UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043923
Receipt number R000050069
Scientific Title Effect of home exercise therapy before and after liver resection in elderly: Randomized controlled trial
Date of disclosure of the study information 2021/04/15
Last modified on 2021/10/14 10:00:42

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Basic information

Public title

Effect of home exercise therapy before and after liver resection in elderly: Randomized controlled trial

Acronym

Effect of home exercise therapy before and after liver resection in elderly: Randomized controlled trial

Scientific Title

Effect of home exercise therapy before and after liver resection in elderly: Randomized controlled trial

Scientific Title:Acronym

Effect of home exercise therapy before and after liver resection in elderly: Randomized controlled trial

Region

Japan


Condition

Condition

Independently living elderly (age of 65 years or older) who plan to undergo liver resection

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This is the randomized controlled trials that induction of home exercise therapy 1 month before surgery and 3 months after discharge can decrease incidence of postoperative loss of independence after liver resection. This is a pilot study.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of loss of independence 3 months after discharge

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Home exercise therapy (1 month before surgery and 3 months after discharge)

Interventions/Control_2

Normal life

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Planning to undergo liver resection
age of 65 years or older
Living independent

Key exclusion criteria

Age <65 years
Concomitant biliary reconstruction and resection of other organs except gallbladder
Need any healthcare supports before surgery
Pulse <40/min or >120/min
Systolic blood pressure <70mmHg or >200mmHg
Diastolic blood pressure >120mmHg
Angina pectoris of effort
Atrial fibrillation
Myocardial infarction within 3 months
Severe arrhythmia
Chest pain even at rest
Palpitation and breathlessness before exercise
Dissiness, cold sweat, and nausea on sitting
Body temperature >38 degree
Uncontrollable asthma

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Shogo
Middle name
Last name Tanaka

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Hepato-Biliary-Pancreatic Surgery

Zip code

545-8585

Address

1-4-3 Asahimachi, Abeno-ku, Osaka

TEL

0666453841

Email

m8827074@msic.med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Shogo
Middle name
Last name Tanaka

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Hepato-Biliary-Pancreatic Surgery

Zip code

545-8585

Address

1-4-3 Asahimachi, Abeno-ku, Osaka

TEL

0666453841

Homepage URL


Email

m8827074@msic.med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

Osaka City University Graduate School of Medicine

Address

1-4-3 Asahimachi, Abeno-ku, Osaka

Tel

0666453841

Email

m8827074@msic.med.osaka-cu.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

大阪市立大学医学部附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 15 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

Enrolling by invitation

Date of protocol fixation

2021 Year 01 Month 15 Day

Date of IRB

2021 Year 04 Month 05 Day

Anticipated trial start date

2021 Year 05 Month 15 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

Patients who will undergo surgery until March 2022 are included.


Management information

Registered date

2021 Year 04 Month 14 Day

Last modified on

2021 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050069


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name