UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Six-month Kohzuki Exercise Program improves physical function in frail older people in multifunctional long-term care in a small group home: a randomized controlled pilot trial
Title of the study (Brief title)	The effect of physical exercise for frail older people
Region	Japan

Condition
Condition	The eligibility criteria for inclusion were (i) 65 years or older; (ii) frail (meeting the specified cut-off for three or more of the CHS frailty criteria: slow gait, weak grip, exhaustion, low energy expenditure, and weight loss) [4]; (iii) Mini-Mental State Examination [19] score >21; and (iv) absence of participation in aerobic exercise and strength training.
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the aim of this study was to determine the effect of a 6-month structured KEP on physical function in frail older people in MSGH. The hypothesis was that the KEP would improve physical function in frail older people.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Short Physical Performance Battery(SPPB)
Key secondary outcomes	Barthel Index(BI) Medical Outcomes Study 12-item Short Form Health Survey Instrument(SF-12) Geriatric Depression Scale-Short Form 15(GDS) Pittsburgh Sleep Quality Index(PSQI)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The Exercise Group participants engaged in the KEP 3 times a week for 6 months, totaling 72 sessions. All sessions began with 5 minutes of warm-up and stretching, followed by 30 minutes of lower-limb aerobic exercise using a Terasuerugo (Showadenki Co., Ltd., Osaka, Japan), and 5 minutes of cool-down and relaxation (72 sessions in all).
Interventions/Control_2	CG participants were asked to maintain their normal behavior over the same 6-month period.
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	120 years-old >
Gender	Male and Female
Key inclusion criteria	The eligibility criteria for inclusion were (i) 65 years or older; (ii) frail (meeting the specified cut-off for three or more of the CHS frailty criteria: slow gait, weak grip, exhaustion, low energy expenditure, and weight loss) [4]; (iii) Mini-Mental State Examination [19] score >21; and (iv) absence of participation in aerobic exercise and strength training.
Key exclusion criteria	The exclusion criteria for the participants were (i) any acute cardiorespiratory episode within 1 year before the study; (ii) neurological or neuromuscular disease that could interfere with the proper performance of assessment and/or exercise protocol; and (iii) dementia or psychiatric disorders.
Target sample size	110

Research contact person
Name of lead principal investigator	Masahiro Kohzuki
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Internal Medicine & Rehabilitation Science
Address	1-1, Seiryo street, Aoba ward, Sendai city
TEL	022-717-7351
Email	kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person	Chaewon Lee
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Internal Medicine & Rehabilitation Science
Address	1-1, Seiryo street, Aoba ward, Sendai city
TEL	022-717-7353
Homepage URL
Email	terramoris@dc.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東北大学大学院(宮城県)

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 16 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 26 Day
Anticipated trial start date	2016 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 02 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027492