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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021909
Receipt No. 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 2019/12/11

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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
Email 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
Email kimura.misaka@kuas.ac.jp

Sponsor
Institute Institute of Interdisciplinary Research,
Kyoto University of Advanced Science
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 14 Day
Last follow-up date
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
2019 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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