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UMIN-CTR 臨床試験登録情報の閲覧 |
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用語の説明（簡易版） |
用語の説明（詳細版）--準備中 |
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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 |
| 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
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| 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
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| 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
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| 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
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| 試験実施地域/Region |
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| 対象疾患/Condition | |||
| 対象疾患名/Condition | Primary open angle glaucoma (POAG)
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| 疾患区分1/Classification by specialty |
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| 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.
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| 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.
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| 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.
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| 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 |
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| 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. |
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| 介入2/Interventions/Control_2 | Group B without regular chair based stretching exercise (CBSE)
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| 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 |
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| 年齢（上限）/Age-upper limit |
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| 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 |
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| 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 |
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| 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 |
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| 所属組織/Organization | Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.
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| 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 |
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| 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)
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| 機関名/Institute （機関選択不可の場合） |
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| 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)
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| 機関名/Organization （機関選択不可の場合） |
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| 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)
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| 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 |
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| 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 |
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| 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 |
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| 倫理委員会による承認日/Date of IRB |
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| 登録・組入れ開始（予定）日/Anticipated trial start date |
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| フォロー終了(予定)日/Last follow-up date |
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| 入力終了(予定)日/Date of closure to data entry |
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| データ固定（予定）日/Date trial data considered complete |
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| 解析終了(予定)日/Date analysis concluded |
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| 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 |
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| 最終更新日/Last modified on |
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| 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 |
