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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039369
Receipt No. 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 2020/02/03

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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
Email 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
Email mhe1808@std.huhs.ac.jp

Sponsor
Institute Meiwa General Hospital
Institute
Department

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
Email 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 Open public recruiting
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 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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