UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036614
Receipt number R000041712
Scientific Title Standardization and verification of exercise for sarcopenia -randomized controlled trial-
Date of disclosure of the study information 2019/04/26
Last modified on 2020/10/26 10:42:53

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Basic information

Public title

Standardization and verification of exercise for sarcopenia -randomized controlled trial-

Acronym

Standardization and verification of exercise for sarcopenia -randomized controlled trial-

Scientific Title

Standardization and verification of exercise for sarcopenia -randomized controlled trial-

Scientific Title:Acronym

Standardization and verification of exercise for sarcopenia -randomized controlled trial-

Region

Japan


Condition

Condition

Frail older adults (sarcopenia)

Classification by specialty

Geriatrics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effect of exercise therapy (sarcocise) for sarcopenia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle strength (grip strength, leg strength), Muscle mass(by BIA,MRI), Lower thigh circumference, Prevalence of sarcopenia

Key secondary outcomes

Physical function(gait speed, Short physical Performance Battery(SPPB): Stand and sit, Balance), 400 m walk test


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group: Program to improve muscle mass and muscle strength

Interventions/Control_2

Control group: Non-intervention

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Among the older adults, people who are classified as sarcopenia by AWGS criteria
2.Give a written informed consent to the participation in the present study

Key exclusion criteria

1.Have serious or unstable illnesses
2.Care certified
3.Suspected of severe dementia
4.Judged to have a problem in the safe implementation of exercise

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Hyuma
Middle name
Last name Makizako

Organization

Kagoshima University

Division name

Department of Physical Therapy, School of Health Sciences, Faculty of Medicine

Zip code

890-8544

Address

8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima 890-8544, Japan

TEL

099-275-6775

Email

makizako@health.nop.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Nakai

Organization

Kagoshima University

Division name

Department of Physical Therapy, School of Health Sciences, Faculty of Medicine

Zip code

890-8544

Address

8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima 890-8544, Japan

TEL

099-275-6175

Homepage URL


Email

nakai@health.nop.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

MEXT(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagoshima University Hospital

Address

8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima 890-8544, Japan

Tel

099-275-6692

Email

kufsyomu@kuas.kagoshima-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

垂水市内の施設/ Facility in Tarumizu city


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/32397192/

Number of participants that the trial has enrolled

72

Results

Among the 72 participants, 67 (93.1%) completed the trial. Group-by-time interactions on the chair stand (p = 0.02) and timed "up and go" (p = 0.01) tests increased significantly in the exercise group. Although the exercise group showed a tendency to prevent loss of muscle mass, no significant interaction effects were observed for cross-sectional muscle area and muscle volume. The 12-week exercise program improved physical function in the intervention group.

Results date posted

2020 Year 10 Month 26 Day

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

Main results already published

Date of protocol fixation

2019 Year 03 Month 18 Day

Date of IRB

2019 Year 03 Month 18 Day

Anticipated trial start date

2019 Year 04 Month 26 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 04 Month 26 Day

Last modified on

2020 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041712


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name