UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021909 |
|---|---|
| Receipt number | R000025271 |
| Scientific Title | The effect of low intensity exercise intervention with and without capsaicin analogues on physical activity, fitness, body composition and psychological factors in community dwelling older adults |
| Date of disclosure of the study information | 2016/04/14 |
| Last modified on | 2020/05/02 15:11:57 |
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Basic information
Public title
The effect of low intensity exercise intervention with and without capsaicin analogues on physical activity, fitness, body composition and psychological factors in community dwelling older adults
Acronym
The effect of low intensity exercise intervention with and without capsaicin analogues in community dwelling older adults
Scientific Title
The effect of low intensity exercise intervention with and without capsaicin analogues on physical activity, fitness, body composition and psychological factors in community dwelling older adults
Scientific Title:Acronym
The effect of low intensity exercise intervention with and without capsaicin analogues in community dwelling older adults
Region
| Japan |
Condition
Condition
Healthy community dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of low intensity exercise intervention with and without capsaicin analogues on physical activity, fitness, body composition and psychological factors in community dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
> behavior factors: physical activity monitoring by triaxial accelerometer on the hip
> psychological factors: Health Related Quality of Life (SF-36) and depression (GDS)
Key secondary outcomes
> physical fitness: one-leg standing, grip strength, leg muscle power, stepping test, sit-to-stand test, timed-up-and-go test, functional reach, leg muscle strength, gait speed, locomo-25, daily activity questionnaires, exercise habits
> body composition: BMI, bioelectrical impedance analysis
> cognitive function: SC-test etc.
> sleeping quality and quantity: Pittsburgh Sleep Quality Index
> physical activity indices: exercise log, IPAQ-E
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The participants will take three capsule composed of 1.5mg of non-pungent capsaicin analogues (capsinoids) with 200mg of canola oil in the morning and evening.
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
The participants will take three capsule composed of only 200mg of canola oil in the morning and evening.
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_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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
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 has allergy to capsicum
The subjects who has a habit taking supplemental foods which may affect energy expenditure.
The subjects who has lower BMI than 18.5 kg m-2
The subjects who are evaluated as inadequate subjects by principal or co-principal investigators, or responsible medical doctor.
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
621-8555
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 | Misaka |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University of Advanced Science
Division name
Institute of Interdisciplinary Research,
Zip code
621-8555
Address
1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL
0771-29-2354
Homepage URL
kimura.misaka@kuas.ac.jp
Sponsor or person
Institute
Institute of Interdisciplinary Research,
Kyoto University of Advanced Science
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO.,INC
Organization
Division
Category of Funding Organization
Profit organization
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
18 Gotanda-cho, Yamanouchi, Ukyo-ku, Kyoto, Japan
Tel
075-406-9210
shibata.masamitsu@kuas.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 | 04 | 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
Results
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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | 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 | 04 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025271
