UMIN試験ID | UMIN000042637 |
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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 |
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
日本語
英語
A STUDY ON LONG TERM EFFECT OF CBSE ON THE IOP AND QoL IN POAG
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
日本語
英語
A STUDY ON LONG TERM EFFECT OF CBSE ON THE IOP AND QoL IN POAG
アジア(日本以外)/Asia(except Japan) |
日本語
英語
Primary open angle glaucoma (POAG)
眼科学/Ophthalmology |
悪性腫瘍以外/Others
いいえ/NO
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.
有効性/Efficacy
日本語
英語
探索的/Exploratory
その他/Others
該当せず/Not applicable
日本語
英語
Intraocular pressure (IOP) measurement. IOP was taken at baseline, 3 months, 6 months, 9 months and one year.
日本語
英語
Quality of life (QoL) evaluation. QoL was evaluated at baseline and one year.
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
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
無治療対照/No treatment
いいえ/NO
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
いいえ/NO
封筒法/Numbered container method
2
治療・ケア/Treatment
その他/Other |
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.
日本語
英語
Group B without regular chair based stretching exercise (CBSE)
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
適用なし/Not applicable |
50 | 歳/years-old | 以下/>= |
男女両方/Male and Female
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
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
60
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | Sylves |
ミドルネーム | Bin |
姓 | Patrick |
日本語
英語
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.
日本語
英語
Surgical Based Department
88400
日本語
英語
Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia
+60105093168
sylves@ums.edu.my
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | Sylves |
ミドルネーム | Bin |
姓 | Patrick |
日本語
英語
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.
日本語
英語
Surgical Based Department
88400
日本語
英語
Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia
+60105093168
sylves@ums.edu.my
日本語
その他
英語
Hospital Universiti Sains Malaysia (HUSM)
日本語
日本語
日本語
英語
日本語
その他
英語
Hospital Universiti Sains Malaysia (HUSM)
日本語
日本語
海外/Outside Japan
日本語
英語
Malaysian
日本語
英語
日本語
英語
日本語
英語
Human Research Ethic Committee USM (HREC)
日本語
英語
Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia
(6)09-7673000 ext 2354/2362
jepem@usm.my
いいえ/NO
日本語
英語
日本語
英語
Hospital Universiti Sains Malaysia (HUSM)(Kubang Kerian)
2020 | 年 | 12 | 月 | 06 | 日 |
https://drive.google.com/drive/folders/1tutQj3kiSec1xxkPaxGZwKasMNkzf4ON?usp=sharing
未公表/Unpublished
https://drive.google.com/drive/folders/1tutQj3kiSec1xxkPaxGZwKasMNkzf4ON?usp=sharing
60
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.
2020 | 年 | 12 | 月 | 02 | 日 |
日本語
英語
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.
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.
日本語
英語
There was no adverse event reported throughout this study.
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.
日本語
英語
日本語
英語
試験終了/Completed
2017 | 年 | 07 | 月 | 28 | 日 |
2017 | 年 | 08 | 月 | 28 | 日 |
2017 | 年 | 09 | 月 | 01 | 日 |
2019 | 年 | 01 | 月 | 31 | 日 |
2019 | 年 | 02 | 月 | 28 | 日 |
2019 | 年 | 03 | 月 | 31 | 日 |
2019 | 年 | 04 | 月 | 30 | 日 |
日本語
英語
2020 | 年 | 12 | 月 | 03 | 日 |
2020 | 年 | 12 | 月 | 05 | 日 |
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
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