UMIN-CTR Clinical Trial

Public title

Effects of breathing exercises on lung functions and performance in rowers

Acronym

Effects of breathing exercises on lung functions and performance in rowers.

Scientific Title

Effects of a respiratory muscle training program on ventilatory functions, aerobic fitness and performance in professional male rowers in Sri Lanka.

Scientific Title:Acronym

Effects of a RMT on ventilatory functions, aerobic fitness and performance in male rowers in Sri Lanka.

Region

Asia(except Japan)

Condition

Case-controlled randomized study

Classification by specialty

Pneumology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effects of a Respiratory Muscle Training (RMT) program on ventilatory
functions, aerobic fitness and performance in professional male rowers in Sri Lanka
Army.

Basic objectives2

Others

Basic objectives -Others

1. To investigate the effects of a 12-week RMT program on ventilatory functions (PIFR,
PEFR, VC, FVC, FEV1, FEV1 / FVC) in the experimental group compared to the control
group in professional male rowers in Sri Lanka Army.
2. To assess the effects of a 12-week RMT program on Respiratory Muscle Strength (RMS)
and Respiratory Muscle Fatigue (RMF) in the experimental group compared to the
control group in professional male rowers in Sri Lanka Army.

3. To assess the effects of a 12-week RMT program on aerobic fitness and rowing ergometer
performance in the experimental group compared to the control group in professional
male rowers in Sri Lanka Army.

4. To assess and compare the influence of rowing postures on ventilatory parameters,
respiratory muscle strength and respiratory muscle fatigue between the experimental and
the control group after a 12-week training program in professional male rowers in Sri
LankaArmy.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Phase I,II

Primary outcomes

1. Ventilatory functions: PIFR, PEFR, VC, FVC, FEVI and FEV1/FVC (%) Method of assessd: using spirometer (Spiro analyzer ST-75) Time points: (Baseline and 12 weeks) and Respiratory muscle strength: PImax (Inspiratory mouth pressure) and PEmax Expiratory mouth pressure) Method of assessed: using mouth pressure meter (Micro MPM, Micro Medical Ltd., Kent, United Kingdom; Precision Medical MPM, UK) Time points: (Baseline and 12 weeks)

Key secondary outcomes

Aerobic fitness : VO2 max (Volume of maximum oxygen consumption) Method of assessed: using Monark cycle ergometer 828E Time points: (Baseline and 12 weeks) and 2000m and 5000m ergometer performance Method of assessed: using concept II, (Nottingham, UK) ergometer machine Time points: (Baseline and 12 weeks)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Respiratory Muscles Training Program for the Experimental Group

This novel respiratory muscle training program followed by the experimental group included a warm-up session, flexibility training, inspiratory and expiratory muscle strength training programs and warm-down sessions. The respiratory muscle training program was conducted for 7 days per week for 12 weeks.
Warm-Up session: Rowers followed a warm-up exercise session prior to performing the
respiratory muscle training program. This included 10 minutes of running with normal breathing with inspiration through the nose and expiration through mouth.

Flexibility Training
- Full body stretch and (Thomas et al., 2005).
- Lateral stretch (Thomas et al., 2005).

Respiratory Muscle Training
Inspiratory Muscle Training
(I) Diaphragmatic re-education(Porter, 2013)
(II) Profound (Deep) Inspiration(Porter, 2013)
(III) Inspiratory hiccups (Porter, 2013).

Expiratory muscle training
(I) Isometric Side Bridge (Thomas, et al., 2005).
(II) Curl-ups (Thomas et al., 2005).

Warm down session: After the respiratory muscle training program, the rowers followed a
warm-down session. This included 10 minutes of running with normal breathing while inspiring
through the nose and expiring through mouth.

Interventions/Control_2

General Exercise Program for the Control Group
The general exercise program followed by the control group consisted of a warm-up session
(similar to intervention group), flexibility training and strength training programs for non
respiratory muscles such as biceps, triceps, quadriceps and hamstring muscles. The control group
did not receive any intervention for respiratory muscle strength training. This was in addition to
the routine exercise schedule followed during the competition season. This training program was
conducted for 7 days per week for 12 weeks.

