UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049567 |
|---|---|
| Receipt number | R000056450 |
| Scientific Title | The effect of exercise-induced hypoalgesia in elderly patients with subacute musculoskeletal disease: a randomized controlled trial |
| Date of disclosure of the study information | 2022/11/21 |
| Last modified on | 2022/11/20 23:51:13 |
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Basic information
Public title
The effect of exercise-induced hypoalgesia in elderly patients with subacute musculoskeletal disease: a randomized controlled trial
Acronym
Hypoalgesic effect of exercise in elderly patients with subacute musculoskeletal disease
Scientific Title
The effect of exercise-induced hypoalgesia in elderly patients with subacute musculoskeletal disease: a randomized controlled trial
Scientific Title:Acronym
Hypoalgesic effect of exercise in elderly patients with subacute musculoskeletal disease
Region
| Japan |
Condition
Condition
Proximal femoral fracture, Vertebral compression fracture, Hip osteoarthritis, Knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of exercise-induced hypoalgesia in elderly patients with subacute musculoskeletal disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative sensory testing
Key secondary outcomes
Subjective pain intensity
Physical function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Standard physical therapy (40- 45 minutes) and aerobic exercise (15- 20 minutes)
Four weeks
Three times a week
Interventions/Control_2
Standard physical therapy (60 minutes)
Four weeks
Three times a week
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
(1) The patients with diagnosis of vertebral compression fracture
(2) The patients with proximal femoral fracture or hip or knee osteoarthritis after surgery
Key exclusion criteria
(1) The patients with fracture other than proximal femoral fracture or vertebral compression fracture
(2) The patients who are unable to walk
(3) The patients who are difficult to evaluate due to significant cognitive impairment
(4) The patients with past medical history of neurological disease
(5) The patients with severe medical comorbidities (e.g., cerebrovascular disease, heart failure, chronic obstructive pulmonary disease, or cancer)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL
078-974-1551
matsubar@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL
078-974-1551
Homepage URL
matsubar@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
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
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
Tel
078-974-1551
ethic@reha.kobegakuin.ac.jp
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
済衆館病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 20 | Day |
Last modified on
| 2022 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056450
