UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039369 |
|---|---|
| Receipt number | R000044878 |
| Scientific Title | The effectiveness of physical activity enhancement intervention using accelerometer in patients undergoing lung resection.-a randomized controlled traial- |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2020/11/09 16:43:17 |
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Basic information
Public title
Effects of physical activity enhancement intervention using accelerometer in patients undergoing lung resection.
Acronym
Effects of physical activity enhancement intervention in patients undergoing lung resection.
Scientific Title
The effectiveness of physical activity enhancement intervention using accelerometer in patients undergoing lung resection.-a randomized controlled traial-
Scientific Title:Acronym
The effectiveness of physical activity enhancement intervention using accelerometer in patients undergoing lung resection.-a randomized controlled traial-
Region
| Japan |
Condition
Condition
primary lung cancer and metastatic lung tumors.
Classification by specialty
| Chest surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of exercise instruction using accelerometer on physical activity of patients undergoing lung resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity two months after surgery
Key secondary outcomes
Physical function
Cancer-related symptoms
Health-related quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
Postoperative rehabilitation during hospitalization
exercise instruction using accelerometer on physical activity
Interventions/Control_2
Controll group
Postoperative rehabilitation during hospitalization only
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing lung resection
patients who have completed the preoperative evaluation with a waiting period of at least one week
Key exclusion criteria
patients refusal to participate in the study
patients who could not complete the set evaluation
patients who have restricted motor function
patients who suspected cognitive decline
Patients who diagnosed with non-neoplastic lung tumor
patients who are judged that physical activity enhancement is not desirable by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Sunahara |
Organization
Meiwa General Hospital
Division name
Department of Rehabilitaiton
Zip code
663-8186
Address
4-31, Agenaruo-cho, Nishinomiya-shi, Hyogo
TEL
0798-47-1767
mhe1808@std.huhs.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Sunahara |
Organization
Meiwa General Hospital
Division name
Department of Rehabilitation
Zip code
663-8186
Address
4-31, Agenaruo-cho, Nishinomiya-shi, Hyogo
TEL
0798-47-1767
Homepage URL
mhe1808@std.huhs.ac.jp
Sponsor or person
Institute
Meiwa General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiwa General Hospital
Address
4-31, Agenaruo-cho, Nishinomiya-shi, Hyogo
Tel
0798-47-1767
mhe1808@std.huhs.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
| 2020 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
