UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007132 |
|---|---|
| Receipt number | 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 22:07:03 |
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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
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
billabonghonor@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization, Nanao Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008398
