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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007132
Receipt No. R000008398
Scientific Title Effect of body weight support walking on exercise capacity and walking speed in patients with knee osteoarthritis: a randomized controlled trial.
Date of disclosure of the study information 2012/02/01
Last modified on 2012/01/24

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Basic information
Public title Effect of body weight support walking on exercise capacity and walking speed in patients with knee osteoarthritis: a randomized controlled trial.
Acronym To compare the effect of body-weight-supported treadmill training (BWSTT) and full-body-weight treadmill training (FBWTT) on patients with knee osteoarthritis.
Scientific Title Effect of body weight support walking on exercise capacity and walking speed in patients with knee osteoarthritis: a randomized controlled trial.
Scientific Title:Acronym To compare the effect of body-weight-supported treadmill training (BWSTT) and full-body-weight treadmill training (FBWTT) on patients with knee osteoarthritis.
Region
Japan

Condition
Condition Knee osteoarthritis patients
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of body-weight-supported treadmill training (BWSTT) and full-body-weight treadmill training (FBWTT) on patients with knee osteoarthritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 10-meter walking test, 6-minute walking test ,
Key secondary outcomes functional reach test, Timed Up and Go Test , one-leg standing test, the gait parameters on treadmill, MOS Short-Form 36-Item Health Survey (SF-36), Japanese Knee Osteoarthritis Measure .

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 body weight supported treadmill training 20 minutes were performed by the patients under supervision of therapist twice a week for six weeks
Interventions/Control_2 full body weight treadmill training 6 week 20 minutes were performed by the patients under supervision of therapist twice a week for six weeks
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
90 years-old >=
Gender Male and Female
Key inclusion criteria knee OA referred to outpatient clinic in Department of Rehabilitation National Hospital Organization, Nanao Hospital from June 2010 to June 2011.
Key exclusion criteria severe coronary artery disease, dementia, acute pain, neurological symptom, and spinal compression fracture
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Watanabe
Organization National Hospital Organization, Nanao Hospital
Division name Department of Rehabilitation
Zip code
Address 3-1 Matto-machi, Nanao city, Ishikawa Prefecture Japan
TEL 0767-53-1890
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Watanabe
Organization National Hospital Organization, Nanao Hospital
Division name Department of Rehabilitation
Zip code
Address
TEL
Homepage URL
Email billabonghonor@yahoo.co.jp

Sponsor
Institute National Hospital Organization, Nanao Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanazawa University, College of Medical, Pharmaceutical and Health Sciences, School of Health Sciences, Kanazawa, Japan
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 国立病院機構七尾病院(石川県)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 01 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
the exercise strength suggested by the heart rate was the same for the groups while bwstt could be beneficial to exercise capacity and walking speed with ameliorated pain in 3 weeks but failed to improve functional abilities and qol
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
2010 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 11 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 24 Day
Last modified on
2012 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008398

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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