UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Benefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls in the Community-dwelling Older adults.
Title of the study (Brief title)	enefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls
Region	Japan

Condition
Condition	Frail older adults
Classification by specialty	Geriatrics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the home-based exercise with the aim to preventing aspiration pneumonia and accidental falls improve swallowing-related functions and physical functions in the community-dwelling older adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximal peak cough flow Lip closure pressure Incident of accidental fall
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	We instructed the participants to perform the exercise program at home at least three times a week for 6 months. The home-based exercise program had 12 elements that combined stretching, breathing exercises,balance training, muscle strengthening and dual-task training.
Interventions/Control_2	Participants in control group were advised to maintain or improve their activity in daily life and attend lectures on health.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Older adults whom Independence of self care activity.
Key exclusion criteria	Subjects with dementia or severe cognitive disorder.
Target sample size	100

Research contact person
Name of lead principal investigator	Katsuhiko Takatori
Organization	Kio University
Division name	Faculty of Health Science
Address	4-2-2, Umami-naka,Koryo,Kitakatsuragi-gun,Nara
TEL	0745-54-1601
Email	k.takatori@kio.ac.jp

Public contact
Name of contact person	Katsuhiko Takatori
Organization	Kio University
Division name	Faculty of Health Science
Address	4-2-2, Umami-naka,Koryo,Kitakatsuragi-gun,Nara
TEL	0745-54-1601
Homepage URL
Email	k.takatori@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nothing
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

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://bmjopensem.bmj.com/
Results	Voluntary peak cough flow in the intervention group was significantly greater than in the control group (p<0.01, d=0.5). However, lip closure force did not differ between groups. Regarding physical function, results of the Timed Up and Go Test (p<0.05, d=0.4), Chair Stand Test (p<0.01, d=0.4), maximal knee extension strength (p<0.05, d=0.4), and Sit and Reach Test (p<0.05, d=0.3) showed greater improvement in the intervention group.
Other related information

Management information
Registered date	2014 Year 08 Month 18 Day
Last modified on	2016 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017305