UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041626 |
|---|---|
| Receipt number | R000047519 |
| Scientific Title | Effects of high-intensity interval walking training in patients with rheumatoid arthsritis |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2024/09/04 18:15:36 |
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Basic information
Public title
Effects of high-intensity interval walking training in patients with rheumatoid arthsritis
Acronym
Effects of high-intensity interval walking training in patients with rheumatoid arthsritis
Scientific Title
Effects of high-intensity interval walking training in patients with rheumatoid arthsritis
Scientific Title:Acronym
Effects of high-intensity interval walking training in patients with rheumatoid arthsritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The patients with rheumatoid arthritis are more likely to decrease the amount of physical activity, they need to exercise in order to maintain and improve physical strength. However, so that the exercise is not overloaded, it is necessary to individually prescribe the intensity of exercise for each patient. High-intensity interval walking, in the intensity of the individual formulation, a simple exercise to repeat the fast walk and normal walking, physical strength improvement effect has been observed in the general population. This study examines the effect of interval walking in patients with rheumatoid arthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change and the amount of change in maximum physical strength, grip strength, walking speed, and body composition from start of intervention to finish(20 weeks).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
High-intensity interval walking for 20 weeks.
Wearing an activity meter, walk fast for 3 minutes and walk slowly for 3 minutes.
Walk fast for a total of 60 minutes or more per week.
Strength is 70% of maximum physical strength.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patient is at least 20 years of age.
2) The patient meet the 2010 ACR/EULAR RA classification criteria.
3) The patient can walk.
4) After receiving a sufficient explanation for participation in this study, the patient's free-willed consent has been obtained with sufficient understanding.
Key exclusion criteria
The patient has been instructed to exercise restrictions by the patient's doctor.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Takeuchi |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Internal Medicine 4
Zip code
5698686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
0726831221
tooru.takeuchi@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Tokai |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Internal Medicine 4
Zip code
5698686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
0726831221
Homepage URL
nao.tokai@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe City Collage of Nursing, Komachi Clinic for Rheumatology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi, Takatsuki, Osaka
Tel
0726831221
rinri@ompu.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
Other administrative information
Date of disclosure of the study information
| 2021 | 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
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
Suspended
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047519
