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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028103
Receipt No. R000032173
Scientific Title The effect of exercise therapy on functioning in patients with early stage amyotrophic lateral sclerosis, Multicenter collaborative study
Date of disclosure of the study information 2017/07/06
Last modified on 2017/07/06

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Basic information
Public title The effect of exercise therapy on functioning in patients with early stage amyotrophic lateral sclerosis, Multicenter collaborative study
Acronym The effect of exercise therapy on functioning in patients with early stage amyotrophic lateral sclerosis, Multicenter collaborative study
Scientific Title The effect of exercise therapy on functioning in patients with early stage amyotrophic lateral sclerosis, Multicenter collaborative study
Scientific Title:Acronym The effect of exercise therapy on functioning in patients with early stage amyotrophic lateral sclerosis, Multicenter collaborative study
Region
Japan

Condition
Condition amyotrophic lateral sclerosis
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This prospective, multicenter, collaborative study, we investigate the effects of home-based exercises in patients with early-stage ALS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ALS Functional Rating Scale-Revised
Key secondary outcomes 40-item ALS Assessment Questionnaire
Cough Peak Flow
Manual Muscle Testing
5-meter walking time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Physical therapy and home based exercise
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ALS patients, judged by experienced neurologists
ALSFRS-R is 30 points or more
Frontal Assessment Battery is 13 points or more
Key exclusion criteria No neuromuscular disease other than ALS
No heart disease such as myocardial infarction or cardiac insufficiency
No respiratory disease such as chronic obstructive pulmonary disease
No malignant tumors
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosuke Kitano
Organization Murakami Karindoh Hospital
Division name Department of Rehabilitation
Zip code
Address 2-14-45 Togire, Nishi-ku, Fukuoka, Fukuoka
TEL 092-811-3331
Email kitano.k@karindoh.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Kitano
Organization Murakami Karindoh Hospital
Division name Department of Rehabilitation
Zip code
Address 2-14-45 Togire, Nishi-ku, Fukuoka, Fukuoka
TEL 092-811-3331
Homepage URL
Email kitano.k@karindoh.or.jp

Sponsor
Institute Murakami Karindoh Hospital
Institute
Department

Funding Source
Organization Yuumi Memorial Foundation for Home Health Care
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 村上華林堂病院(福岡)、吉野内科・神経内科医院(千葉)、北里大学医療衛生学部(神奈川)、国立精神神経医療研究センター病院(東京都)、公立八鹿病院(兵庫県)、美原記念病院(群馬)、鳥取医療センター(鳥取)、箱根病院(神奈川)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Home-based exercises for patients with early-stage ALS could be used to alleviate functional deterioration.
Home-based exercise for patients with early-stage ALS could be safely and continuously performed by physical therapists.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2017 Year 02 Month 28 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032173

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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