|一般向け試験名/Public title||Effects of breathing exercises on lung functions and performance in rowers|
|一般向け試験名略称/Acronym||Effects of breathing exercises on lung functions and performance in rowers.|
|科学的試験名/Scientific Title||Effects of a respiratory muscle training program on ventilatory functions, aerobic fitness and performance in professional male rowers in Sri Lanka.|
|科学的試験名略称/Scientific Title:Acronym||Effects of a RMT on ventilatory functions, aerobic fitness and performance in male rowers in Sri Lanka.|
|対象疾患名/Condition||Case-controlled randomized study|
|疾患区分1/Classification by specialty||
|疾患区分2/Classification by malignancy||悪性腫瘍以外/Others|
|目的1/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
|目的2 -その他詳細/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
|試験のフェーズ/Developmental phase||第Ⅰ・Ⅱ相/Phase I,II|
|主要アウトカム評価項目/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)|
|副次アウトカム評価項目/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)|
|ブラインド化/Blinding||オープン/Open -no one is blinded|
|試験実施施設の考慮/Institution consideration||施設を考慮していない/Institution is not considered as adjustment factor.|
|割付コードを知る方法/Concealment||封筒法/Numbered container method|
|群数/No. of arms||2|
|介入の目的/Purpose of intervention||教育・カウンセリング・トレーニング/Educational,Counseling,Training|
|介入の種類/Type of intervention||
|介入1/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.
- 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.
|介入2/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.
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 of the control group included the following:
(I) Biceps stretching : (Thomas et al., 2005).
(II) Triceps stretching: (Thomas et al., 2005).
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).
|選択基準/Key inclusion criteria|| Healthy adult national male rowers and non- smokers.
|除外基準/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.
|目標参加者数/Target sample size||20|
|責任研究者/Research contact person|
|責任研究者/Name of lead principal investigator||
|所属組織/Organization||General Sir John Kotelawala Defence University|
|住所/Address||No 34, Maragahawatta road, Moronthuduwa|
|試験問い合わせ窓口担当者/Name of contact person||
|組織名/Organization||General Sir John Kotelawala Defence University|
|住所/Address||Kandawala road, Rathmalana|
|機関名/Institute||その他||General Sir John Kotelawala Defence University|
|機関名/Organization||その他||General Sir John Kotelawala Defence University|
|組織の区分/Category of Funding Organization||自己調達/Self funding|
|研究費拠出国/Nationality of Funding Organization|
|その他の関連組織/Other related organizations|
|その他の研究費提供組織/Name of secondary funder(s)|
|IRB等連絡先（公開）/IRB Contact (For public release)|
|組織名/Organization||Ethics Review Committee, Faculty of Medicine, University of Peradeniya|
|住所/Address||Galaha road, Peradeniya.|
|ID発行機関1/Org. issuing International ID_1|
|ID発行機関2/Org. issuing International ID_2|
|治験届/IND to MHLW|
|その他の管理情報/Other administrative information|
|一般公開日（本登録希望日）/Date of disclosure of the study information||
|プロトコル掲載URL/URL releasing protocol||https://med.pdn.ac.lk/admin/committees_Ethical.html|
|試験結果の公開状況/Publication of results||中間解析等の途中公開/Partially published|
|結果掲載URL/URL related to results and publications||https://med.pdn.ac.lk/admin/committees_Ethical.html|
|組み入れ参加者数/Number of participants that the trial has enrolled||20|
|主な結果/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
|主な結果入力日/Results date posted||
|結果遅延理由/Results Delay Reason|
|最初の試験結果の出版日/Date of the first journal publication of results|
|参加者背景/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).
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.
|有害事象/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.|
|評価項目/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.|
|個別症例データ共有計画/Plan to share IPD|
|個別症例データ共有計画の詳細/IPD sharing Plan description|
|プロトコル確定日/Date of protocol fixation||
|倫理委員会による承認日/Date of IRB||
|登録・組入れ開始（予定）日/Anticipated trial start date||
|フォロー終了(予定)日/Last follow-up date||
|入力終了(予定)日/Date of closure to data entry||
|データ固定（予定）日/Date trial data considered complete||
|解析終了(予定)日/Date analysis concluded||
|その他関連情報/Other related information|
|最終更新日/Last modified on||
|閲覧ページへのリンク/Link to view the page|