UMIN-CTR Clinical Trial

Basic information
Public title	The effect of physical activity counseling for patients with during and after hospitalization for an exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial
Acronym	The effect of physical activity counseling for patients with during and after hospitalization for an exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial
Scientific Title	The effect of physical activity counseling for patients with during and after hospitalization for an exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial
Scientific Title:Acronym	The effect of physical activity counseling for patients with during and after hospitalization for an exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify the effect of physical activity counseling starting during hospitalization on physical activity 1 month after discharge
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical activity at 1 month after discharge
Key secondary outcomes	six minutes walk test, quadriceps strength, COPD assessment test, mMRC dyspnea scale, General self efficacy scale at 1 month after discharge, readmission rate at 1 year after discharge

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Conduct physical activity counseling including motivation, goal setting, and feedback four times during hospitalization
Interventions/Control_2	Continue physical activity counseling by telephone once a week until one month after discharge
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Patients diagnosed with acute exacerbation by a respiratory physician and hospitalized 2 Independent walking (FIM 6 or more) 3 MMSE score of 24 or higher 4 Those who lived at home before hospitalization
Key exclusion criteria	1 Those who have been hospitalized due to acute exacerbation within the past 30 days 2 Those who suffered from a neurological or musculoskeletal disease that would prevent them from being active 3 Patients who have been hospitalized for less than 7 days or more than 30 days 4 Those who were discharged to hospital or nursing home
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Daiki Middle name Last name Kato
Organization	Seirei Hamamatsu General Hospital
Division name	Department of rehabilitation
Zip code	430-8558
Address	2-12-12 Sumiyoshi, Naka Ward, Hamamatsu, Shizuoka 430-8558
TEL	053-474-2222
Email	19mr03@g.seirei.ac.jp

Public contact
Name of contact person	1st name Daiki Middle name Last name Kato
Organization	Seirei Hamamatsu General Hospital
Division name	Department of rehabilitation
Zip code	430-8558
Address	2-12-12 Sumiyoshi, Naka Ward, Hamamatsu, Shizuoka 430-8558
TEL	053-474-2222
Homepage URL
Email	19mr03@g.seirei.ac.jp

Sponsor
Institute	Seirei Hamamatsu General Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Seirei Hamamatsu General Hospital
Address	2-12-12 Sumiyoshi, Naka Ward, Hamamatsu, Shizuoka 430-8558
Tel	053-474-2222
Email	19mr03@g.seirei.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	聖隷浜松病院（静岡県）

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 01 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	2020 Year 02 Month 12 Day
Date of IRB	2020 Year 02 Month 26 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2023 Year 04 Month 01 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 16 Day
Last modified on	2020 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045038