The main objective of this clinical trial is to compare the effect of passive and active exercise during dialysis on the adequacy and complications of hemo-dialysis. The inclusion criteria includes the age between 15 and 70 years old, hemo-dialysis for at least 3 months and negative history of cardiovascular disease. The patients that show arrhythmia during exercise will be excluded from the study. The patients referring to the Akhavn hospital in Kashan city will be recruited to this study. The 40 patients will be randomly divided into the active and passive exercise grops. The study methods will be described for patients. Both groups will be done dialysis by filter High Flux,Blood flow velocity 350 cc per minute, Dialysis solution velocity 500 cc per minute for 8 weeks. Exercise will be started of the week 9 and will be continued until week 16. Active group will be done exercise by pedaling minibike for 60 minutes within the first two hours of dialysis. The exercise sessions will be divided to 10 minutes of exercise and 10 minutes of rest. Passive group will be done exercise by the electronic minibike in the same manner. Blood pressure will be measured at the beginning and the end of each hour of dialysis.The adequacy of dialysis, phosphorus, calcium, sodium and potassium will be measured at the end of 8 and 16weeks and will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210316228N4
Registration date:2012-11-26, 1391/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-26, 1391/09/06
Registrant information
Name
Negin Masoudi Alavi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
masudialavi_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intra-dialytic active and passive exercise on dialysis adequacy and complications
Public title
The effect of active and passive exercise on dialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age between 15 to 70 years old; treated with hemodialysis for more than three months; treated by hemodialysis three times per week for at least 4 hours in every session; Negative history of cardiovascular disease; Negative history of myocardial infarction in previous 6 months; Negative history of stroke; Negative history of chronic pulmonary disease; Negative history of musculoskeletal disease and autoimmune diseases.
Exclusion criteria: The cardiac arrhythmia during exercise which need anti-arrhythmia drugs; the poor corporation of the patient; experiencing any problem during exercise.
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotb Ravandi Highway
City
Kashan
Postal code
8715981151
Approval date
2012-07-26, 1391/05/05
Ethics committee reference number
1910/1/5/29/پ
Health conditions studied
1
Description of health condition studied
dialysis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis
Primary outcomes
1
Description
Blood pressure
Timepoint
beggining of the study and final per hour of hemodialysis
Method of measurement
blood pressure measurement cuff
2
Description
Calcium
Timepoint
beginning of the study
Method of measurement
blood electrolytes analysis
3
Description
phosphoros
Timepoint
beginning of the study
Method of measurement
blood electrolytes analysis
4
Description
potassium
Timepoint
beginning of the study
Method of measurement
blood electrolytes analysis
5
Description
sodium
Timepoint
beginning of the study
Method of measurement
blood electrolytes analysis
6
Description
adequacy of dialysis
Timepoint
beginning of the study
Method of measurement
adequacy of dialysis formula
Secondary outcomes
empty
Intervention groups
1
Description
Active exercise by pedaling a mini bike for 1 hour in 10 minutes intervals during the beginning two hours of the hemodialysis
Category
Treatment - Other
2
Description
Passive exercise with electronic bike for 1 hour in 10 minutes intervals during the beginning two hours of the hemodialysis
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Zahra sadat Mosavian
Street address
Panzdah Khordad Square, Akhavan Hospital
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Negin Masoudi Alavi
Street address
Ghotb Ravandi Highway, Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Negin Masoudi Alavi
Position
Faculty member
Other areas of specialty/work
Street address
Ghotb Ravandi Highway, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
masudialavi_N@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Negin Masoudi Alavi
Position
Ph.D
Other areas of specialty/work
Street address
Ghotb Ravandi Highway, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
masudialavi_N@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Negin Masoudi Alavi
Position
Faculty Member
Other areas of specialty/work
Street address
Ghotb Ravandi Highway, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
masudlalavi_N@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)