UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044878