UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of exercise therapy on functioning in patients with early stage amyotrophic lateral sclerosis, Multicenter collaborative study
Title of the study (Brief title)	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	Kosuke Kitano
Organization	Murakami Karindoh Hospital
Division name	Department of Rehabilitation
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	Kosuke Kitano
Organization	Murakami Karindoh Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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