UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028865 |
|---|---|
| Receipt number | R000033020 |
| Scientific Title | The effect of neuromuscular electrical stimulation in patients with thoracic aortic surgery: a non-randomized controlled trial |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2022/02/03 14:31:38 |
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Basic information
Public title
The effect of neuromuscular electrical stimulation in patients with thoracic aortic surgery: a non-randomized controlled trial
Acronym
The effect of neuromuscular electrical stimulation in patients with thoracic aortic surgery
Scientific Title
The effect of neuromuscular electrical stimulation in patients with thoracic aortic surgery: a non-randomized controlled trial
Scientific Title:Acronym
The effect of neuromuscular electrical stimulation in patients with thoracic aortic surgery
Region
| Japan |
Condition
Condition
Thoracic aortic surgery
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of neuromuscular electrical stimulation in patients with thoracic aortic surgery by a non-randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main outcome is preoperative and postoperative day 14 quadriceps muscle strength.
Key secondary outcomes
Secondary outcome is grip strength, gait speed, modified-functional reach test those are mearusured at preoperative and postoperative day 14, and length of icu stay, length of hospital stay.
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
| Device,equipment |
Interventions/Control_1
Muscle strength training with neuromuscular electrical stimulation is performed for 30-min to 60-min each day, 5-days per week, from the postoperative day 1 to day 14. Neuromuscular electrical stimulation is performed at the vastus lateralis, vastus medialis, and triceps surae. The intensity levels are aimed to cause visible and/or palpable contractions and be minimum if patients are sedation, and aimed to cause visible and/or palpable contractions and be tolerated by the patients if they are awake.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are 65 years old and above, postoperative ventilation time 24 hours and above, preoperative muscle strength test of those are consecutive elective thoracic aortic operation.
Key exclusion criteria
Patients who are postoperative stroke or spinal cord injury, postoperative ventilation time 168 hours and above, preoperative cognitive dysfunction.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Rehabilitation Science
Zip code
461-8673
Address
1-20 Daiko Minami, Higashi-ku, Nagoya
TEL
052-719-1346
yamadas@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Shimizu |
Organization
Nagoya University Hospital
Division name
Department of Rehabilitation
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-741-2111
Homepage URL
miho.shimizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Bioethics advisory council, Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-741-2111
ethics@med.nagoya-u.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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 03 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033020
