UMIN-ICDS Clinical Trial

Public title

A Study on the Effects of Heat Therapy and Stretching on Body Flexibility

Acronym

Effects of Heat Therapy and Stretching on Flexibility

Scientific Title

Effects of Thermotherapy and Stretching on Soft Tissue Extensibility

Scientific Title:Acronym

Thermotherapy and Stretching for Soft Tissue Extensibility

Region

Japan

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Limited range of motion (ROM) is a common functional impairment that significantly hinders daily living. Its causes are extremely diverse, ranging from soft tissues surrounding the joint, such as the skin, skeletal muscles, and joint capsule, to joint components such as bone and cartilage. ROM restrictions rank among the top three conditions treated in physical therapy and are a critical functional impairment that must be addressed in the field of rehabilitation (Japan Association of Physical Therapists, 1990-2010).
The causes of ROM restrictions that can be expected to improve through conservative treatments such as physical therapy are related to the soft tissues surrounding the joints (Okita, 2014). Treatment strategies include physical therapy centered on heat therapy and exercise therapy, such as stretching. Previous studies have shown that heat therapy and stretching are effective in improving the extensibility of soft tissues (Harvey et al., 2017; Nakano et al., 2012). However, for both treatment methods, there has not yet been sufficient verification of factors such as the optimal duration and frequency required to maximize their effectiveness.
Therefore, the purpose of this study is to verify the optimal methods of heat therapy and stretching to improve soft tissue extensibility.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

range of motion (Before and After Intervention)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Sham Treatment

Interventions/Control_2

Thermal therapy
Duration: 1-30 minutes
Frequency: 1-5 times per week for 1-3 weeks

Interventions/Control_3

Stretching
Duration: 10-60 seconds
Frequency: 1-5 times per set, 1-5 times per week for 1-3 weeks

Interventions/Control_4

Thermal therapy + Stretching

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Participants must be able-bodied individuals aged 18 or older who, after receiving an oral and written explanation of the purpose and methods of the study, as well as the risks and lack of compensation associated with participation, have provided written consent indicating their voluntary participation.

Key exclusion criteria

Individuals who report severe pain that interferes with daily life, those with typical physical disabilities caused by conditions such as cerebrovascular disease or rheumatoid arthritis, and those with a history of fractures or other conditions in the upper extremities resulting in joint fusion are excluded.

Target sample size

72

Name of lead principal investigator

1st name	Kenichiro
Middle name
Last name	Miyahara

Organization

Hokuriku University

Division name

Faculty of health and medical sciences

Zip code

9201180

Address

1-1 Taiyogaoka, Kanazawa

TEL

076291161

Email

k-miyahara@hokuriku-u.ac.jp

Name of contact person

1st name	Kenichiro
Middle name
Last name	Miyahara

Organization

Hokuriku University

Division name

Faculty of health and medical sciences

Zip code

9201180

Address

1-1 Taiyogaoka, Kanazawa

TEL

0762291161

Homepage URL

Email

k-miyahara@hokuriku-u.ac.jp

Institute

Hokuriku University

Institute

Department

Personal name

Kenichiro Miyahara

Organization

Hokuriku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Hokuriku University

Address

1-1 Taiyogaoka, Kanazawa

Tel

0762291161

Email

k-miyahara@hokuriku-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2025

Year

12

Month

25

Day

Date of IRB

2025

Year

12

Month

25

Day

Anticipated trial start date

2025

Year

12

Month

25

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

11

Month

10

Day

Last modified on

2026

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072758