UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030853
Receipt number R000035222
Scientific Title Intervention of low-intensity bodyweight training with slow movement on motor function in frail elderly patients
Date of disclosure of the study information 2018/01/17
Last modified on 2022/03/23 15:37:49

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Basic information

Public title

Intervention of low-intensity bodyweight training with slow movement on motor function in frail elderly patients

Acronym

Intervention of LST bodyweight training

Scientific Title

Intervention of low-intensity bodyweight training with slow movement on motor function in frail elderly patients

Scientific Title:Acronym

Intervention of LST bodyweight training

Region

Japan


Condition

Condition

frail elderly

Classification by specialty

Geriatrics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study evaluated the effects of low-intensity bodyweight training with slow movement on motor function in frail, elderly patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome was the difference in mean values obtained from the Timed Up & Go test (TUG, for evaluating the ability to perform compound motions).

Key secondary outcomes

The secondary outcomes were the differences in mean values obtained from the chair-stand test (lower-limb muscle strength), and the one-leg standing test with eyes open (balance ability).


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

(1) A level of nursing care classified as either support required (1 and 2) or long-term care required (Care level 1 and 2); (2) Persons judged by examiner in charge to be able to exercise at rehabilitation day service;(3) Persons who can regularly visit the rehabilitation day service at least once a week;(4) Informed consent was obtained from the participants;(5) 65 years old and over

Key exclusion criteria

(1) those who had difficulty participating in the exercise program due to apparent cognitive symptoms; (2) those who had limitations due to some reason, or when discontinuation of the ongoing program was determined to be a better option; (3) when it became difficult for the participant to continue the exercise program on a regular basis; (4) when the attending physician determined that the participant had to stop using day services because of the effects of diseases; and (5) other people whom the physician in charge of the research program determined as being inappropriate for inclusion.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Kanae
Middle name
Last name Kanda

Organization

Faculty of Medicine Kagawa University, Kagawa, Japan

Division name

Department of Public Health,

Zip code

761-0793

Address

1750-1 Ikenobe Miki-cho Kita-gun, Kagawa 761-0793, Japan

TEL

0878912133

Email

kanda.kanae@kagawa-u.ac.jp


Public contact

Name of contact person

1st name Kanae
Middle name
Last name Kanda

Organization

Kagawa University

Division name

Department of Public Health,

Zip code

761-0793

Address

1750-1 Ikenobe Miki-cho Kita-gun, Kagawa 761-0793, Japan

TEL

0878912133

Homepage URL


Email

kanda.kanae@kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa University, Kagawa, Japan

Institute

Department

Personal name



Funding Source

Organization

Kagawa University, Kagawa, Japan

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sin Cire Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagawa University

Address

1750-1 Ikenobe Miki-cho Kita-gun, Kagawa 761-0793, Japan

Tel

0878912133

Email

kanda.kanae@kagawa-u.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

株式会社Sin Cire(大阪府)


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 17 Day


Related information

URL releasing protocol

https://doi.org/10.1186/s12199-019-0798-4

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1186/s12199-019-0798-4

Number of participants that the trial has enrolled

96

Results

Results: Post-intervention measurements based on the results of the chair-stand test after 12 months showed significant improvements from pre-intervention levels (P<0.0001) in the LST group and MT group. Although the ability of performing the Timed Up & Go test and the ability to stand on one leg with eyes open improved in both groups, no significant change was observed. When changes after 12 months were compared between the two groups, no significant difference was observed for any variables.

Results date posted

2022 Year 03 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 06 Month 13 Day

Baseline Characteristics

This study included elderly men and women aged 65 years or older, living at nursing care facilities in Osaka, who required a level of nursing care classified as either support required (care levels 1 and 2) or long-term care required (care levels 1 and 2).

Participant flow

Participants who met any of the following criteria were excluded from the study: (1) those who had difficulty participating in the exercise program because of apparent cognitive symptoms; (2) those who had physical limitations due to effects of disease aggravation or when discontinuation of the ongoing program was determined to be a better option; (3) when it became difficult for the participant to continue the exercise program on a regular basis; (4) when the attending physician determined that the participant had to stop using day services because of the effects of diseases; and (5) other people who the physician in charge of the research program determined as being inappropriate for inclusion. The participants were recruited between March-August 2016 from two facilities. Participants at the first facility performed exercise rehabilitation therapy using LST (the LST group), and participants at the other facility performed exercise rehabilitation therapy using a machine (the control group).

Adverse events

No adverse events resulting from participation in the exercise training programs were reported.

Outcome measures

The primary outcome was the difference in mean values obtained from the Timed Up & Go test (TUG) used to evaluate the ability to perform compound motions. To determine TUG results [9,10], we measured the time required to rise from the chair and stand, walk to the landmark 3 m ahead, and to return to the chair and sit again. During each session, the measurements were performed twice, and the best value was recorded

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 03 Month 14 Day

Date of IRB

2017 Year 03 Month 14 Day

Anticipated trial start date

2017 Year 03 Month 14 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information

The number of subjects to be studied is 65 people per facility and 2 facilities, targeting a total of 130 people. One place is a slow training group and the other one is a machine training group. Measurement is done before starting training, 3 months, and 12 months. Measurement is done by a person different from the exercise program developer. A person in charge of measurement at Sin Cire Co., Ltd. calibrates the measuring device and creates a proofread record every time 20 persons' measurement of physical strength of the user is measured. We will promptly send the created proofread record to the research director. When doubts arise in the recorded contents, the research director or the cooperative researcher confirms and instructs improvement as necessary.


Management information

Registered date

2018 Year 01 Month 17 Day

Last modified on

2022 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name