Warm-Up session
Rowers in the control group followed the same warm-up session which was followed by the
experimental group. This included 10 minutes of running with normal breathing, inspiration
through the nose and expiration through the mouth.
Flexibility Training
Flexibility training of the control group included the following:
(I) Biceps stretching : (Thomas et al., 2005).
(II) Triceps stretching: (Thomas et al., 2005).
Strength training
In the control group, strength training exercises were included as follows:
(I) Biceps curls : (Thomas, et al., 2005).
(II) Triceps curls: (Thomas et al., 2005).
(III) Hamstring curls : (Thomas et al., 2005).
(IV) Quadriceps strengthening (Straight Leg raises) : Thomas et al., 2005).
Warm down session: Rowers followed a warm down session after the general exercise program.
This included 10 minutes of running with normal breathing After the warm-down session, the
rowers were instructed to stretch all the major muscle groups (biceps, triceps, quadriceps and
hamstring) that were used during the exercise program for 20 to 30 seconds, 2 to 3 times
(Thomas et al., 2005).

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

35

years-old

>=

Gender

Male

Key inclusion criteria

Healthy adult national male rowers and non- smokers.

Key exclusion criteria

1. Participants who were suffering from any respiratory illness at the time of data collection
2. Subjects who were on medication for any illness.

Target sample size

20

Name of lead principal investigator

1st name	Angage
Middle name	Dilani Priyashanthi
Last name	Perera

Organization

General Sir John Kotelawala Defence University

Division name

Wadduwa

Zip code

0094

Address

No 34, Maragahawatta road, Moronthuduwa

TEL

0774935051

Email

dperera85@yahoo.com

Name of contact person

1st name	Angage
Middle name	Dilani Priyashanthi
Last name	Perera

Organization

General Sir John Kotelawala Defence University

Division name

Rathmalana

Zip code

0094

Address

Kandawala road, Rathmalana

TEL

0774935051

Homepage URL

https://www.kdu.ac.lk/

Email

kdudefence@kdu.ac.lk

Institute

General Sir John Kotelawala Defence University

Institute

Department

Personal name

Organization

General Sir John Kotelawala Defence University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Review Committee, Faculty of Medicine, University of Peradeniya

Address

Galaha road, Peradeniya.

Tel

+94812396201

Email

chairpersonierc@gmail.com

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

2020

Year

07

Month

22

Day

URL releasing protocol

https://med.pdn.ac.lk/admin/committees_Ethical.html

Publication of results

Partially published

URL related to results and publications

https://med.pdn.ac.lk/admin/committees_Ethical.html

Number of participants that the trial has enrolled

20

Results

The findings of this study suggest that the novel respiratory muscle training
program had some beneficial effects on selected ventilatory parameters and rowing
performance in professional Army rowers in Sri Lanka. Therefore, it can be concluded that
this novel RMT program would be beneficial in improving respiratory functions,
strengthening the respiratory muscles, improving aerobic fitness and sports performance of Sri
Lankan sportsmen.

Results date posted

2020

Year

05

Month

09

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

In total, 20 male rowers between the ages of 20-35 years were selected from a total population
of 40 from the Sri Lanka Army rowing team using the random number generator. The age,
height and weight matched study population was divided into two groups: an experimental
group (n= 11) and a control group (n= 9).

Participant flow

Data collection was carried out at the General Sir John Kotelawala Defence University and the
Exercise and Sports Science laboratory, Department of Physiology, Faculty of Medicine,
University of Peradeniya. Prior to the commencement of the training program, baseline
measurements and tests namely lung volumes, flow rates and capacities, VO2 max, respiratory
muscle strength including maximal inspiratory (PImax) and maximal expiratory pressures
(PEmax), 2000m and 5000m rowing ergometer time trial were carried out on all 20 subjects
by the principal investigator.

Adverse events

Any information that is obtained in connection with this study and that can be identified with rowers remain confidential and is disclosed only with participants permission, except as required by law. If a rower feels any hazards and discomfort during the research study, he can withdraw his consent to participate in the study at any time.

Outcome measures

Ventilatory functions, respiratory muscle strength, aerobic fitness and rowing ergometrer performance was assess at baseline and at the end of 12 weeks period.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

02

Month

16

Day

Date of IRB

2016

Year

10

Month

20

Day

Anticipated trial start date

2017

Year

02

Month

20

Day

Last follow-up date

2017

Year

05

Month

20

Day

Date of closure to data entry

2017

Year

10

Month

20

Day

Date trial data considered complete

2017

Year

10

Month

20

Day

Date analysis concluded

2018

Year

02

Month

20

Day

Other related information

Registered date

2020

Year

05

Month

09

Day

Last modified on

2020

Year

07

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046022