UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042637 |
|---|---|
| Receipt number | R000048487 |
| 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 |
| Date of disclosure of the study information | 2020/12/06 |
| Last modified on | 2020/12/05 16:12:44 |
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Basic information
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
Acronym
A STUDY ON LONG TERM EFFECT OF CBSE ON THE IOP AND QoL IN POAG
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
Scientific Title:Acronym
A STUDY ON LONG TERM EFFECT OF CBSE ON THE IOP AND QoL IN POAG
Region
| Asia(except Japan) |
Condition
Condition
Primary open angle glaucoma (POAG)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular pressure (IOP) measurement. IOP was taken at baseline, 3 months, 6 months, 9 months and one year.
Key secondary outcomes
Quality of life (QoL) evaluation. QoL was evaluated at baseline and one year.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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.
Interventions/Control_2
Group B without regular chair based stretching exercise (CBSE)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
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
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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sylves |
| Middle name | Bin |
| Last name | Patrick |
Organization
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.
Division name
Surgical Based Department
Zip code
88400
Address
Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia
TEL
+60105093168
sylves@ums.edu.my
Public contact
Name of contact person
| 1st name | Sylves |
| Middle name | Bin |
| Last name | Patrick |
Organization
Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah.
Division name
Surgical Based Department
Zip code
88400
Address
Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia
TEL
+60105093168
Homepage URL
sylves@ums.edu.my
Sponsor or person
Institute
Hospital Universiti Sains Malaysia (HUSM)
Institute
Department
Personal name
Funding Source
Organization
Hospital Universiti Sains Malaysia (HUSM)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Malaysian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethic Committee USM (HREC)
Address
Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia
Tel
(6)09-7673000 ext 2354/2362
jepem@usm.my
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Hospital Universiti Sains Malaysia (HUSM)(Kubang Kerian)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
https://drive.google.com/drive/folders/1tutQj3kiSec1xxkPaxGZwKasMNkzf4ON?usp=sharing
Publication of results
Unpublished
Result
URL related to results and publications
https://drive.google.com/drive/folders/1tutQj3kiSec1xxkPaxGZwKasMNkzf4ON?usp=sharing
Number of participants that the trial has enrolled
60
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.
Results date posted
| 2020 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
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.
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.
Adverse events
There was no adverse event reported throughout this study.
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.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 03 | Day |
Last modified on
| 2020 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048487
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