UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033744 |
|---|---|
| Receipt number | 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 14:40:09 |
* 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
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
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
yihungliao.henry@gmail.com
Sponsor or person
Institute
National Taipei University of Nursing and Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038488
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
