UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038438
Receipt number R000043796
Scientific Title Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial
Date of disclosure of the study information 2019/11/10
Last modified on 2023/05/03 11:25:48

* 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 behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial

Acronym

Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial

Scientific Title

Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial

Scientific Title:Acronym

Effectiveness of behavioral scientific intervention using buddy style to improve exercise adherence of community-dwelling disabled elderly people: a randomized controlled trial

Region

Japan


Condition

Condition

elderly people requiring support or care

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify whether buddy-style intervention among community-dwelling elderly people is effective for improving exercise adherence

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Exercise adherence

Key secondary outcomes

Number of falls, Short Physical Performance Battery, Exercise self-efficacy, Apathy scale, Health Locus of Control scale, Grip strength, Knee extension muscle strength, Subjective health


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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The physical therapy handbook (healthy life expectancy) published by the Japan Physical Therapist Association is handed over to the subjects, and the physical therapist's advice is given to select three exercises. Each intervention group becomes a pair (buddy), and the buddies report the progress of exercise every week and receive behavioral change interventions such as social support, feedback, and monitoring.

Interventions/Control_2

The physical therapy handbook (healthy life expectancy) published by the Japan Physical Therapist Association is handed over to the subject, and the subject chooses three exercises themselves.

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

Aged 65 years or older living in a home or residential facility

gait independence

Key exclusion criteria

Severe visual impairment that prevents you from reading an exercise program form or completing an exercise logbook

Cognitive impairment

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hiromichi
Middle name
Last name Takeda

Organization

Kio University

Division name

Division of Health Science, Graduate School

Zip code

635-2832

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Email

hiromichi.takeda0608@gmail.com


Public contact

Name of contact person

1st name Hiromichi
Middle name
Last name Takeda

Organization

Kio University

Division name

Division of Health Science, Graduate School

Zip code

635-2832

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Homepage URL


Email

hiromichi.takeda0608@gmail.com


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kio University

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

Tel

0745-54-1602

Email

soumu@kio.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

2019 Year 11 Month 10 Day


Related information

URL releasing protocol

https://doi.org/10.1177/02692155211041104

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1177/02692155211041104

Number of participants that the trial has enrolled

65

Results

The analysis of exercise adherence was performed on the 54 participants (intervention, n=28, control, n=26) for whom the final responses were available. The between-group effect showed that the intervention group was significantly higher than the control group in phase 3 of the exercise adherence assessment (p = 0.009, f = 0.4). On the other hand, the control group was significantly better than the intervention group in tandem standing time after 12 weeks (p = 0.049, f = 0.2).

Results date posted

2023 Year 05 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Support/care-need disabled older adults in the long-term care insurance system were recruited from three adult day-care centers in Osaka City, Japan, between June 2020 and July 2020. The criteria for selecting participants were older adults aged >65 who lived in the community and could walk independently.
Exclusion criteria were those with visual impairment or deterioration of upper limb/finger function who would be incapable of writing in an exercise log calendar, and those with moderate and severe cognitive impairment in which the independence degree of daily living for the demented elderly was IIb or higher.

Participant flow

In total, 590 older adults of three adult day-care centers in Osaka, Japan, were checked for eligibility in August 2020. During the 12-week intervention period from September 2020 to December 2020, a total of nine participants dropped out (intervention = 4, control = 5). The mean adherence for the buddy-style intervention was 9.7/12 times (81%).

Adverse events

None

Outcome measures

Exercise adherence (primary outcome)
Handgrip strength
Knee extension strength
Self-efficacy for exercise scale
Apathy scale
Health locus of control scale
Self-rated health

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 10 Month 30 Day

Date of IRB

2019 Year 11 Month 27 Day

Anticipated trial start date

2020 Year 01 Month 04 Day

Last follow-up date

2020 Year 10 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

2019 Year 10 Month 30 Day

Last modified on

2023 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043796


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name