Objective : The Effect of Intradialytic Aerobic Exercise on Dialysis Efficacy,inflamatory factors , in hemodialysis patients;
Study design:
Randomized controlled trial, phase II trial;
Inclusion criteria: patients who have been on dialysis for at least three months;
Exclusion criteria: lack of exercise capabilities for any reason, reluctance to exercise, uncontrolled heart disease;
Sample size: 50; 25 case, 25 control
Intervention: The patients in exercise(case) group exercise during dialysis for six months;and patient in control group performed dialysis without exercise.
duration of intervention: 6 months;
Primary outcome: Blood pressure and inflammatory markers in people who exercise during dialysis, be lower than the control group and dialysis efficacy is better in exercise group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092324152N1
Registration date:2016-12-01, 1395/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-01, 1395/09/11
Registrant information
Name
Maryam Tajfar
Name of organization / entity
Arak Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3417 3603
Email address
tajfar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intradialytic Exercise on Blood Pressure, Inflamatory Factors and Dialysis Efficacy in Hemodialysis Patients
Public title
Effect of Exercise on Hemodyalisis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:underwent hemodialysis for at least 3mounths; hemodialysis session for 3 times a week;25-65 years;no musculoskletal impairmen;no myocardial infarction in recent 30days;hemodinamically stable;ability to read & write ;no drug consumption that interference with sleep;no vision or hearing loss
exclusion criteria:limb amputation;unable to use stationary bike;unable to perform more than 70% of exercise program;cardiac problem during exercise program;uncontrolled dabetes mellitus;pregnancy;cerbrovascular accident;metabolic disorder such as: hypothyroidie , anemia;neurologic disorder such as: parkinsonism, amyolatral sclerosis,myopathy sever neuropathy
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Arak Univercity of Medical Science Ethics committee
Street address
Facualy of Medicin, Arak Univercity of Medical Science, Basij Square, Arak, Markazi Province, Iran
City
Arak
Postal code
3848176941
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
9316924
Health conditions studied
1
Description of health condition studied
chronic dialysis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis
Primary outcomes
1
Description
Decrease Blood Pressure
Timepoint
During Trial
Method of measurement
Digital Manometer
2
Description
Decrease CRP
Timepoint
During Trial
Method of measurement
ELIZA
3
Description
Improve Dialysis Efficacy
Timepoint
During Trial
Method of measurement
Special Formula
Secondary outcomes
empty
Intervention groups
1
Description
Intradialytic Exercise
Category
Rehabilitation
2
Description
control: No Exercise
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Street address
Valiasr Hospital, Valiasr Square, Arak, Markazi Province, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Arak University of Medical Science
Full name of responsible person
Mohammad Rafie
Street address
Vice Chancellor of Research, Arak Univercity of Medical Science, Basij Square, Arak, Markazi Province, Iran
City
Markazi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Arak University of Medical Science
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
Arak University of Medical Science
Full name of responsible person
Soltani Parvin
Position
Nephrologist
Other areas of specialty/work
Street address
Facualy of Medicin, Arak Univercity of Medical Science, Basij Square, Arak, Markazi Province, Iran
City
Arak
Postal code
Phone
+98 86 3417 3514
Fax
Email
soltaniparvin@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak Univercity of Medical Science
Full name of responsible person
Soltani Parvin
Position
Nephrologist
Other areas of specialty/work
Street address
Facualy of Medicin, Arak Univercity of Medical Science, Basij Square, Arak, Markazi Province, Iran
City
Arak
Postal code
Phone
+98 86 3417 3514
Fax
Email
soltaniparvin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak Univercity of Medical Science
Full name of responsible person
Maryam Tajfar
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
facualy of medicine, Arak Univercity of Medical Science, Basij Square, Arak, Markazi Province, Iran
City
Arak
Postal code
76941-38481
Phone
+98 86 3417 3514
Fax
Email
maryam_tajfar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)