UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003010 |
|---|---|
| Receipt number | 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 15:22:43 |
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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
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
koka@waseda.jp
Sponsor or person
Institute
Faculty of Sport Sciences Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003645
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