UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048532 |
|---|---|
| Receipt number | R000055229 |
| Scientific Title | Short-term effects of neuromuscular electrical stimulation therapy in elderly inpatients |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/08/01 09:04:43 |
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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
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
ayuna.s2laaav@gmail.com
Sponsor or person
Institute
The Open University of Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055229
