UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033787
Receipt No. R000038526
Scientific Title Effectiveness of interventions based on `HAPA theory' hospitalized to discharged to home maintain and improve the physical activity : A Randomized Controlled, Double-blind, Parallel-group Trial
Date of disclosure of the study information 2018/08/16
Last modified on 2019/08/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effectiveness of interventions based on `HAPA theory' hospitalized to discharged to home maintain and improve the physical activity : A Randomized Controlled, Double-blind, Parallel-group Trial
Acronym Effectiveness of interventions based on `HAPA theory' aimed at maintaining and improving physical activity
Scientific Title Effectiveness of interventions based on `HAPA theory' hospitalized to discharged to home maintain and improve the physical activity : A Randomized Controlled, Double-blind, Parallel-group Trial
Scientific Title:Acronym Effectiveness of interventions based on `HAPA theory' aimed at maintaining and improving physical activity
Region
Japan

Condition
Condition Patients who can walk independently and aged 65 years or older with discharged from convalescent rehabilitation units to home.
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation on intervention effect based on `HAPA theory' during hospitalization aiming to maintain and improve the amount of physical activity after discharged
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Physical activity(After discharge,2 weeks to 6 months)
Key secondary outcomes Physical function:10m Walk test,Timed up and Go test,6-Minute Walk Distance,Method of the indoor walk,Method of the outdoor walk,Outdoor walking degree of autonomy
Cognitive function:The Rapid Dementia Screening Test (RDST)
Psychological function:Quality Of Life(EQ-5D-5L),Geriatric Depression Scale(GDS),Fall Efficacy(FES),Self-Efficacy
Range of activity space:Life-Space Assessment(LSA)
Environmental factors:Abbreviated Neighborhood Environment Walkability Scale(ANEWS)
Experience of falling

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Providing standard rehabilitation (physical therapy, occupational therapy, speech hearing therapy, a total of 120 to 160 minutes, seven times a week) and monitored physical activity using a table by self-description for one month from the time when walking became independent.
Every week, the responsible therapist will prepare a behavior / coping plan concerning the physical activity using the booklet (during hospitalization and after discharge).
We will conduct feedback based on the state of implementation of the physical activity of last week.
Interventions/Control_2 Providing standard rehabilitation (physical therapy, occupational therapy, speech hearing therapy, total 120 to 160 minutes, seven times a week) and provide information by a brochure on exercise (devised by the Ministry of Health, Labor and Welfare) aimed at main taining and enhancing mobility.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients aged 65 years or older who can walk.
Key exclusion criteria 1.Patients who are difficult to discharge from home at discharge.
2.Patients with marked cognitive and mental function decline (RDST less than 7).
3.Patients with aphasia to the extent that interferes with telephone surveillance.
4.Patient with doctor's exercise restriction order.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Itushi
Middle name
Last name Takai
Organization Osaka University of Economics
Division name Department of Human Sciences
Zip code 533-8533
Address 2-2-8,Osumi,Higashiyodogawa-ku,Osaka
TEL 06-6328-2431
Email takai@osaka-ue.ac.jp

Public contact
Name of contact person
1st name Yuuri
Middle name
Last name Masuda
Organization Kyouwakai Medical Corporation Senrichuo Hospital
Division name rehabilitation unit
Zip code 560-0082
Address 1-4-3,Shinsenri-higashi-machi,Toyonaka-shi, Osaka
TEL 06-6834-1100
Homepage URL
Email cyclefreak1031@gmail.com

Sponsor
Institute Kyouwakai Medical Corporation Senrichuo 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) Ministry of Education, Culture, Sports, Science and Technology

IRB Contact (For public release)
Organization Osaka University of Economics
Address 2-2-8,Osumi,Higashiyodogawa-ku,Osaka,533-8533
Tel 0663282431
Email takai@osaka-ue.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 千里中央病院(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 16 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 35
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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 15 Day
Date of IRB
2018 Year 08 Month 15 Day
Anticipated trial start date
2018 Year 08 Month 27 Day
Last follow-up date
2020 Year 01 Month 12 Day
Date of closure to data entry
2020 Year 01 Month 17 Day
Date trial data considered complete
2020 Year 01 Month 20 Day
Date analysis concluded
2020 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 16 Day
Last modified on
2019 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.