UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028317
Receipt number 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 2021/03/03 12:00:31

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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 or person

Institute

Department of Internal Medicine and Rehabilitation Science, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



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

dx.doi.org/10.17504/protocols.io.bn8wmhxe

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

Completed

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

2021 Year 03 Month 03 Day



Link to view the page

Value
https://center6.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