UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effects of exercise programs for older adults with frail and frail risk
Acronym	Study on the effects of exercise programs for older adults with frail and frail risk
Scientific Title	Study on the effects of exercise programs for older adults with frail and frail risk
Scientific Title:Acronym	Study on the effects of exercise programs for older adults with frail and frail risk
Region	Japan

Condition
Condition	frail
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of physical exercise for older adults with frailty
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL score
Key secondary outcomes	Frail status,Physical function (grip strength, leg strength, gait speed, Short Physical Performance Battery (SPPB), Muscle mass (BIA), Cerebral blood flow, Bone density, Cognitive function, Psychological indicators,

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: group-based exercise program
Interventions/Control_2	Control group: Individual exercise
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Older people at high risk of needing long-term care 2.Give a written informed consent to the participation in the present study 3. Willingness to continue exercising
Key exclusion criteria	1.Have serious or unstable illnesses 2.Suspected of severe dementia 3.Have a problem in the safe implementation of exercise
Target sample size	40

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 Mana Middle name Last name Tateishi
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	m-tateishi@health.nop.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	Kagoshima University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kagoshima Medical Professional College
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagoshima Medical Professional College
Address	5417-1 Utsuguchi, Hirakawa-cho, Kagoshima-city, Kagoshima 891-0133 Japan
Tel	099-261-6161
Email	pt.taniguchi@harada-gakuen.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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 28 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	31
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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 20 Day
Date of IRB	2020 Year 10 Month 20 Day
Anticipated trial start date	2021 Year 04 Month 14 Day
Last follow-up date	2021 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 28 Day
Last modified on	2021 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050660