UMIN-ICDS Clinical Trial

Public title

Effects of Pneumatic Compression Boots and Stretching on Lower-Limb Flexibility and Perceived Fatigue in Healthy University Students

Acronym

IPC and Stretching Study

Scientific Title

Acute Effects of Combined Intermittent Pneumatic Compression and Stretching on Lower-Limb Flexibility and Perceived Fatigue in Healthy University Students: A Randomized Crossover Trial

Scientific Title:Acronym

IPC-FLEX Study

Region

Japan

Condition

Healthy university students

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to compare the immediate effects of stretching alone, intermittent pneumatic compression (IPC) alone, and combined IPC and stretching on knee extension range of motion, perceived fatigue, muscle soreness, and thigh and calf circumferences in healthy male and female university students. Each participant will complete all three conditions in a randomized order, with an interval of at least 7 days between sessions.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Change in right knee extension range of motion (degrees) from immediately before to immediately after each intervention, assessed by manual range-of-motion measurement.

Key secondary outcomes

1. Changes in thigh and calf circumferences (cm) from immediately before to immediately after each intervention, assessed using a 3D body scanner.
2. Change in perceived fatigue from immediately before to immediately after each intervention, assessed using a 100-mm visual analog scale (VAS).
3. Change in muscle soreness from immediately before to immediately after each intervention, assessed using a 100-mm visual analog scale (VAS).

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

Combined IPC-and-stretching condition. Participants will remain in the supine position and receive 20 minutes of intermittent pneumatic compression to both lower limbs using SOMANO Recovery Boots (Montreux Co., Ltd., Japan). The pressure and operating mode will be selected from the device settings before study initiation and standardized across all participants and conditions involving IPC. During IPC, the researcher will administer passive stretching to the hamstrings and gastrocnemius muscles of both lower limbs. Joint positions, stretching intensity, stretching duration, and rest intervals will be identical to those used in the stretching-alone condition.

Interventions/Control_2

Stretching-alone condition. With the participant in the supine position, the researcher will administer passive stretching to the hamstrings and gastrocnemius muscles of both lower limbs for a total of 20 minutes. For the hamstrings, the knee will be passively extended while the hip is maintained at 90 degrees of flexion. For the gastrocnemius, the ankle will be passively dorsiflexed while the hip and knee are maintained at 0 degrees. Stretching intensity will be adjusted according to participant feedback to produce a clear but non-painful stretching sensation. For each muscle group, the right and left legs will each be stretched for 1 minute in succession, followed by a 30-second rest period. One cycle comprising stretching of both the hamstrings and gastrocnemius muscles will last 5 minutes, and four cycles will be performed.

Interventions/Control_3

IPC-alone condition. Participants will remain in the supine position and receive 20 minutes of intermittent pneumatic compression to both lower limbs using SOMANO Recovery Boots (Montreux Co., Ltd., Japan). The pressure and operating mode will be identical to those used in the combined IPC-and-stretching condition. Participants will not perform or receive stretching and will remain at rest in the supine position throughout the intervention.

Interventions/Control_4

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

23

years-old

>=

Gender

Male and Female

Key inclusion criteria

1 University students aged 18 to 23 years enrolled at Niigata University of Health and Welfare
2 Individuals who understand the study and provide written informed consent
3 Individuals who can attend three sessions separated by at least 7 days

Key exclusion criteria

1 Individuals who have sustained a lower-limb injury or developed a lower-limb musculoskeletal disorder within the previous 3 months, or who currently have lower-limb pain severe enough to interfere with the assessments or interventions, swelling, skin lesions, or signs of infection.
2 Individuals with a circulatory disorder or another condition that prevents IPC from being administered safely.
3 Individuals with impaired sensation in the lower limbs or another condition that prevents them from appropriately reporting their responses to pneumatic compression.
4 Individuals judged by the principal investigator, following medical history screening and safety assessment, to be unable to safely complete the assessments or interventions.

Target sample size

30

Name of lead principal investigator

1st name	Akira
Middle name
Last name	Kumazaki

Organization

Niigata University of Health and Welfare

Division name

Department of Health and Sports, Faculty of Health Sciences

Zip code

950-3198

Address

Shimami-cho 1398, Kita-ku, Niigata City, Niigata, Japan

TEL

09060764350

Email

kumazaki@nuhw.ac.jp

Name of contact person

1st name	Akira
Middle name
Last name	Kumazaki

Organization

Niigata University of Health and Welfare

Division name

Department of Health and Sports, Faculty of Health Sciences

Zip code

950-3198

Address

Shimami-cho 1398, Kita-ku, Niigata City, Niigata, Japan

TEL

0252574315

Homepage URL

Email

kumazaki@nuhw.ac.jp

Institute

Niigata University of Health and Welfare

Institute

Department

Personal name

Akira Kumazaki

Organization

Niigata University of Health and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

the Institutional Research Ethics Committee of Niigata University of Health and Welfare

Address

Shimami-cho 1398, Kita-ku, Niigata City, Niigata, Japan

Tel

0252574455

Email

rinri@nuhw.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

新潟医療福祉大学（新潟県）

Date of disclosure of the study information

2026

Year

09

Month

24

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

Preinitiation

Date of protocol fixation

2026

Year

11

Month

20

Day

Date of IRB

Anticipated trial start date

2026

Year

12

Month

01

Day

Last follow-up date

2027

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

09

Month

18

Day

Last modified on

2026

Year

09

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072107