UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of walking, stretching, and resistance training with nordic walking poles
Acronym	The effectiveness of exercise with nordic walking poles
Scientific Title	The effectiveness of walking, stretching, and resistance training with nordic walking poles
Scientific Title:Acronym	The effectiveness of exercise with nordic walking poles
Region	Japan

Condition
Condition	metabolic syndrome, sarcopenia
Classification by specialty	Endocrinology and Metabolism Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of exercise with nordic walking poles.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	balance function at 3-6 months after intervention
Key secondary outcomes	flexibility, muscle strength of lower extremities, walking ability, functional mobility, aerobic capacity at 3-6 months after intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	The subjects of intervention group are going to receive exercise instruction of walking, stretching, and/or resistance training with nordic walking poles from certified person 3 or 4 times a month for 3 to 6 months. The subjects are also going to perform voluntary training at home during the period.
Interventions/Control_2	The subjects of control group are going to receive normal exercise instruction of walking, stretching, and/or resistance training without nordic walking poles 3 or 4 times a month for 3 to 6 months. The subjects are also going to perform voluntary training at home during the period.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Male or female of more than 20 years who has never performed exercise with nordic walking poles before.
Key exclusion criteria	Subjects with known illnesses, injuries, or mental disorders who can not perform exercise with nordic walking poles safely.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideo Matsumoto
Organization	Keio University School of Medicine
Division name	Institute for Integrated Sports Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	+81-3-3353-1211
Email	m-hideo@keio.jp

Public contact
Name of contact person	1st name Middle name Last name Shogo Tabata
Organization	Keio University School of Medicine
Division name	Institute for Integrated Sports Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	+81-3-3353-1211
Homepage URL
Email	sky_walker_590718@yahoo.co.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Institute for Integrated Sports Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	(NPO corporation) Japan Nordic Walking School
Name of secondary funder(s)	(NPO corporation) Healthy Communication Network

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 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 04 Month 01 Day
Date of IRB	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 01 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 01 Day
Last modified on	2019 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024530