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 2024/03/06 20:34:46

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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

Email

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


Email

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Medical and Pharmaceutical University

Address

2-7 Daigakumachi, Takatsuki, Osaka

Tel

0726831221

Email

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

Enrolling by invitation

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 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name