UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045467 |
|---|---|
| Receipt number | R000051911 |
| Scientific Title | Comparison of the effects of aerobic exercise and muscle strength exercise/stretching for patients with lumbar spinal stenosis |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2021/09/15 07:16:54 |
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Basic information
Public title
Comparison of the effects of aerobic exercise and muscle strength exercise/stretching for patients with lumbar spinal stenosis
Acronym
Comparison of the effects of aerobic exercise and muscle strength exercise/stretching for patients with lumbar spinal stenosis
Scientific Title
Comparison of the effects of aerobic exercise and muscle strength exercise/stretching for patients with lumbar spinal stenosis
Scientific Title:Acronym
Comparison of the effects of aerobic exercise and muscle strength exercise/stretching for patients with lumbar spinal stenosis
Region
| Japan |
Condition
Condition
Lumbar spinal stenosis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the therapeutic effect from the viewpoint of systemic hemodynamics after comparing aerobic exercise with conventional exercise therapy (stretching, muscle strength exercise) for the symptoms of lumbar spinal stenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oswestry Disability Index(Baseline, 12weeks after intervention)
Key secondary outcomes
Flexibility
Muscle endurance/muscle strength
Consecutive walk distance
peak oxygen uptake, Anaerobic threshold
(All indicators at baseline and 12weeks after intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Aerobic exercise
Interventions/Control_2
Muscle strength exercise/stretching
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnosis of lumbar spinal stenosis by an orthopedic surgeon based on imaging findings
Key exclusion criteria
1.Muscle weakness (less than 3 controlled muscles in stenotic radiculopathy by Manual Muscle Testing),
2.Uncontrolled diabetes (HbA1c is 7.0 or higher)
3. Use of antidepressants and psychotropic drugs
4. Complication of spinal cord lesions with paralysis
5. Symptomatic arteriosclerosis obliterans (ankle brachial pressure index less than 0.9)
6. Rheumatoid arthritis
7. Artificial dialysis
8. Those who have been diagnosed with myocardial infarction, angina, acute and chronic heart failure in the past
9.History of spine surgery
10.osteoporosis
11.Medication of Opioid analgesics
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Sugita |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-0821
Address
4-12-7, Kasuga, Tsukuba-shi, Ibaraki, Japan
TEL
0298589568
y.sugita@cc.k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Yousuke |
| Middle name | |
| Last name | Sugita |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-0821
Address
4-12-7, Kasuga, Tsukuba-shi, Ibaraki, Japan
TEL
0298589568
Homepage URL
y.sugita@cc.k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University of Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tsukuba University of Technology Center for Integrative Medicine
Address
4-12-7, Kasuga, Tsukuba-shi, Ibaraki, Japan
Tel
0298589568
y.sugita@cc.k.tsukuba-tech.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-03
Org. issuing International ID_1
Tsukuba University of Technology Center for Integrative Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立大学法人筑波技術大学保健科学部附属東西医学統合医療センター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051911
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