UMIN-CTR 臨床試験登録情報の閲覧

UMIN試験ID UMIN000042637
受付番号 R000048487
科学的試験名
一般公開日(本登録希望日) 2020/12/06
最終更新日 2020/12/05 16:12:44

※ 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
A STUDY ON LONG TERM EFFECT OF CHAIR BASED STRETCHING EXERCISE ON THE INTRAOCULAR PRESSURE AND QUALITY OF LIFE IN PRIMARY OPEN ANGLE GLAUCOMA PATIENTS

一般向け試験名略称/Acronym

日本語


英語
A STUDY ON LONG TERM EFFECT OF CBSE ON THE IOP AND QoL IN POAG

科学的試験名/Scientific Title

日本語


英語
A STUDY ON LONG TERM EFFECT OF CHAIR BASED STRETCHING EXERCISE ON THE INTRAOCULAR PRESSURE AND QUALITY OF LIFE IN PRIMARY OPEN ANGLE GLAUCOMA PATIENTS

科学的試験名略称/Scientific Title:Acronym

日本語


英語
A STUDY ON LONG TERM EFFECT OF CBSE ON THE IOP AND QoL IN POAG

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
Primary open angle glaucoma (POAG)

疾患区分1/Classification by specialty

眼科学/Ophthalmology

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 evaluate the long term effect of chair based stretching exercise on the intraocular pressure (IOP) and quality of life (QoL) among primary open angle glaucoma (POAG) patients.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語


英語

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

その他/Others

試験のフェーズ/Developmental phase

該当せず/Not applicable


評価/Assessment

主要アウトカム評価項目/Primary outcomes

日本語


英語
Intraocular pressure (IOP) measurement. IOP was taken at baseline, 3 months, 6 months, 9 months and one year.

副次アウトカム評価項目/Key secondary outcomes

日本語


英語
Quality of life (QoL) evaluation. QoL was evaluated at baseline and one year.


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

並行群間比較/Parallel

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

介入実施者・測定者がブランド化されている単盲検/Single blind -investigator(s) and assessor(s) are blinded

コントロール/Control

無治療対照/No treatment

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

治療・ケア/Treatment

介入の種類/Type of intervention

その他/Other

介入1/Interventions/Control_1

日本語


英語
Group A with regular chair based stretching exercise (CBSE).

The CBSE comprised 10 different types of stretching movements of upper and lower limb muscles. The exercise regime was as follows:

a. The completion of one cycle of 10 different types of stretching movements of upper and lower limbs muscles is considered as 1 set of exercise. Each day the patient was asked to complete 2 sets of the exercise, this was considered as a session of exercise for that day. Patients were required to complete five sessions of exercise per week. The intensity of the exercise was individualised according to their baseline fitness level. It was aimed for low to moderate intensity of exercise for the elderly. Certain type of stretching movement has its own number of repetitions of movement to be performed. There were rest stations in between the 10 different types of stretching movements. One minute rest was allocated in between the different types of stretching movements. Patients were asked to perform the first set of exercise at 0800 and another set at 1600. Patients were told to complete the two sets of exercise regime between 30 minutes to 60 minutes per day.

介入2/Interventions/Control_2

日本語


英語
Group B without regular chair based stretching exercise (CBSE)

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


適用なし/Not applicable

年齢(上限)/Age-upper limit

50 歳/years-old 以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語


英語
1. Confirmed cases of primary open angle glaucoma (POAG)
2. Age 50 years and above
3. Good compliance with intraocular pressure (IOP) lowering agents

除外基準/Key exclusion criteria

日本語


英語
1. Patients who were known to have habitual regular exercise
2. Patients who drink coffee frequently
3. Active smoker
4. History of previous intraocular surgery other than uncomplicated cataract surgery including trabeculectomy and glaucoma drainage device implantation
5. Patients with unilateral or bilateral absolute glaucoma.
6. History of ocular trauma
7. History of uveitis
8. Ocular and systemic diseases affecting the visual fields (such as diabetic retinopathy, retinal vein occlusion, ischemic optic neuropathy, stroke and ocular media opacities)
9. Physically incapable of doing physical exercise (such as amputated limbs, and body paralysis)
10. Uncontrolled diabetes mellitus
11. Known case of recent ischemic heart disease

目標参加者数/Target sample size

60


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
Sylves
ミドルネーム Bin
Patrick

所属組織/Organization

日本語


英語
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.

