UMIN-CTR Clinical Trial

Basic information
Public title	Effects of an adapted sports intervention on elderly women in need of long-term care: A pilot study
Acronym	Effects of an adapted sports intervention on elderly women in need of long-term care
Scientific Title	Effects of an adapted sports intervention on elderly women in need of long-term care: A pilot study -- A non-randomized open label clinical trial --
Scientific Title:Acronym	Effects of an adapted sports intervention on elderly women in need of long-term care -- A non-randomized open label clinical trial --
Region	Japan

Condition
Condition	Elderly women in need of long-term care
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to clarify the effects of boccia exercise on elderly women in need of long-term care and examine the changes in mood state and health-related quality of life after intervention with boccia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Profile of Mood States-Short Form 2nd Edition (POMS2-SF)
Key secondary outcomes	Medical Outcomes Study 36-Item Short-Form Health Survey Version 2 (SF-36v2)

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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	The boccia exercise intervention will be implemented once a week (50 minutes) for a total of 4 sessions over a 4-week period.
Interventions/Control_2	The boccia exercise intervention will be implemented once a week (50 minutes) for a total of 4 sessions over a 4-week 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	65 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	An elderly woman in need of care is recruited at the local adult day health center in Y city. The patient's pathology and type of disability will be examples of paralysis due to stroke, osteoarthritis, and fracture. Healthy elderly women over 65 years of age will be used as the control group.
Key exclusion criteria	An individual with complete paralysis of the upper limb was not included in the study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kawano
Organization	Hiroshima Bunka Gakuen University
Division name	Department of Sports, Health and Well-being, Faculty of Human Health Science
Zip code	731-4312
Address	3-3-20 Heiseigahama, Akigunsakacho, Hiroshima 731-4312, Japan
TEL	0828841001
Email	kawano@hbg.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kawano
Organization	Hiroshima Bunka Gakuen University
Division name	Department of Sports, Health and Well-being, Faculty of Human Health Science
Zip code	731-4312
Address	3-3-20 Heiseigahama, Akigunsakacho, Hiroshima 731-4312, Japan
TEL	0828841001
Homepage URL
Email	kawano@hbg.ac.jp

Sponsor
Institute	Hiroshima Bunka Gakuen University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Department Research Ethics Committee of Hiroshima Bunka Gakuen University
Address	3-3-20 Heiseigahama, Akigunsakacho, Hiroshima 731-4312, Japan
Tel	0828841001
Email	s-soumu@hbg.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	2022 Year 03 Month 05 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	20
Results	The POMS2 score (anger-hostility: AH, fatigue-inertia: FI, tension-anxiety: TA, friendliness: F, total mood disturbance: TMD) presented significant interaction effects. The intervention group: IG expressed significant improvements in AH, TA, TMD. In contrast, the control group: CG showed significant worsening in FI and F. In the SF-36v2 score, only bodily pain: BP showed a significant interaction effect, while the CG showed significant worsening in BP.
Results date posted	2022 Year 03 Month 05 Day
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	2018 Year 10 Month 25 Day
Date of IRB	2018 Year 12 Month 19 Day
Anticipated trial start date	2019 Year 03 Month 06 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 01 Day
Date trial data considered complete	2021 Year 08 Month 31 Day
Date analysis concluded	2021 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2022 Year 03 Month 05 Day
Last modified on	2022 Year 03 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053714