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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 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

※ 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
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
A STUDY ON LONG TERM EFFECT OF CBSE ON THE IOP AND QoL IN POAG
科学的試験名/Scientific Title
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
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
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
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

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
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
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
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
Group B without regular chair based stretching exercise (CBSE)
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

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
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
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

ミドルネーム

Sylves
ミドルネーム Bin
Patrick
所属組織/Organization
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.
所属部署/Division name
Surgical Based Department
郵便番号/Zip code 88400
住所/Address
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

ミドルネーム

Sylves
ミドルネーム Bin
Patrick
組織名/Organization
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.
部署名/Division name
Surgical Based Department
郵便番号/Zip code 88400
住所/Address
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

実施責任組織/Sponsor
機関名/Institute その他 Hospital Universiti Sains Malaysia (HUSM)
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 Hospital Universiti Sains Malaysia (HUSM)
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 海外/Outside Japan
研究費拠出国/Nationality of Funding Organization
Malaysian

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
Human Research Ethic Committee USM (HREC)
住所/Address
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

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 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
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

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
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
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
There was no adverse event reported throughout this study.
評価項目/Outcome measures
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

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
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


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
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048487
URL(英語) https://upload.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


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