Cardiorespiratory fitness and cardiovascular autonomic control in patients with mild to moderate relapsing remitting Multiple sclerosis following 6 week endurance exercise program
In patients with MS, it remains unclear whether exercise improves autonomic control of the heart during exercise is effective or not. While the issue in heart disease, animal studies and human studies in healthy subjects has been proven. Because most MS patients have a rehabilitation programto improve exercise tolerance it should be considered to the effect of this intervention on cardiac autonomic control during exercise. Such a study can also show the causes of intolerance to exercise in MS patients and also effect of exercise on the etiologic factors. Assuming our hypothesis is that the improvement in cardiac autonomic control system with a short-term exercise on MS patients will be seen and associated with improvements in exercise tolerance would be such an increase. The small number of studies and different results prompted us to do this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100524370N1
Registration date:2015-11-13, 1394/08/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Alireza Aali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2611 2822
Email address
a-aali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cardiorespiratory fitness and cardiovascular autonomic control in patients with mild to moderate relapsing remitting Multiple sclerosis following 6 week endurance exercise program
Public title
Exercise effect on patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: definite diagnosis of MS; the MS patients must have passed at least one year of their diagnosis; patients beable to move and walk; age 18-50 years old; all subjects should be sedentary (less than 2 hours of physical activity during a week); they do not have to orthopedic and any chronic illness that not being able to exercise or have an effect on the cardio-pulmonary system; none of the samples should not take medicines that affect on HR.
Exclusion criteria: dementia; alcohol consumption; pregnancy; relapsing MS in a month to study; pacemaker or any disruptions or other serious cardiovascular and respiratory and orthopedic that prevents people from exercising their maximum limit; beta-blockers consumption.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina street, Keshavarz blvd.
City
Tehran
Postal code
Approval date
2015-07-11, 1394/04/20
Ethics committee reference number
ir.tums.rec.1394.362
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating disease of the central nervous system
Primary outcomes
1
Description
Cardiorespiratory fitness and cardiovascular autonomic contro
Timepoint
Before and 6 weeks after intervention
Method of measurement
cardiopulmonary exercise test
Secondary outcomes
1
Description
The effect of aerobic exercise on fatigue variables
Timepoint
Before and 6 weeks after intervention
Method of measurement
Fatigue questionnaire
2
Description
Effects of aerobic training on EDSS variables
Timepoint
Before and 6 weeks after intervention
Method of measurement
Krutze criteria
3
Description
The effect of aerobic exercise on respiratory function such as: Vo2/HR, O2 pulse, PETCO2, PETO2, Vd/vt, vt, RR, VE, Vco2 peak RER, VE/VCO2
Timepoint
Before and 6 weeks after intervention
Method of measurement
Cardiopulmonary exercise tes
4
Description
The effect of aerobic exercise on walking capacity variables
Timepoint
Before and 6 weeks after intervention
Method of measurement
Questionnaire about physical activity (IPAQ
Intervention groups
1
Description
Endurance training intervention for HR - controlled at 50 - 60 rpm is in a lactate threshold. (Equivalent to 70% HR peak or 60% vo2 peak) on a 6-week cycle is carried out and CPET testing and EKG will be done againat the end . Sessions under supervision, at least 5 times training sessions during two week under the supervision. the subjects must be participate at least 9 Sessions .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Maryam Abolhasani
Street address
Sina hospital, Imam Khomeini st., Hasan Abad squa.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Tehran Enghelab Street goce Street Poursina street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Reza Aali
Position
MD, Sports medicine assistant
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 2611 2822
Fax
Email
a-aali@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mamryam Abolhasani
Position
Sports medicine specialist
Other areas of specialty/work
Street address
Sina hospital, Imam Khomeini st., Hasan Abad square
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
m_abolhasani@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Abolhasani
Position
Sports medicine specialist
Other areas of specialty/work
Street address
Sina hospital, Imam Khomeini st., Hasan Abad square
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
m_abolhasani@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)