所属部署/Division name

日本語


英語
Surgical Based Department

郵便番号/Zip code

88400

住所/Address

日本語


英語
Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia

電話/TEL

+60105093168

Email/Email

sylves@ums.edu.my


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
Sylves
ミドルネーム Bin
Patrick

組織名/Organization

日本語


英語
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.

部署名/Division name

日本語


英語
Surgical Based Department

郵便番号/Zip code

88400

住所/Address

日本語


英語
Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia

電話/TEL

+60105093168

試験のホームページURL/Homepage URL


Email/Email

sylves@ums.edu.my


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
Hospital Universiti Sains Malaysia (HUSM)

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
Hospital Universiti Sains Malaysia (HUSM)

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

海外/Outside Japan

研究費拠出国/Nationality of Funding Organization

日本語


英語
Malaysian


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
Human Research Ethic Committee USM (HREC)

住所/Address

日本語


英語
Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia

電話/Tel

(6)09-7673000 ext 2354/2362

Email/Email

jepem@usm.my


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

Hospital Universiti Sains Malaysia (HUSM)(Kubang Kerian)


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 12 06


関連情報/Related information

プロトコル掲載URL/URL releasing protocol

https://drive.google.com/drive/folders/1tutQj3kiSec1xxkPaxGZwKasMNkzf4ON?usp=sharing

試験結果の公開状況/Publication of results

未公表/Unpublished


結果/Result

結果掲載URL/URL related to results and publications

https://drive.google.com/drive/folders/1tutQj3kiSec1xxkPaxGZwKasMNkzf4ON?usp=sharing

組み入れ参加者数/Number of participants that the trial has enrolled

60

主な結果/Results

日本語


英語
There was a reducing trend of IOP even though the baseline IOP was higher in group A. On the comparison between group A and group B, there was no significant statistical difference of IOP (p = 0.958). In general, there was no significant difference in QoL between the two groups at 12 months post-exercise (p = 0.739). There was an improvement of QoL domain for anxiety at 12 months post-CBSE in group A (P = 0.007). However, other domains had no significant improvements.

主な結果入力日/Results date posted

2020 12 02

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
A total of 60 POAG patients participated in this study. There were more men in both groups. Hypertension was the most common systemic comorbidities in both groups. There was no significant difference in demographic data at baseline between both groups. A majority of POAG patients were on at least two IOP lowering drugs in both groups. However, no significant difference between the two groups in HVF parameters, optic nerve parameter, the number of IOP lowering drugs and AGIS score.

参加者の流れ/Participant flow

日本語


英語
The total number of POAG patients who were assessed during the study was 92 patients. A total number of 32 patients were excluded from the study; 25 patients did not meet the inclusion and exclusion criteria, and 7 patients declined to participate in the study. Only 60 patients were eligible; 30 in group A and 30 in group B. One POAG patient in group A had been withdrawn at three months follow-up due to failure to adhere to the exercise regime.

有害事象/Adverse events

日本語


英語
There was no adverse event reported throughout this study.

評価項目/Outcome measures

日本語


英語
There was a reducing trend of IOP even though the baseline IOP was higher in group A. On the comparison between group A and group B, there was no significant statistical difference of IOP (p = 0.958). In general, there was no significant difference in QoL between the two groups at 12 months post-exercise (p = 0.739). There was an improvement of QoL domain for anxiety at 12 months post-CBSE in group A (P = 0.007). However, other domains had no significant improvements.

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

2017 07 28

倫理委員会による承認日/Date of IRB

2017 08 28

登録・組入れ開始(予定)日/Anticipated trial start date

2017 09 01

フォロー終了(予定)日/Last follow-up date

2019 01 31

入力終了(予定)日/Date of closure to data entry

2019 02 28

データ固定(予定)日/Date trial data considered complete

2019 03 31

解析終了(予定)日/Date analysis concluded

2019 04 30


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 12 03

最終更新日/Last modified on

2020 12 05



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=R000048487


英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048487


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