UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058730 |
|---|---|
| Receipt number | R000067156 |
| Scientific Title | A study to examine the safety and tolerability of a home-based exercise program after local therapy for liver cancer |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 01:42:07 |
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Basic information
Public title
A study to examine the safety and tolerability of a home-based exercise program after local therapy for liver cancer
Acronym
Home-based Exercise for Adjuvant recovery after Liver cancer therapy
Scientific Title
A study to examine the safety and tolerability of a home-based exercise program after local therapy for liver cancer
Scientific Title:Acronym
Home-based Exercise for Adjuvant recovery after Liver cancer therapy
Region
| Japan |
Condition
Condition
Patients with liver cancer who underwent local therapy, aged 18 years or older, with a performance status (PS) of 0 or 1
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerability, safety, and preliminary efficacy of a home-based exercise program in patients discharged after local therapy for liver cancer in a prospective study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of weeks during the 12-week intervention period in which participants performed strength training at least 3 days per week and achieved the step count target on at least 5 days per week
Key secondary outcomes
Number of feasibility-limiting events during the 12-week intervention period
Reasons for withdrawal or dropout (based on a termination survey at the end of the 12-week period)
Completion and collection rate of the exercise diary from discharge to week 12
Changes in vital signs before and after the 12-week intervention
Changes in grip strength and 6-minute walk distance from baseline to week 12
Changes in quality of life assessed by the Chronic Liver Disease Questionnaire (CLDQ) from baseline to week 12
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 12-week home-based exercise program will be provided to patients aged 18 years or older who have been discharged after local therapy for liver cancer. The program includes resistance training using a theraband targeting three lower limb muscle groups (iliopsoas, quadriceps, gluteus medius) at least 3 days per week, and aerobic exercise in the form of walking. The step count target will start at 3,000 steps per day and increase by 1,000 steps every month. A pedometer and smartphone application will be used to monitor and record adherence.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone local therapy for hepatocellular carcinoma (microwave ablation or transarterial chemoembolization)
Written informed consent obtained
Aged 18 to 80 years
Performance status of 0 or 1
Preserved organ function
Able to attend outpatient visits
Key exclusion criteria
Serious systemic infections or fever >= 38 degrees Celsius
Pregnant, possibly pregnant, or breastfeeding women
Psychiatric illness or symptoms interfering with participation
Ongoing systemic steroid therapy
Uncontrolled diabetes (HbA1c >= 8%) or hypertension
Unstable angina or myocardial infarction within 6 months
Interstitial pneumonia, pulmonary fibrosis, severe emphysema, or acute heart failure
History of cerebrovascular disease within 6 months
Any condition deemed inappropriate by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3833
Homepage URL
michiyukikawakami@hotmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine Research Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067156
