UMIN-CTR 臨床試験登録情報の閲覧

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 11:35:09

※ 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

日本語


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

一般向け試験名略称/Acronym

日本語


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

科学的試験名/Scientific Title

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語
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

日本語


英語

介入4/Interventions/Control_4

日本語


英語

介入5/Interventions/Control_5

日本語


英語

介入6/Interventions/Control_6

日本語


英語

介入7/Interventions/Control_7

日本語


英語

介入8/Interventions/Control_8

日本語


英語

介入9/Interventions/Control_9

日本語


英語

介入10/Interventions/Control_10

日本語


英語


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

日本語


英語
Healthy adult national male rowers and non- smokers.

除外基準/Key exclusion criteria

日本語


英語
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

日本語

ミドルネーム


英語
Angage
ミドルネーム Dilani Priyashanthi
Perera

所属組織/Organization

日本語


英語
General Sir John Kotelawala Defence University

所属部署/Division name

日本語


英語
Wadduwa

郵便番号/Zip code

0094

住所/Address

日本語


英語
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

日本語

ミドルネーム


英語
Angage
ミドルネーム Dilani Priyashanthi
Perera

組織名/Organization

日本語


英語
General Sir John Kotelawala Defence University

部署名/Division name

日本語


英語
Rathmalana

郵便番号/Zip code

0094

住所/Address

日本語


英語
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


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
その他


英語
General Sir John Kotelawala Defence University

機関名/Institute
(機関選択不可の場合)

日本語


部署名/Department

日本語


個人名/Personal name

日本語


英語


研究費提供組織/Funding Source

機関名/Organization

日本語
その他


英語
General Sir John Kotelawala Defence University

機関名/Organization
(機関選択不可の場合)

日本語


組織名/Division

日本語


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

日本語


英語


その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語


英語

その他の研究費提供組織/Name of secondary funder(s)

日本語


英語


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語


英語
Ethics Review Committee, Faculty of Medicine, University of Peradeniya

住所/Address

日本語


英語
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

日本語


英語

試験ID2/Study ID_2


ID発行機関2/Org. issuing International ID_2

日本語


英語

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

日本語


英語
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

日本語


英語

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

日本語


英語
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

日本語


英語

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

日本語


英語
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

日本語


英語
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

日本語


英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語


英語


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

日本語


英語


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

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046022


英語
https://center6.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