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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034111
Receipt No. R000038838
Scientific Title Exercise training for improvement of locomotive syndrome and arterial stiffness: a pilot study
Date of disclosure of the study information 2018/09/13
Last modified on 2019/08/22

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Basic information
Public title Exercise training for improvement of locomotive syndrome and arterial stiffness: a pilot study
Acronym Exercise against locomotive syndrome and arterial stiffness
Scientific Title Exercise training for improvement of locomotive syndrome and arterial stiffness: a pilot study
Scientific Title:Acronym Exercise against locomotive syndrome and arterial stiffness
Region
Japan

Condition
Condition Healthy population
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of a six-week training program that involves both resistance and aerobic exercises on locomotive function and arterial stiffness in middle-aged and older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [Before and after the six-week intervention]
- Locomotive function
- Arterial stiffness
Key secondary outcomes [Before and after the six-week intervention]
- Body mass/composition
- Waist circumference
- Peak oxygen uptake
- Blood chemistry parameters (e.g., glucose and lipids)
- Circulating factors (e.g., cytokines)
- Blood pressure at rest
- Acute response of blood pressure to exercise
- Maximum muscular strength
- Flexibility

[Two weeks before the intervention and during the six-week intervention]
- Physical activity energy expenditure (intensity and time)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
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 An intervention group: a six-week exercise program that includes a 10 min warm-up session followed by a 30 min resistance exercise and 30 min aerobic exercise session and concludes with a 5 min cool-down session. A day a week under the supervision of exercise instructors and three days a week without the supervision. The resistance exercise session basically consists of bodyweight workouts, and the intensity and repetition are gradually and individually increased according to the participant's fitness. The aerobic exercise session is mainly composed of a walking program that targets 60-75% of the participant's age-predicted maximal heart rate.
Interventions/Control_2 A control group: maintenance of usual lifestyle.
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

Not applicable
Gender Male and Female
Key inclusion criteria -
Key exclusion criteria - A history of cardiovascular disease
- Currently taking medication for hypertension
- Currently smoking
- Currently exercising (at high intensity) at least two days a week
- Difficulties in exercise
- Current participation or intention to participate in other clinical trials
- Considered ineligible judged by the principal investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Otsuki
Organization Ryutsu Keizai University
Division name Faculty of Health and Sport Sciences
Zip code 301-8555
Address 120 Ryugasaki, Ibaraki, Japan
TEL 0297-60-1933
Email otsuki-takeshi@rku.ac.jp

Public contact
Name of contact person
1st name Asako
Middle name
Last name Zempo
Organization Ryutsu Keizai University
Division name Faculty of Health and Sport Sciences
Zip code 301-8555
Address 120 Ryugasaki, Ibaraki, Japan
TEL 0297-60-1966
Homepage URL
Email zempo@rku.ac.jp

Sponsor
Institute Ryutsu Keizai University
Institute
Department

Funding Source
Organization Ryutsu Keizai University
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 The Research Ethics Committee of Ryutsu Keizai University
Address 120 Ryugasaki, Ibaraki, Japan
Tel 0297-64-0001
Email soumu@rku.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
2018 Year 09 Month 13 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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 05 Month 22 Day
Anticipated trial start date
2018 Year 09 Month 14 Day
Last follow-up date
2019 Year 12 Month 05 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 09 Month 12 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038838

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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