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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003010
Receipt No. R000003645
Scientific Title Effects of Water-based Exercise Program among the Community-Dwelling Elderly with Lower Limb Pain: A Randomized Control Trial
Date of disclosure of the study information 2010/01/10
Last modified on 2010/01/10

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Basic information
Public title Effects of Water-based Exercise Program among the Community-Dwelling Elderly with Lower Limb Pain: A Randomized Control Trial
Acronym Effects of Water-based Exercise Program among the Elderly with Lower Limb Pain
Scientific Title Effects of Water-based Exercise Program among the Community-Dwelling Elderly with Lower Limb Pain: A Randomized Control Trial
Scientific Title:Acronym Effects of Water-based Exercise Program among the Elderly with Lower Limb Pain
Region
Japan

Condition
Condition Knee pain (osteoarthritis), Chronic low back pain
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the short-and long-term effect of 3-month water exercise program on functional fitness, health-related QOL (HRQOL), and pain among frail elderly women with lower limb pain on the community-based setting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Measurement: pre-post Intervention, 3-and 12-month follow-up
Outcomes:Health-related QOL (SF-8TM),
Physical Fitness[Upper muscular strength: grip test, lower muscular strength: 5-time stand-to-sit test (SS-5); walking ability: 5-meter walk test(5WT); Functional mobility: Timed up & go test (TUG) ; static balance: one-legged standing with eyes open (OLS-O)]
Key secondary outcomes Measurement: pre-post Intervention, 3-and 12-month follow-up
Outcomes:Knee Pain and Stiffness (Japanese
Knee Osteoarthritis Measure),
Coping strategies (Japanese short-version of Coping Strategy Questionnaire)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Participants are randomly assigned to either water exercise group (WEG) or control group (CG). The WEG first participates in a 12-week water exercise (WE) program. Duration of the WE program is 60 minutes per session once a week. Total 4 instructors (main instructor: n=1; assistant instructor: n=3) provide the WE program. The WE program consists of warming-up (5 min.), main exercise including aerobic and strength training and stretching (45 min.), and cooling-down (5-10 min.). The participants engage in the WE program wearing the water grove. Before and after each 12-WE session, the participants are assessed the resting blood pressure and heart rate as well as evaluated their health condition for safe exercise participation. Also, the participants receive 15 minutes of health education about behavioral modification from the nurse practitioners before each 12-WE session, including lifestyle modifications (e.g., exercise and diet) and pain self-coping skills. An educational booklet and group work are utilized in the health education.
Interventions/Control_2 The participants in the CG are not provided any instruction from researchers during 12-week intervention 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 Male and Female
Key inclusion criteria The community-dwelling elderly aged over 65 years with confirmed knee and/or low back pain
Key exclusion criteria Those with general medical morbidity that would be prohibited the exercises from the physician
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Oka
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima Tokorozawa, Saitama
TEL 04-2947-6781
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Oka
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima Tokorozawa, Saitama
TEL 04-2947-6781
Homepage URL
Email koka@waseda.jp

Sponsor
Institute Faculty of Sport Sciences Waseda University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

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 新潟県長岡市

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No significant differences at baseline were found between WEG and CG in all variables. TUG, SS-5, OLS-O, BP, and PCS for WEG significantly improved from pre- to post-intervention (p<0.05) whereas did not change in CG (p>0.05). WEG significantly increased in GH following intervention whereas the CG significantly decreased from pre- to post-intervention (p=0.02). (56th American College of Sports Medicine Annual Meeting, poster presentation 2009.5.28)
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
2007 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 10 Day
Last modified on
2010 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003645

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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