UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of Nordic walking on willingness to volunteer work, physical or mental function among older adults: Randomized controlled trial.
Title of the study (Brief title)	The effectiveness of Nordic walking on willingness to volunteer work, physical or mental function among older adults: Randomized controlled trial.
Region	Japan

Condition
Condition	None.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effectiveness of Nordic work on willingness to volunteer, physical or cognitive function among the older adults who engage in cultural volunteer work.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Willingness to volunteer work [Physical function] Hand grip, walking speed, balance ability, time up and go test [Cognitive function] Mini-Mental State Examination, Japanese version of Montreal Cognitive Assessment, Trail-Making-Test
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Self-monitoring of physical activity Health education Nordic walking
Interventions/Control_2	Self-monitoring of physical activity Health education
Interventions/Control_3	Health education
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Engaging in cultural volunteer group. 2. Those who have anxious of walking.
Key exclusion criteria	1. individuals who have neuromuscular disease. 2. those who have heart, kidney, or liver dysfunction.
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshinori Fujiwara
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Social Participation and Community Health Research Team
Address	35-2 Sakae-cho, Itabashi, Tokyo 173-0015, Japan
TEL	03-3964-3241
Email	fujiwayo@tmig.or.jp

Public contact
Name of contact person	Yuta Nemoto
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Social Participation and Community Health Research Team
Address	35-2 Sakae-cho, Itabashi, Tokyo 173-0015, Japan
TEL	03-3964-3241
Homepage URL
Email	nemoto@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization	Unicharm Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 10 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 07 Day
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 22 Day
Last modified on	2018 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033882