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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000040345
受付番号 R000046022
科学的試験名
一般公開日(本登録希望日) 2020/07/22
最終更新日 2020/07/22

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
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.
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Case-controlled randomized study
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology リハビリテーション医学/Rehabilitation medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
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
Army.
目的2/Basic objectives2 その他/Others
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
LankaArmy.
試験の性質1/Trial characteristics_1 その他/Others
試験の性質2/Trial characteristics_2 その他/Others
試験のフェーズ/Developmental phase 第Ⅰ・Ⅱ相/Phase I,II

評価/Assessment
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)

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design クロスオーバー試験/Cross-over
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control プラセボ・シャム対照/Placebo
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
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.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
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
その他/Other
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.

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.
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.

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).
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
35 歳/years-old 以下/>=
性別/Gender 男/Male
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

ミドルネーム

Angage
ミドルネーム Dilani Priyashanthi
Perera
所属組織/Organization
General Sir John Kotelawala Defence University
所属部署/Division name
Wadduwa
郵便番号/Zip code 0094
住所/Address
No 34, Maragahawatta road, Moronthuduwa
電話/TEL 0774935051
Email/Email dperera85@yahoo.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Angage
ミドルネーム Dilani Priyashanthi
Perera
組織名/Organization
General Sir John Kotelawala Defence University
部署名/Division name
Rathmalana
郵便番号/Zip code 0094
住所/Address
Kandawala road, Rathmalana
電話/TEL 0774935051
試験のホームページURL/Homepage URL https://www.kdu.ac.lk/
Email/Email kdudefence@kdu.ac.lk

実施責任組織/Sponsor
機関名/Institute その他 General Sir John Kotelawala Defence University
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 General Sir John Kotelawala Defence University
機関名/Organization
(機関選択不可の場合)

組織名/Division
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
共同実施組織/Co-sponsor

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.
電話/Tel +94812396201
Email/Email chairpersonierc@gmail.com

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

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
2020 07 22

関連情報/Related 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/Result
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
Lankan sportsmen.
主な結果入力日/Results date posted
2020 05 09
結果掲載遅延/Results Delayed
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).
参加者の流れ/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.
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


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2016 02 16
倫理委員会による承認日/Date of IRB
2016 10 20
登録・組入れ開始(予定)日/Anticipated trial start date
2017 02 20
フォロー終了(予定)日/Last follow-up date
2017 05 20
入力終了(予定)日/Date of closure to data entry
2017 10 20
データ固定(予定)日/Date trial data considered complete
2017 10 20
解析終了(予定)日/Date analysis concluded
2018 02 20

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 05 09
最終更新日/Last modified on
2020 07 22


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046022
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046022

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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