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Trial details
Trial details
Effect of cycle ergometer training on balance and cognition in moderate to severely demented elderly, a Randomized Clinical Trial
Current status:
Approved
|
Date registered:
29/01/2020
|
Date last updated:
29/01/2020
Trial version(s)
Current: 27/01/2020
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Main Information
Primary registry identifying number
LBCTR2020012391
Protocol number
LBCTR2020012391
MOH registration number
NA
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
We thought that IRB approval (2018) was enough to start recruiting, especially that the intervention is not invasive. Additionally, the subjects are either treated by random exercises or not treated by exercise
Date of registration in national regulatory agency
Primary sponsor
Centre National de Recherche Scientifique (CNRS) Lebanon
Primary sponsor: Country of origin
Lebanon
Public title
Effect of cycle ergometer training on balance and cognition in moderate to severely demented elderly, a Randomized Clinical Trial
Acronym
NA
Scientific title
Effect of cycle ergometer training on balance and cognition in moderate to severely demented elderly, a Randomized Clinical Trial
Acronym
NA
Brief summary of the study: English
Studies on demented populations worldwide have dramatically increased in the last decades. Demented people present with a set of symptoms that may include memory loss and difficulties with thinking, problem solving or language, as well as change in mood and behavior. Physical activity was proved to be the most successful key factors in preserving mental and physical health among elderly persons. Nowadays, physical therapists and health professionals are seeking passive exercise tool that can provide the demented elderly the needed amount of daily physical activity despite the cognitive impairment they are suffering from. One of those passive exercise tool is the motorized cycle ergometer (MCE), which is a motorized bicycle that can be run on passive mode. Therefore, we will investigate the effectiveness of cycle ergometer as a method of exercise for elderly persons with moderate to severe dementia.
Brief summary of the study: Arabic
ان الدراسات على كبار السن وخاصة اولئك الذین یعانون من الخرف قاد زادت بشكل ملحوظ. قد لقد تم اثبات ان النشاط البدني ھو من اھم الاستراتیجیات العلاجیة والتي برھنت فعالیة بالحفاظ على الصحة الجسدیة والعقلیة لدى المسنین. ان من اھم المشاكل المصاحبة لكبار السن، خاصة المصابین بالخرف، ھي صعوبات التفكیر، الذاكرة، بالإضافة الى الى التغیرات السلوكیة والمزاجیة. حالیا،ً یقوم المعالجین الفیزیائیین والعاملین بالقطاع الصحي بمحاولات للتغلب على ھذه الصعوبات عبر ادراج ھذه المجموعة من المرضى ضمن برامج ریاضیة تدریبیة لا تتطلب مستوى مشاركة فكریة من قبل المریض. احدى ھذه الطرق قد تكون الدراجة الثابتة المزودة بمحرك احدى ھذه الطرق العلاجیة. ان ھذه الدراسة تھدف الى معرفة تأثیر التریب بالدراجة الثابتة المزودة بمحرك على التوازن والقدرات المعرفیة عند المسنین المصابین بالخرف المتوسط او الشدید.
Health conditions/problem studied: Specify
Geriatric Moderate to severe dementia
Interventions: Specify
exercise program motorized cycle ergometer
Key inclusion and exclusion criteria: Inclusion criteria
• Inclusion criteria: Subjects should be above the age of 65 They should be diagnosed with moderate to severe dementia They should not have any other severe orthopedic or neurological conditions like stroke, Parkinson, or hip fracture They should be ambulating independently with or without the need for a gait assistance device (walker or crutches...)
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
65
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion criteria: Patients previously suffering or still suffering from severe neurological condition Any orthopedic surgery on the lower limbs in the last 12 months prior the recruitment in this study Subjects that were diagnosed with mild dementia or mild cognitive impairment Subjects that are below the age of 65.
Type of Study
Type
Interventional
Type of intervention
Rehabilitation strategies
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
N/A
Study design: Purpose
Treatment
Study design: Assignment
Parallel
Pharmaceutical class
NA
Therapeutic indication
NA
Therapeutic benefit
NA
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
60
Actual enrollment target size
60
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
03/01/2019
Date of study closure: Type
Anticipated
Date of study closure: Date
31/01/2020
Recruitment status
Complete
Date of completion
31/03/2020
IPD sharing statement plan
No
IPD sharing statement description
NA
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Beirut Arab University
2018H-0043-HS-R-0270
Sources of Monetary or Material Support
Name
Beirut Arab University
Centre National de Recherche Scientifique (CNRS) Lebanon
Secondary Sponsors
Name
Dar Al Ajaza Al Islamiah Hospital
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
rami
Abbas
Beirut
Lebanon
009613942067
r.abbas@bau.edu.lb
BAU
Scientific
Ibtissam
Saab
Beirut
Lebanon
009613959040
ibtissam.saab@bau.edu.lb
BAU
Scientific
Ayman
El Khatib
Beirut
Lebanon
0096171587317
a.elkhatib@bau.edu.lb
BAU
Scientific
Hassan
El Charif
Beirut
Lebanon
009613819772
hassanne@gmail.com
Dar Al Ajaza Isalamiah Hospital
Scientific
Nabil
Naja
Beirut
Lebanon
009613725449
nabilbnaja@gmail.com
Dar Al Ajaza Isalamiah Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Dar Al Ajaza Al Islamiah Hospital
Rami Abbas
Physical Therapy
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Beirut Arab University
22/03/2018
Dr. Issam Othman
irb@bau.edu.lb
00961376695224
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
dementia
Dementia in other diseases classified elsewhere (F02)
Dementia
Interventions
Intervention
Description
Keyword
exercise
regular exercise program
Ex
motorized cycle ergometer
motorized cycle ergometer
Mo
Primary Outcomes
Name
Time points
Measure
Cognition
Before and after 12 weeks of intervention
Mini Mental State Exam
Balance
Before and after 12 weeks of intervention
Berg Balance Scale
Gait
Before and after 12 weeks of intervention
Timed up and Go test
Key Secondary Outcomes
Name
Time points
Measure
Gait
before and after 12 weeks
Timed up and go test
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial