UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056383 |
|---|---|
| Receipt number | R000064420 |
| Scientific Title | Effect of standing exercise combined with local vibration stimuli on hypertrophy for disused triceps surae muscle in older adults |
| Date of disclosure of the study information | 2024/12/07 |
| Last modified on | 2024/12/06 20:28:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of standing exercise combined with local vibration stimuli on hypertrophy for disused triceps surae muscle in older adults
Acronym
Effect of standing exercise combined with vibration stimuli on disused muscle atrophy
Scientific Title
Effect of standing exercise combined with local vibration stimuli on hypertrophy for disused triceps surae muscle in older adults
Scientific Title:Acronym
Effect of standing exercise combined with vibration stimuli on disused muscle atrophy
Region
| Japan |
Condition
Condition
patients with disuse syndrome (patients who met the criteria for intensive care unit-acquired weakness)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether 4 weeks of standing exercise combined with LV increases muscle thickness of disused, atrophied triceps surae and physical functions compared to standing without LV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle thickness of the lower leg, range of motion (ROM) of ankle dorsiflexion, maximum isometric strength of the plantar flexor, muscle activity of the medial gastrocnemius, skeletal muscle index, motor functional independence measure (FIM) score, activities of daily living assessment, and functional mobility.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
the intervention consisted of five sets of 30-second standing exercises per day, 5 days/week, for 4 weeks while grasping support, and a massager was wrapped around the gastrocnemius muscles of both lower legs, allowing a 57 Hz oscillator to target the abdomen while participants maintained a standing position (group with concomitant Local Vibration ;LV group).
Interventions/Control_2
the intervention consisted of five sets of 30-second standing exercises per day, 5 days/week, for 4 weeks while grasping support (standing-only group,; NV group).
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
| 105 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among the patients admitted to the community integrated care ward, 24 patients who met the criteria for intensive care unit-acquired weakness were defined as having disuse syndrome.
Key exclusion criteria
Patients who can stand independently
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Mahiro |
| Middle name | |
| Last name | Murakami |
Organization
Graduate School, Seijoh University,
Division name
Department of Health Care Studies
Zip code
4768588
Address
2-172 Fukinodai, Toukai-City, Aichi 476-8588, Japan
TEL
0526016000
mahiro.murakami93@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ochi |
Organization
Graduate School, Seijoh University,
Division name
Department of Health Care Studies
Zip code
4768588
Address
2-172 Fukinodai, Toukai-City, Aichi 476-8588, Japan
TEL
0526016000
Homepage URL
ochi@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seijoh University
Address
2-172 Fukinodai, Toukai-City, Aichi 476-8588, Japan
Tel
0526016000
mahiro.murakami93@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 07 | 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
24
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064420
