UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038919
Receipt number R000044305
Scientific Title A mechanism of the hypoalgesic effects of aerobic exercise at different intensities in healthy young adults.
Date of disclosure of the study information 2019/12/18
Last modified on 2022/12/21 00:56:17

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Basic information

Public title

A mechanism of the hypoalgesic effects of aerobic exercise at different intensities in healthy young adults.

Acronym

Mechanism of the hypoalgesic effects of aerobic exercise.

Scientific Title

A mechanism of the hypoalgesic effects of aerobic exercise at different intensities in healthy young adults.

Scientific Title:Acronym

Mechanism of the hypoalgesic effects of aerobic exercise.

Region

Japan


Condition

Condition

Healthy young volunteer

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the influence of pain sensitivity, pain inhibitory system, mood, physical activity on exercise-induced hypoalgesia.

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

1. Mood
2. Physical activity


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Low, moderate, vigorus intensity (30%, 50%, 70% HRR) aerobic exercise, 30 min

Interventions/Control_2

Sedentary, 30 min

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

18 years-old <=

Age-upper limit

23 years-old >=

Gender

Male and Female

Key inclusion criteria

No current pain, no history of chronic pain desease, chronic disease and surgery.

Key exclusion criteria

menstruation

Target sample size

80


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

6512180

Address

518 Arise, Ikawadani-cho, Nishi-ku, Kobe

TEL

(078)974-1551

Email

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

6512180

Address

518 Arise, Ikawadani-cho, Nishi-ku, Kobe

TEL

(078)974-1551

Homepage URL


Email

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

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe Gakuin University

Address

518 Arise, Ikawadani-cho, Nishi-ku, Kobe

Tel

078-974-4297

Email

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



Other administrative information

Date of disclosure of the study information

2019 Year 12 Month 18 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

Completed

Date of protocol fixation

2019 Year 06 Month 05 Day

Date of IRB

2019 Year 11 Month 19 Day

Anticipated trial start date

2019 Year 11 Month 19 Day

Last follow-up date

2021 Year 10 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

2019 Year 12 Month 18 Day

Last modified on

2022 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044305


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name