UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056821 |
|---|---|
| Receipt number | R000062356 |
| Scientific Title | Effects of Short-Term, Low-Intensity Exercise Instruction on Physical Activity in Patients With Advanced Lung Cancer -A Randomized Controlled Trial- |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2025/01/26 16:33:04 |
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Basic information
Public title
Effects of short-term, low-intensity exercise guidance on physical activity in patients with advanced lung cancer
Acronym
Effects of short-term, low-intensity exercise guidance on physical activity in patients with advanced lung cancer
Scientific Title
Effects of Short-Term, Low-Intensity Exercise Instruction on Physical Activity in Patients With Advanced Lung Cancer -A Randomized Controlled Trial-
Scientific Title:Acronym
Effects of Short-Term, Low-Intensity Exercise Instruction on Physical Activity in Patients With Advanced Lung Cancer -A Randomized Controlled Trial-
Region
| Japan |
Condition
Condition
Advanced lung cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effects of low-intensity, short-duration exercise guidance during hospitalization on physical activity, self-efficacy, and motor function after discharge from the hospital for patients with advanced lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of physical activity.
Self-efficacy scale for advanced cancer.
The European Organization for Research and Treatment of Cancer.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
3 times at the time of hospitalization, discharge, and readmission
Interventions/Control_2
With or without intervention
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
| 40 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stage 3~4 lung cancer patients undergoing chemotherapy
Patients with a PS of 2~3 who are able to walk independently
Patients who have received more than 2 courses of similar chemotherapy in hospital
Key exclusion criteria
Patients suspected of impaired consciousness or delirium
Patients with difficulty walking
Patients with cognitive function
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | junichi |
| Middle name | |
| Last name | yabuuchi |
Organization
Fukuchiyama City Hospital
Division name
Department of Rehabilitation
Zip code
6200056
Address
231 Atsunaka-cho, Fukuchiyama-shi, Kyoto
TEL
0773222101
saitoutakashi0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | yabuuchi |
Organization
Fukuchiyama City Hospital
Division name
Department of Rehabilitation
Zip code
6200056
Address
231 Atsunaka-cho, Fukuchiyama-shi, Kyoto
TEL
0773222101
Homepage URL
saitoutakashi0214@yahoo.co.jp
Sponsor or person
Institute
Fukuchiyama City Hospital
Institute
Department
Personal name
Department of Rehabilitation
Funding Source
Organization
Fukuchiyama City Hospital
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
Fukuchiyama City Hospital
Address
231 Atsunaka-cho, Fukuchiyama-shi, Kyoto
Tel
0773222101
saitoutakashi0214@yahoo.co.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 | 01 | Month | 27 | 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
40
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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 20 | 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 | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062356
