UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039497 |
|---|---|
| Receipt number | R000045038 |
| 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 |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/08/24 09:52:41 |
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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
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
19mr03@g.seirei.ac.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045038
