UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047315 |
|---|---|
| Receipt number | R000053922 |
| Scientific Title | A single arm feasibility study of video-based resistance training in elderly patients with lung cancer undergoing surgery. |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2022/06/20 12:38:28 |
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Basic information
Public title
A single arm feasibility study of video-based resistance training in elderly patients with lung cancer undergoing surgery.
Acronym
A single arm feasibility study of video-based resistance training in elderly patients with lung cancer undergoing surgery.
Scientific Title
A single arm feasibility study of video-based resistance training in elderly patients with lung cancer undergoing surgery.
Scientific Title:Acronym
A single arm feasibility study of video-based resistance training in elderly patients with lung cancer undergoing surgery.
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the implementation rate and feasibility of video-based resistance training in elderly patients with lung cancer undergoing surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The percentage of patients are able to watch videos and exercise resistance training at least 3 times per week for 2 weeks.
Key secondary outcomes
Adverse event rates
Appreciation for resistance training
Questionnaire about training video
Incremental shuttle walking test(ISWT)
Quadriceps muscle strength
Skeletal muscle mass Index(SMI)
The length of postoperative hospital stay
Postoperative complications
Readmission rate
Pulmonary function test
FACT-L
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
Watch the video and perform the exercise at least three times a week, once a day, for 2-4 weeks.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Diagnosed with non-small cell lung cancer or suspected non-small cell lung cancer (on the date of enrollment) and histologically diagnosed as non-small cell lung cancer.
(2)Scheduled for thoracoscopic lobectomy or sectional resection within four weeks.
(3)A waiting period for surgery is at least two weeks.
(4)Aged 75 years or older at the time of obtaining consent (on the date of enrollment).
Key exclusion criteria
(1)Patients with an underlying medical condition that limit resistance training .
Unstable angina, myocardial infarction within a short period of time from onset.
Uncompensated heart failure.
Uncontrolled arrhythmia, diabetes, and hypertension.
Severe pulmonary hypertension, severe corpulmonale , acute pulmonary embolism.
Active acute myocarditis, endocarditis, pericarditis, severe aortic stenosis.
Acute systemic inflammatory diseases.
Severe hepatopathy, severe nephropathy.
Serious orthopedic diseases that limit resistance training.
Other patients judged unsuitable for enrollment in this clinical trial by the physician in charge.
(2)Patients cannot use devices to watch videos at home (DVD players or other devices connected to Internet to watch YouTube).
(3)Patients cannot read, write, or understand Japanese.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | nobuko |
| Middle name | |
| Last name | konishi |
Organization
National cancer center East hospital
Division name
Department of Rehabilitation
Zip code
277-8577
Address
6-5-1 kashiwanoha, kasiwashi, chiba City
TEL
04-7133-1111
nokonish@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | nobuko |
| Middle name | |
| Last name | konishi |
Organization
National cancer center East hospital
Division name
Department of Rehabilitation
Zip code
277-8577
Address
6-5-1 kashiwanoha, kasiwashi, chiba City
TEL
04-7133-1111
Homepage URL
nokonish@east.ncc.go.jp
Sponsor or person
Institute
National cancer center East hospital
Institute
Department
Personal name
Funding Source
Organization
The Japan Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center East hospital
Address
5-1-1 Tsukiji, Tyuuouku, Tokyo City
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2022 | Year | 04 | Month | 06 | 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
| 2022 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 03 | Month | 29 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053922
