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 UMIN000028317
Receipt No. R000032342
Scientific Title Effects of Adachi Rehabilitation Programme (ARP) for older adults with long term care level 1 to 3: a randomised controlled trial
Date of disclosure of the study information 2017/07/21
Last modified on 2019/07/05

* 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 Effects of Adachi Rehabilitation Programme (ARP) for older adults with long term care level 1 to 3: a randomised controlled trial
Acronym Adachi Rehabilitation Programme
Scientific Title Effects of Adachi Rehabilitation Programme (ARP) for older adults with long term care level 1 to 3: a randomised controlled trial
Scientific Title:Acronym Adachi Rehabilitation Programme
Region
Japan

Condition
Condition Older adults with long term care level 1 to 3
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Adachi Rehabilitation Programme (ARP), a community rehabilitation programme to promote participation, is developed and administered to older adults under the care of long term care insurance services. This is a parallel group randomised controlled trial to assess the effects of ARP on activity and body functions against ordinary care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Number of steps
Timed Up and Go
Key secondary outcomes Physical activity (METs hour)
10 Meter Walk Test
Hand grip strength
Barthel Index
Functional Independence Measure
Mini-Mental State Examination
Short Form 8
EuroQOL 5 Dimension 3 L

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 ARP is a community rehabilitation programme with once a week participation and four week as a cycle. In the first week, the participants take a bus for 10 to 20 minutes to go shopping. The total duration is approximately 3 hours. In the following three weeks, they visit a nearby park to clean the park and plant flowers for one hour once a week.
The park is located in the vicinity (less than 500 meters from the facility), with an area of approximately 1,000 m2 and undulation. The participants walk with or without a stick or rollator. To clean the park, some paricipants use a tong and others hold a bin liner and walk around the park freely. To plant flowers, the participants dig the ground, plant flowers and water them with a water hose.

ARP is conducted for three cycles (12 weeks). The participants spend freely the rest of the time.
Interventions/Control_2 The participants choose one activity from watching television, colouring books or folding lanudry.
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) Long Term Care Level 1 to 3

(2) Not participating in any form of regular aerobic exercise or strength training;

(3) Signed informed consent after explanation

(4) Age: 65 years old or older

(5) Sex: male and female

(6) Live in community and under the care of a Small Multifunctional At-home Care in Adachi-ku, Tokyo
Key exclusion criteria (Exclusion for safety purpose)

(1) Severe neuromuscular diseas, cerebrovascular disease and/or motor diorder

(2) Diagnosed active serious illness or conditions that would contraindicate weight training, such as cancer and myocardial infarct

(3) Exercise is forbidden for medical reason

(Exclusion for risk/benefit balance)

(1) Severe dementia and/or other cognitive impairment judged to interfere with following instructions for assessments or exercise

(2) Unable to use accelerometer
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Kohzuki
Organization Tohoku University School of Medicine
Division name Department of Internal Medicine & Rehabilitation Science
Zip code 980-8574
Address 1-1 Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7351
Email kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Yoshihiko
Middle name
Last name Baba
Organization Tohoku University School of Medicine
Division name Department of Internal Medicine and Rehabilitation Science
Zip code 980-8574
Address 1-1 Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7353
Homepage URL
Email babayoshihiko@mac.com

Sponsor
Institute Department of Internal Medicine and Rehabilitation Science, Tohoku University Graduate School of Medicine
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 Tohoku University Hospital Ethics Committee
Address Seiryo 1-1, Aoba-ku, Sendai, Japan
Tel 022-728-4105
Email rinri-2@proj.med.tohoku.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
2017 Year 07 Month 21 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 96
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
2017 Year 08 Month 01 Day
Date of IRB
2017 Year 12 Month 01 Day
Anticipated trial start date
2017 Year 08 Month 20 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 21 Day
Last modified on
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.