EL Aini nephrology and dialysis center in Al Kaser EL Aini Hospital Kaser AL Ainy street cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eman Abd El Halim villa 7- blk 19/15- 9th region- Gharb somid district 6 October- Giza 12566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eman Abd El Halim villa 7- blk 19/15- 9th region- Gharb somid district 6 October- Giza 12566 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
AZIZ GERGES AZIZ El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza giza 11432 Egypt
ESSAM BALIGH Kasr A Ainy st. cairo 11562 Egypt
SAHIER EL-KHASHAB Kasr A Ainy st. cairo 11562 Egypt
SHEREEN HAMED ELSAYED El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza Giza 11432 Egypt
Dina Ossama Labib Kasr A Ainy st. cairo 11562 Egypt
Reham Darwish Kasr Al Ainy st. cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Abd El Halim emmy_halim@yahoo.com 00201005204018 villa 7-blk 19/15- 9th region-Gharb somid discret
City Postal code Country Position/Affiliation
6 october- giza 12566 Egypt Phd student at faculty of physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries Eman Abd El Halim emmy_halim@yahoo.com 00201005204018 villa 7-blk 19/15- 9th region-Gharb somid discret
City Postal code Country Position/Affiliation
6 october- giza 12566 Egypt Phd student at faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries Eman Abd El Halim emmy_halim@yahoo.com 00201005204018 villa 7-blk 19/15- 9th region-Gharb somid discret
City Postal code Country Position/Affiliation
6 october- giza 12566 Egypt Phd student at faculty of physical therapy cairo university
REPORTING
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