This study will be run by cooperation of neurology and sports medicine departments of Rasool akram hospital. Fifty patients with Parkinson Disease in defined condition will be referred from neurology clinic for exercise therapy. At first, all patients with PD will be evaluated with 6 -minute walk test for functional capacity and time up and go test for balance and all of them will fill out the questionnaire of Quality of Life SF. Then they will be divided randomly to two groups of control and intervention. Exercise therapy begin as standard protocol on treadmill in intervention group during 10 weeks and all of them will be evaluated in at the end of exercise therapy, 2- month and 4-month interval by tests and questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062322891N1
Registration date:2015-07-29, 1394/05/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-29, 1394/05/07
Registrant information
Name
Afsaneh Safar Cherati
Name of organization / entity
Rasoul Akram hospital , Iran university of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7424
Email address
safarcherati.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-23, 1395/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effectiveness of short-term exercise therapy on functional capacity, balance and quality of life in patients with parkinson disease
Public title
Effectiveness of exercise therapy on improvement of quality of life in patients with parkinson disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosed with Parkinson's Disease; being on phase (responsiveness to drug); being on moderate phase (UPDRS ).
Exclusion criteria: freezing gait; atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.); have more than 2 risk factor for cardiovascular disease; significant osteoporosis or arthritis; other neurological disease/complications (e.g. myopathy, stroke, brain lesion, MS); history of significant cardiovascular accident or MI.
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical science Ethics committee
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.IUMS.rec.1394.8811215235
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Parkinsonism or Parkinson disease
Primary outcomes
1
Description
Functional Capacity
Timepoint
10 weeks after begining of trial , 2 and 4 month after finishing trial
Method of measurement
6-minute Walk test , SF-8 quality of Life Questionairre
2
Description
Balance
Timepoint
10 weeks from begining of trial , 2 and 4 month after trial
Method of measurement
Up and go test
3
Description
Quality of Life
Timepoint
10weeks after begining of trial , 2 and 4 months after finishing the trial
Method of measurement
8-SF Questionnaire Quality of Life
Secondary outcomes
1
Description
Activity of Daily Life
Timepoint
2 and 4 months after study
Method of measurement
6- minute walk test
Intervention groups
1
Description
intervention name : Exercise Therapy and drug therapy
intervention description : patients with mid phase PD that have been on drug treatment , Levodopa, will be undergone exercise therapy on treadmill 3 times a week with mild to moderate intensity 30 to 50 minutes every seesion for 10 weeks
Category
Other
2
Description
Interventopn name : drug therapy
Control group : patiens wiyh midphase Parkinson disease are on Levodopa treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nerology Clinic in
Full name of responsible person
Dr Amirhassan Habibi
Street address
Rasoul Akram Hospital, Shahrara, Sattar Khan st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Safar Cherati
Street address
Rasoul hospital, Sattaer Khan avenue
City
Tehran
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
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
Iran university of medical sciences
Full name of responsible person
Paria Arfa Fattolahkhani
Position
Medical student
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Sattar Khan avenue
City
Tehran
Postal code
Phone
+98 21 6651 2446
Fax
Email
arfa.paria.1571991@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Safar Cherati
Position
Assistant professor
Other areas of specialty/work
Street address
Rasoul Akram hospital, Sattar Khan avenue
City
Tehran
Postal code
Phone
+98 21 6651 2446
Fax
Email
afsanehsc@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Safar Cherati
Position
Assistant professor
Other areas of specialty/work
Street address
Rasoul Akram hospital, Sattar Khan avenue
City
Tehran
Postal code
Phone
+98 21 6651 2446
Fax
Email
afsanehsc@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)