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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name