UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033744
Receipt No. R000038488
Scientific Title Effects of Chair-based Exercise Program on the Cognitive Function and Functional Fitness in Community Elder Population
Date of disclosure of the study information 2018/08/14
Last modified on 2019/10/05 (Ver. 4)

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Basic information
Public title Effects of Chair-based Exercise Program on the Cognitive Function and Functional Fitness in Community Elder Population
Acronym Effects of Chair-based Exercise on Cognition and fitness in Elderly
Scientific Title Effects of Chair-based Exercise Program on the Cognitive Function and Functional Fitness in Community Elder Population
Scientific Title:Acronym Effects of Chair-based Exercise on Cognition and fitness in Elderly
Region
Asia(except Japan)

Condition
Condition Health community elder adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether a 12-week chair-based exercise intervention can improve physical fitness and cognitive performance in community living older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Physical fitness testing, cognitive functions, and nutritional status.
Key secondary outcomes 1. Elderly physical fitness testing (strength and endurance)
2. Cognition related task performance
3. Nutritional status assessment

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 chair-based exercise training module
Interventions/Control_2 home exercise instruction with self control
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
55 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects aged between 55-80 yrs who are judged as healthy by self-reported health questionnaire.
2. Subjects who are capable of taking exercise training without physical and mental limitation.
3. Subjects who have no clinical diagnosis of dementia prior to the study.
4. Subjects who have no acute coronary artery diseases (myocardial infraction or angina)
5. Subjects who have no clinical skeletomuscular problems within 12-weeks prior to the study.
6. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria 1. Subjects with unstable angina, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who have resting SBP >180 mmHg or DBP>100 mmHg.
3. Subjects who have postural hypotension with drop of BP>20 mmHg and symptoms.
4. Subjects who have acute discomfort or infections.
5. Subjects who have uncontrolled arrhythmia.
6. Subjects who are unable to routinely participate scheduled training program or judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yi-Hung
Middle name
Last name Liao
Organization National Taipei University of Nursing and Health Sciences
Division name Department of Exercise and Health Science
Zip code 11219
Address No.365, Ming-Te Road, Peitou District,, Taipei City
TEL +886228227101
Email yihungliao.henry@gmail.com

Public contact
Name of contact person
1st name Yi-Hung
Middle name
Last name Liao
Organization National Taipei University of Nursing and Health Sciences
Division name Department of Exercise and Health Science
Zip code 11219
Address No.365, Ming-Te Road, Peitou District,
TEL +886228227101
Homepage URL
Email yihungliao.henry@gmail.com

Sponsor
Institute National Taipei University of Nursing and Health Sciences
Institute
Department

Funding Source
Organization National Taipei University of Nursing and Health Sciences
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 IRB of Fu Jen Catholic University
Address No.510, Zhongzheng Rd., Xinzhuang Dist., New Taipei City 24205, Taiwan
Tel +886-02-2903-3546
Email irb@mail.fju.edu.tw

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
2018 Year 08 Month 14 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 40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow 
The study began to enroll the first participants on August 28th 2018, and 40 participants signed informed consents and enrolled in the study before the end enrollment on September 29th 2018 (the first participant enroll date: 2018/8/28; the last participant enroll date: 2018/9/28). Finally, twenty-three subjects completed all three tests (pre-test, post-test, follow-up), and seventeen participants dropped out from the study due to their personal reasons.
Adverse events 
All subjects had reported no adverse responses during the trial.
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 22 Day
Date of IRB
2018 Year 06 Month 28 Day
Anticipated trial start date
2018 Year 06 Month 28 Day
Last follow-up date
2019 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 14 Day
Last modified on
2019 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038488