UMIN-CTR Clinical Trial

Basic information
Public title	The effects of interventions on physical activity in older adults with knee pain a systematic review and meta-analysis
Acronym	The effects of interventions on physical activity in older adults with knee pain a systematic review and meta-analysis
Scientific Title	The effects of interventions on physical activity in older adults with knee pain a systematic review and meta-analysis
Scientific Title:Acronym	The effects of interventions on physical activity in older adults with knee pain a systematic review and meta-analysis
Region	Japan

Condition
Condition	knee osteoarthritis,Chronic pain
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine how interventions in the amount of physical activity in daily life affect knee pain in the elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in knee pain reported as a clinical diagnosis or validated self-report measure (e.g.,Knee injury and Osteoarthritis Outcome Score(KOOS), Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC))from baseline
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	50 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) It is an exercise and educational intervention aimed at increasing physical activity. (2) The intervention is non-face-to-face or face-to-face for the first time only. (3) The outcome includes a measure of physical activity. (4) The article is an original research paper (5) The study design is a randomized controlled trial (6) The article is written in English or Japanese
Key exclusion criteria	(1) The intervention consists of multiple programs. (2) The intervention does not aim to increase physical activity. (3) Multiple face-to-face interventions are conducted. (4) Not enough data are reported to integrate the results.
Target sample size

Research contact person
Name of lead principal investigator	1st name Kenta Middle name Last name Hirohama
Organization	Hiroshima University
Division name	Graduate School of Humanities and Social Sciences
Zip code	739-8511
Address	1-3-2 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL	082-424-6306
Email	hirohama@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Hirohama
Organization	Hiroshima University
Division name	Graduate School of Humanities and Social Sciences
Zip code	739-8511
Address	1-3-2 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL	082-424-6306
Homepage URL
Email	hirohama@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	JSPS KAKENHI
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	1)Faculty of Health Sciences, Hiroshima Cosmopolitan University 2)Faculty of Medical Science, Fukuoka International 3)Graduate school of Humanities and Social Sciences, Hiroshima
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Hiroshima University
Address	1-3-2 Kagamiyama, Higashi-Hiroshima City, Hiroshima
Tel	082-424-6306
Email	hirohama@hiroshima-u.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	2021 Year 06 Month 22 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	Preinitiation
Date of protocol fixation	2021 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 22 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Methods: In June 2021, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Physiotherapy Evidence Database (PEDro), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Central Journal of Medicine (Igaku Chujo). Searches were conducted using a combination of free-text words and Medical Subject Headings (MeSH) terms. Two concepts, "intervention" and "outcome," were combined using the "AND" operator. Intervention was defined as an exercise or educational intervention aimed at increasing physical activity. Outcome was defined as knee pain. For each concept, synonyms and MeSH terms were combined with the "OR" operator.

Management information
Registered date	2021 Year 06 Month 22 Day
Last modified on	2021 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050962