UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021392 |
|---|---|
| Receipt number | R000024672 |
| Scientific Title | Effect of low intensity exercise on community dwelling elderly |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2023/09/19 15:38:07 |
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Basic information
Public title
Effect of low intensity exercise on community dwelling elderly
Acronym
Effect of low intensity exercise on community dwelling elderly
Scientific Title
Effect of low intensity exercise on community dwelling elderly
Scientific Title:Acronym
Effect of low intensity exercise on community dwelling elderly
Region
| Japan |
Condition
Condition
Healthy community dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of low intensity exercise intervention on daily physical activity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
> behavior factors: physical activity monitoring by triaxial accelerometer on the hip
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The exercise program is described elsewhere (http://www.kyoto-houkatucare.org/kaigo-yobou-manual/). The participants will conduct the exercise program in one 90 min session class per week. The participants will log their daily step count and exercise duration for the intervention period.
The intervention duration is 12 weeks.
Interventions/Control_2
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
The subjects who participate the exercise program habitually and preserve the protocol.
Key exclusion criteria
The subjects who are evaluated as inadequate subjects by principal or co-principal investigators, or responsible medical doctor because of difficulty of exercise conducting.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Misaka |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University of Advanced Science
Division name
Institute of Interdisciplinary Research
Zip code
621-8577
Address
1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL
0771-56-8930
kimura.misaka@kuas.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Yokoyama |
Organization
Kyoto University of Advanced Science
Division name
Institute of Interdisciplinary Research
Zip code
651-8277
Address
1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL
0771-29-2354
Homepage URL
yoshinaka.yasuko@kuas.ac.jp
Sponsor or person
Institute
Institute of Interdisciplinary Research,
Kyoto University of Advanced Science
Institute
Department
Personal name
Funding Source
Organization
Institute of Interdisciplinary Research,
Kyoto University of Advanced Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University of Advanced Science
Address
1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
Tel
0771-29-2393
nonami.seisuke@kyotogakuen.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
| 2016 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
doi: 10.2147/CIA.S151427
Publication of results
Published
Result
URL related to results and publications
doi: 10.2147/CIA.S151427
Number of participants that the trial has enrolled
526
Results
In this study, both various physical functions and physical activity (number of steps) increased in the intervention group. It was a similar effect in both the home-based and classroom-based groups.
Results date posted
| 2023 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The cluster RCT involved random allocation of regions as intervention (n=4,859) and nonintervention (n=7,195). Participants were elderly persons aged 65 years of age or older without LTC certification who had responded to a mailing survey. The residents living in intervention regions were invited to a physical check-up, and 1,463 people participated (30.3%). These individuals were invited to the CGIP, and 526 accepted. The CGIP comprised instructions on: 1) low-load resistance training using bodyweight, ankle weights, and elastic bands; 2) increasing daily physical activity; 3) oral motor exercise and care; and 4) a well-balanced diet based on a program from Ministry of Health, Labour and Welfare. We allocated the intervention regions randomly into home-based self-care program alone (HB group, 5 regions, n=275) and home-based program+weekly class-style session (CS group, 5 regions, n=251). We evaluated the effects of the CGIP at 12 weeks and at 12 or 15 months on physical function, and are conducting follow-up data collection for an indefinite period regarding LTC certification, medical costs, and mortality.
Participant flow
A baseline survey was conducted for all elderly people in Kameoka City, excluding those requiring nursing care level 3 or above. Respondents were divided into intervention and non-intervention areas.Physical function measurements were carried out in the intervention areas. Interventions were provided to those who participated or who wished to participate. This is the intervention group.The non-intervention group was selected from non-intervention areas.
Adverse events
nothing special
Outcome measures
Incidence of frailty, sarcopenia, and need for nursing care. Physical function (physical strength), amount of physical activity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 13 | 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
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024672
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