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
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
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
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
