UMIN-ICDS Clinical Trial

Public title

A Study of the Effects of Rowing Exercise with Breathing Resistance in Competitive Rowers

Acronym

A Study of the Effects of Rowing Exercise with Breathing Resistance in Competitive Rowers

Scientific Title

Effects of Respiratory Loading During Rowing Ergometer Training in Competitive Rowers: A Pilot Study Using a Multiple-Baseline Design

Scientific Title:Acronym

Effects of Respiratory Loading During Rowing Ergometer Training in Competitive Rowers: A Pilot Study Using a Multiple-Baseline Design

Region

Japan

Condition

Adult competitive rowers

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore the effects of concurrent rowing ergometer exercise and respiratory loading using ReBNA on maximal oxygen uptake, the first ventilatory threshold, respiratory muscle function, pulmonary function, and rowing performance in competitive rowers using a multiple-baseline single-case experimental design.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Maximal oxygen uptake (VO2max)
Assessed during an incremental exercise test on a Concept2 rowing ergometer using a Cpex-1 metabolic measurement system. The highest VO2 is determined using a 30-second moving average. When a VO2 plateau is not confirmed, VO2peak is recorded, and maximal effort is assessed using the additional criteria specified in the study protocol.

2. First ventilatory threshold (VT1; gas exchange threshold, GET)
Determined using the V-slope method, supported by the ventilatory equivalents method. Oxygen uptake, power output, and minute ventilation at VT1 are assessed. Two blinded assessors independently determine VT1. Disagreements are resolved by discussion or, if unresolved, by a third assessor.

Assessments are performed twice during baseline and once after the 6-week intervention.

Key secondary outcomes

1. Rowing performance: completion time, mean power output, and total distance in a 2,000-m rowing ergometer time trial.
2. Respiratory muscle strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
3. Pulmonary function: forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF).
4. Physiological responses during incremental exercise: minute ventilation, ventilatory equivalents for oxygen and carbon dioxide, respiratory exchange ratio, respiratory rate, and peak heart rate.
5. Subjective responses: rating of perceived exertion using the Borg CR-10 scale and dyspnea visual analogue scale.
6. Rowing technique: stroke rate, distance per stroke, and power output.
7. Intervention load and adherence: session RPE, dyspnea rating, exercise heart rate, and adherence.
8. Safety: occurrence of adverse events.

University-based assessments are performed twice during baseline and once after the intervention. Pulmonary function and respiratory muscle strength are also assessed weekly during the intervention. Training load, adherence, and symptoms are recorded in a diary for each intervention session.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

This is a multiple-baseline single-case experimental study across participants. Baseline duration varies across participants, with staggered introduction of the intervention. Each participant undergoes two baseline assessments and one post-intervention assessment. No separate control group is included; within-participant baseline and post-intervention findings are compared. Participants and intervention providers are not blinded. Two assessors independently determine the first ventilatory threshold under blinded conditions.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Members of the Toda Chuo General Hospital Rowing Club who regularly undertake rowing training with the aim of competing in rowing events.
2. Aged 20 years or older at the time of study participation.
3. At recruitment, have undertaken rowing ergometer and on-water training at least three times per week for at least three consecutive months.
4. Self-report no physician-imposed restrictions or contraindications to the exercise intensity and respiratory loading used in this study.

Written informed consent is obtained voluntarily before participation.

Key exclusion criteria

1. Physician-imposed restrictions or contraindications regarding exercise intensity.
2. A history of respiratory, cardiovascular, or other conditions that the principal investigator judges would increase health risks during exercise with respiratory loading.
3. Pregnancy, breastfeeding, or possible pregnancy.
4. A direct relationship of interest with the principal investigator or other investigators that could influence the decision to participate, including employment, personnel evaluation, or academic grading.

Target sample size

4

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Kido

Organization

Saitama Prefectural University

Division name

Department of Physical Therapy, School of Health and Social Services

Zip code

343-8540

Address

820 Sannomiya, Koshigaya, Saitama 343-8540, Japan

TEL

0489734173

Email

stkido@gmail.com

Name of contact person

1st name	Satoshi
Middle name
Last name	Kido

Organization

Saitama Prefectural University

Division name

Department of Physical Therapy, School of Health and Social Services

Zip code

343-8540

Address

820 Sannomiya, Koshigaya, Saitama 343-8540, Japan

TEL

0489734173

Homepage URL

Email

kido-satoshi@spu.ac.jp

Institute

Saitama Prefectural University

Institute

Department

Personal name

Satoshi Kido

Organization

Saitama Prefectural University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Saitama Prefectural University

Address

820 Sannomiya, Koshigaya, Saitama 343-8540, Japan

Tel

0489734173

Email

kido-satoshi@spu.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

09

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

09

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

10

Day

Last follow-up date

2027

Year

02

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

11

Month

08

Day

Last modified on

2026

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072737