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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030853
Receipt No. 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 2018/01/17

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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
Middle name
Last name Kanae Kanda
Organization Faculty of Medicine Kagawa University, Kagawa, Japan
Division name Department of Public Health,
Zip code
Address 1750-1 Ikenobe Miki-cho Kita-gun, Kagawa 761-0793, Japan
TEL 087-891-2133
Email oda@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanae Kanda
Organization Faculty of Medicine Kagawa University, Kagawa, Japan
Division name Department of Public Health,
Zip code
Address 1750-1 Ikenobe Miki-cho Kita-gun, Kagawa 761-0793, Japan
TEL 087-891-2133
Homepage URL
Email oda@med.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 Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sin Cire Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 01 Month 17 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
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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.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


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