UMIN-CTR Clinical Trial

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
Institute	Kagawa University, Kagawa, Japan
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035222