UMIN-CTR Clinical Trial

Basic information
Public title	Short-term effects of neuromuscular electrical stimulation therapy in elderly inpatients
Acronym	Short-term effects of neuromuscular electrical stimulation therapy in elderly inpatients
Scientific Title	Short-term effects of neuromuscular electrical stimulation therapy in elderly inpatients
Scientific Title:Acronym	Short-term effects of neuromuscular electrical stimulation therapy in elderly inpatients
Region	Japan

Condition
Condition	Disuse syndrome
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess whether the combination of NMES and exercise therapy can prevent disuse muscle atrophy and muscle weakness in the early stages of bed rest in elderly inpatients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle thickness of the rectus femoris and gastrocnemius muscles as measured by ultrasound imaging equipment before and after the intervention (7 days).
Key secondary outcomes	Strength and brightness of rectus femoris and gastrocnemius muscles, circumference of thigh and lower legs, grip strength on both sides, age, height, and weight before and after the intervention period (7 days).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The intervention group receives 20 minutes of exercise therapy and 60 minutes of NMES (Intelect Mobile Stim, Chattanooga) daily in bed. Stimulation electrodes are attached to the bilateral motor points of the rectus femoris and gastrocnemius muscles, and the patients are instructed to perform voluntary contractions in response to the stimulation during the NMES. The intervention period will be 7 days and the following outcome measures will be measured before and after the intervention period.
Interventions/Control_2	The control group receives 80 minutes of exercise therapy daily in bed. The intervention period will be 7 days and the following outcome measures will be measured before and after the intervention period.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	- Female inpatients 65 years of age or older - Able to hold a standing position prior to admission - Grip strength of at least 18 kg at the time of admission - Expected to require a period of bed rest for 7 days after admission
Key exclusion criteria	- Orthopedic surgery on the lower extremities - Have a history of cerebrovascular disease - Diseases are known to accelerate skeletal muscle mass loss (end-stage cancer, congestive heart failure, severe chronic obstructive pulmonary disease) - Contraindications to NMES (malignant tumor, bleeding, skin damage, etc. at the stimulation site)
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ayuna Middle name Last name Hasegawa
Organization	The Open university of Japan
Division name	Graduate School of Arts and Sciences, Human Life and Health Sciences
Zip code	261-8586
Address	2-11 Wakaba, Mihama-ku, Chiba-shi, Chiba
TEL	043-276-5111
Email	ayuna.s2laaav@gmail.com

Public contact
Name of contact person	1st name Ayuna Middle name Last name Hasegawa
Organization	The Open University of Japan
Division name	Graduate School of Arts and Sciences, Human Life and Health Sciences
Zip code	261-8586
Address	2-11 Wakaba, Mihama-ku, Chiba-shi, Chiba
TEL	090-3613-4460
Homepage URL
Email	ayuna.s2laaav@gmail.com

Sponsor
Institute	The Open University of Japan
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Open University of Japan Graduate School
Address	2-11 Wakaba, Mihama-ku, Chiba-shi, Chiba
Tel	0432765111
Email	rinrishinsa@ouj.ac.jp

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	高田上谷病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	Open public recruiting
Date of protocol fixation	2022 Year 06 Month 10 Day
Date of IRB	2022 Year 06 Month 03 Day
Anticipated trial start date	2022 Year 06 Month 13 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 01 Day
Last modified on	2022 Year 08 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055229

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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