UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036614
Receipt No. 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 (Ver. 7)

* 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 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
Institute Kagoshima University
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041712