UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040345
Receipt No. R000046022
Scientific Title Effects of a respiratory muscle training program on ventilatory functions, aerobic fitness and performance in professional male rowers in Sri Lanka.
Date of disclosure of the study information 2020/07/22
Last modified on 2020/07/22 (Ver. 3)

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Basic information
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
Condition Case-controlled randomized study
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute General Sir John Kotelawala Defence University
Institute
Department

Funding Source
Organization General Sir John Kotelawala Defence University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Address Galaha road, Peradeniya.
Tel +94812396201
Email chairpersonierc@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 22 Day

Related information
URL releasing protocol https://med.pdn.ac.lk/admin/committees_Ethical.html
Publication of results Partially published

Result
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

Progress
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
Other related information

Management information
Registered date
2020 Year 05 Month 09 Day
Last modified on
2020 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046022