UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005072 |
|---|---|
| Receipt number | R000006035 |
| Scientific Title | Effects of chair exercises on physical function and mental health in elderly patients with cardiac diseases-A pilot study |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2024/02/23 09:35:57 |
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Basic information
Public title
Effects of chair exercises on physical function and mental health in elderly patients with cardiac diseases-A pilot study
Acronym
Effects of chair exercises in elderly patients with cardiac diseases
Scientific Title
Effects of chair exercises on physical function and mental health in elderly patients with cardiac diseases-A pilot study
Scientific Title:Acronym
Effects of chair exercises in elderly patients with cardiac diseases
Region
| Japan |
Condition
Condition
Elderly patients with cardiac diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and the efficacy of a chair exercise program we developed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Six-minute walk distance
Key secondary outcomes
Grip strength, capacity for sense of balance, state of depression, heart rate variability, plasma brain natriuretic peptide level, serum LDL cholesterol level, serum HDL cholesterol level, and blood HbA1c level.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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 exercises
Interventions/Control_2
Ordinary care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients older than or equal to 65 years old who receive regular outpatient treatment at the Department of Cardiovascular Medicine, Kyoto University Hospital.
Key exclusion criteria
Unstable hemodynamic status (uncontrolled hypertension, uncontrolled arrhythmia, uncontrolled congestion)
Severe aortic valve disease
Active inflammatory disease
Terminal cancer
Chronic renal failure requiring hemodialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Japan
TEL
+81757514255
nei126@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Japan
TEL
+81757514255
Homepage URL
nei126@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Nakatomi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2011 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://search-jamas-or-jp.kyoto-u.idm.oclc.org/search/do
Publication of results
Published
Result
URL related to results and publications
https://search-jamas-or-jp.kyoto-u.idm.oclc.org/search/do
Number of participants that the trial has enrolled
23
Results
No cardiovascular events or significant increases in BNP levels were observed during the study period.
The mean 6-minute walking distance increased from 412.3+-104.4 m to 433.7+-15.8 m (p<O.05), and the mean time to stand on one leg with open eyes increased from 12.0+-12.4 s to 20.9+-24.7 s (p<O.05), respectively. The CES-D score, a measure of mental health, showed no significant change.
Results date posted
| 2024 | Year | 02 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2014 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
Patients were elderly cardiac patients aged 65 years or older attending the outpatient clinic of the Department of Cardiology, Kyoto University Hospital between June 2011 and May 2012, and consecutive patients who gave consent to participate in the study. Exclusion criteria were patients with hemodynamic instability (uncontrolled hypertension, congestive heart failure, arrhythmia, severe aortic stenosis, or regurgitation), active inflammatory disease, terminal cancer, and dialysis patients. Before the start of exercise therapy, blood pressure measurements, blood tests, electrocardiography, and echocardiography were performed as screening tests to confirm that the patients did not meet the exclusion criteria.
Participant flow
The intervention consisted of 35 minutes of chair exercise in an outpatient cardiac rehabilitation clinic twice a week for 8 weeks, and each of the following measures was assessed at the beginning and after 8 weeks. The chair exercise was performed using a DVD containing the exercise program and a chair positioned in front of a 42-inch monitor screen. As in the usual cardiac rehabilitation program, the subjects' subjective symptoms were checked by pre- and post-exercise vital checks, electrocardiogram monitoring, and Borg scale.
The patients were monitored by a physical therapist and a nurse under the supervision of a physician. During the intervention period, only chair exercises were performed during cardiac rehabilitation, and no special exercise instruction other than chair exercises was provided.
Adverse events
There were no accidents or cardiovascular events associated with exercise therapy during the study period. No accidents or cardiovascular events associated with exercise therapy during the study period were observed, nor were there any cases of osteoarticular disease.
Outcome measures
　Anthropometric parameters such as age, height, weight, body mass index (BMI), and abdominal circumference were recorded. Blood samples were taken for brain natriuretic peptide (BNP), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol
(LDL-C) as indices of physical performance, 6-minute walking distance, time to stand on one leg with eyes open, and grip strength were measured. The center for epidemilogic studiesdepression scale (CES-D) was used to assess depression.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety and effecs of chair exercise training for elderly patients with cardiocascular diseases
JJCR 19;95-99.2014
Management information
Registered date
| 2011 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006035
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