UMIN-ICDS Clinical Trial

Public title

A Study of Arm Exercises Combined with Abdominal Drawing-In Exercises in Adults Who Spend Long Periods Sitting

Acronym

Study of Arm Exercises Combined with Abdominal Drawing-In Exercises in Adults with Prolonged Sitting Time

Scientific Title

Effects of Upper Limb Exercises Combined with the Abdominal Drawing-In Maneuver on Neuromuscular Control, Transversus Abdominis Characteristics, and Respiratory Function in Adults with Prolonged Sitting Time

Scientific Title:Acronym

Effects of ADIM-Combined Upper Limb Exercises in Adults with Prolonged Sitting Time

Region

Japan

Condition

Prolonged Sitting

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Prolonged sitting may be associated with reduced deep trunk muscle activity and altered lumbar spine control. The transversus abdominis (TrA) contributes to spinal stability, and the abdominal drawing-in maneuver (ADIM) is commonly used to activate the deep abdominal muscles. Seated upper limb exercises are simple and practical, but the effects of combining these exercises with ADIM on trunk function and respiratory function remain unclear.

This study aims to investigate the effects of 6 weeks of seated upper limb exercises combined with ADIM in healthy adults who sit for at least 8 hours per day. Participants will be randomly assigned to an ADIM-combined upper limb exercise group or an upper limb exercise control group. The intervention group will perform upper limb exercises while maintaining ADIM with visual feedback from a Pressure Biofeedback Unit (PBU), whereas the control group will perform the same exercises without ADIM.

Before and after the intervention, lumbar movement variability, TrA thickness, TrA shear modulus, and respiratory function, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the FEV1/FVC ratio, will be assessed.

This study will examine the potential benefits of ADIM in adults who spend prolonged periods sitting but have no clinical symptoms. By evaluating spinal movement, TrA characteristics, and respiratory function, the findings may provide evidence for developing simple and practical exercise interventions for this population.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

lumbar movement variability, TrA thickness measured by ultrasound, TrA shear modulus measured by shear-wave elastography, and respiratory function, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the FEV1/FVC ratio.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

The ADIM-combined upper limb exercise group will perform seated upper limb exercises for 30 minutes per session, three times per week for 6 weeks. The intervention will consist of one supervised session and two home exercise sessions per week. Participants will perform upper limb elevation and forward-reaching exercises while maintaining the abdominal drawing-in maneuver (ADIM), using visual feedback from a Pressure Biofeedback Unit (PBU) to support trunk stabilization.

Interventions/Control_2

The upper limb exercise group will perform seated upper limb exercises for 30 minutes per session, three times per week for 6 weeks. The intervention will consist of one supervised session and two home exercise sessions per week. Participants will perform upper limb elevation and forward-reaching exercises while maintaining trunk stability. The abdominal drawing-in maneuver (ADIM) will not be performed.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

45

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Adults aged 20-45 years.

2) Healthy adults whose average sitting time on weekdays over the past 2 months is at least 8 hours per day, including time spent studying, doing desk work, and using a computer.

3) Individuals who currently have no apparent musculoskeletal symptoms, such as low back pain, neck pain, or lower limb pain, that interfere with daily activities.

4) Individuals who have received a sufficient explanation of the purpose, methods, potential benefits, and risks of the study, understand the study procedures, and provide written informed consent.

Key exclusion criteria

1. Individuals with a history of surgery involving the spine or lower limbs.
2. Individuals who have experienced an episode of acute low back pain within the past 6 months.
3. Individuals currently diagnosed by a physician with a lumbar disorder who are receiving treatment or undergoing medical follow-up.
4. Individuals who currently have symptoms such as pain, numbness, or restricted movement that the principal investigator considers likely to interfere with exercise participation.
5. Individuals with neurological disorders, including cerebrovascular disorders or neuromuscular diseases.
6. Individuals with respiratory or cardiovascular diseases for which a physician has instructed them to restrict exercise.
7. Individuals who are pregnant or within 6 months postpartum.
8. Individuals whom the principal investigator otherwise considers unsuitable for participation in this study.

Target sample size

36

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Tajika

Organization

Gunma University Graduate School Of health Sciences

Division name

Rehabilitation

Zip code

3718514

Address

3-39-22 Showa-machi, Maebashi-shi, Gunma, Japan

TEL

027-220-8945

Email

tajika@gunma-u.ac.jp

Name of contact person

1st name	Tsuyoshi
Middle name
Last name	Tajika

Organization

Gunma University Graduate School Of health Sciences

Division name

Rehabilitation

Zip code

3718514

Address

3-39-22 Showa-machi, Maebashi-shi, Gunma, Japan

TEL

027-220-8945

Homepage URL

Email

tajika@gunma-u.ac.jp

Institute

Gunma University

Institute

Department

Personal name

Organization

Next generation Gunma Induction Doctoral Programme for Social Innovation Relay(Next-GIP)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma University Ethical Review Board for Medical Research Involving Human Subjects

Address

15-39-22 Showa-machi, Maebashi-shi, Gunma, Japan

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-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

01

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

09

Month

29

Day

Date of IRB

2026

Year

10

Month

19

Day

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2027

Year

06

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

22

Day

Last modified on

2026

Year

10

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072544