UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014880
Receipt No. R000017305
Scientific Title Benefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls in the Community-dwelling Older adults.
Date of disclosure of the study information 2014/09/01
Last modified on 2016/06/14

* 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 Benefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls in the Community-dwelling Older adults.
Acronym enefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls
Scientific Title Benefits of the Home-based Exercise with the Aim of Preventing Aspiration Pneumonia and Falls in the Community-dwelling Older adults.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Katsuhiko Takatori
Organization Kio University
Division name Faculty of Health Science
Zip code
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
1st name
Middle name
Last name Katsuhiko Takatori
Organization Kio University
Division name Faculty of Health Science
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://bmjopensem.bmj.com/
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.