Parkinson's disease (PD) is one of the most common progressive neurodegenerative disorders. Physical exercise takes into account an important protective approach to prevent abnormal function and cell death in the brain. Beneficial effects including molecular changes in the brain to increase memory and learning might reduce apoptosis in Retinal cells. Therefore, it is important to seek more effective therapeutic interventions as well as low-cost ones for PD. In this study, the mechanism of its effect in PD and its animal model will be considered.
Design
A clinical trial with a control group, parallel groups, triple-blind, randomized
Settings and conduct
First, patients are selected according to entry (inclusion) criteria and then therapeutic sessions are arranged. After receiving the consent form from the individuals, their group will be determined completely randomly. Then, initial assessments (cognitive, visual, and motor function) will conduct. After the tests, the presence time of the patients for the exercises will be coordinated.
Participants/Inclusion and exclusion criteria
People diagnosed with Parkinson's Disease
Ability to perform the hardest level of laboratory tests
Intervention groups
Intervention group:The exercise program is consisted three categories of cognitive exercises(with emphasis on memory and attentional tasks),motor exercises(with emphasis on balance),and visual training (with emphasis on voluntary and anti-saccadic movements).24 training sessions are based on two principles of the challenge and individual's safety items.The duration of exercises will be provided in 45 to 60-minutes in each session and 3 sessions per week.
Control group:The control group will not receive any specific training.
Main outcome variables
Physical exercises can affect cognitive, visual, and motor functions in people with Parkinson's disease.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140612018077N2
Registration date:2018-10-24, 1397/08/02
Registration timing:prospective
Last update:2018-10-24, 1397/08/02
Update count:0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Maryam Mehdizadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 945 4770
Email address
maryam.mehdizadeh_22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical activity on cognition, vision and motor function in people with Parkinson disease and its animal model
Public title
The effect of physical activity on people with Parkinson disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People diagnosed with Parkinson's Disease
Ability to walk independently for a distance of at least 10 meters with and without asistive devices
Ability to perform the hardest level of laboratory tests
Have a Mini Mental State Examination score equal or more than 21
Exclusion criteria:
Having another disease before entering the study
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, people with Parkinson's disease will be selected as available, and then randomly assigned into two groups randomly without any blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be triple-blind study. In this study, patients, therapist and data analyst will not be aware of the type of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
ran University of Medical Sciences, Shahid Hemmat Highway, Tehran,1449614535,IRAN.
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2018-09-25, 1397/07/03
Ethics committee reference number
IR.IUMS.REC.1397.216
Health conditions studied
1
Description of health condition studied
Parkinson's Disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Postural control (Balance improvement after treatment)
Timepoint
Before and after intervention
Method of measurement
force plate in bio-mechanic lab
Secondary outcomes
1
Description
Cognitive function based on changes in BDNF protein
Timepoint
Before and After intervention
Method of measurement
Study of serum BDNF levels by analyzing blood samples
Intervention groups
1
Description
Parkinson's disease (PD) is one of the most common progressive neurodegenerative disorders. Physical exercise takes into account an important protective approach to prevent abnormal function and cell death in the brain. Beneficial effects including molecular changes in the brain to increase memory and learning might reduce apoptosis in Retinal cells. Therefore, it is important to seek more effective therapeutic interventions as well as low-cost ones for PD. In this study, the mechanism of its effect in PD and its animal model will be considered.
Category
Rehabilitation
2
Description
Control group: In this study, the control group will not receive any specific training.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Rasool General Hospital
Full name of responsible person
Maryam Mehdizadeh
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,1449614535,IRAN.
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8843 3583
Email
Maryam.mehdizadeh_22@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,1449614535,IRAN.
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mehdizadeh
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,1449614535,IRAN.
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8843 3583
Email
maryam.mehdizadeh_22@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mehdizadeh
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,1449614535,IRAN.
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8843 3583
Email
maryam.mehdizadeh_22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Mehdizadeh
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,1449614535,IRAN
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8843 3583
Email
maryam.mehdizadeh_22@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
NO
From where data/document is obtainable
email addresses
What processes are involved for a request to access data/document