- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07733388
The Effectiveness Of Home-Based Circuit Training On Eye Pressure And Eye Nerve Structures In Patients With Glaucoma
The Effectiveness Of Home-Based Circuit Training On Intraocular Pressure, Retinal Nerve Fiber Layers And Choroidal Thickness In Patients With Glaucoma
The goal of this randomised control trial is to learn about the effect of home based circuit training on patients with primary glaucoma.
The main questions to answer are:
- Is there any difference of intraocular pressure (IOP) in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?
- Is there any difference of retina nerve fibre layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?
- Is there any difference of choroidal thickness layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?
Researchers will compare patients with primary glaucoma who are performing home-based circuit training and not performing home-based circuit training to see if any affect to intraocular pressure, retina nerve fibre layer and choroidal thickness.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Glaucoma is the leading cause of irreversible blindness worldwide. According to a study, it is known that East Asia has the highest number of people with glaucoma (25.20 million), followed by South- Central Asia (17.06 million) and South East Asia (6.92 million). The global prevalence of glaucoma especially in people aged 40 to 80 years is estimated to be 3.5%. The most important risk factor for glaucoma is aging. With the growing number and proportion of older population, it is projected that 111.8 million people will have glaucoma in 2040. The degeneration of retinal ganglion cells (RGCs) and their axons result in an irreversible loss of vision that has a strong correlation with increasing age. The relationship between exercise and glaucoma is complex as various components of physical activity such as fluctuations in blood pressure, body posture, and Valsalva manoeuvres can influence intraocular pressure (IOP) and ocular perfusion pressure, both of which may play roles in glaucoma pathophysiology.
The investigator would like to evaluate the effect of 12 weeks home-based circuit training on intraocular pressure (IOP), retinal nerve fibre layer thickness (RNFL) and choroidal thickness in patients with primary glaucoma. This is a randomised controlled study involving primary glaucoma patients who are attending ophthalmology clinic at Hospital Universiti Sains Malaysia. Evaluation of study sample includes baseline ocular examination, IOP and Optical Coherence Tomography Retinal Nerve Fibre Layer (OCT RNFL) and sub foveal choroidal thickness. Subjects who fulfil the inclusion and exclusion criteria for the study will be selected.
Patients in Group A will perform home-based circuit training for 12 weeks while other Group B (control group) will not perform home-based circuit training. IOP, OCT RNFL and choroidal thickness measurement will be taken at baseline, 6 weeks and 12 weeks post recruitment of subjects. All patients will be given exercise diary to note down their exercise adherence.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: THARANI ELUMALAI, MBBS
- Telefoonnummer: +60123789645
- E-mail: tharanicrystaline93@gmail.com
Studie Locaties
-
-
Kelantan
-
Kubang Kerian, Kelantan, Maleisië, 16150
- Universiti Sains Malaysia
-
Contact:
- THARANI ELUMALAI, MBBS
- Telefoonnummer: 0123789645
- E-mail: tharanicrystaline93@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Age ≥ 18 - 70 years old
- Known case of POAG, PACG, JOAG, NTG
- Phakic without visually significant cataract
- Pseudophakic for more than 3 months prior to recruitment
- Achieved target IOP
- Physically not performing routine exercises
Exclusion Criteria:
- Bilateral eye visual acuity of less than 6/60
- Bilateral eye visual field defect of less than 10 degrees from fixation
- Patient with media opacities that affect the reliability of OCT measurements such as cornea opacity, dense cataract with Lens opacification classification system (LOCS III) of more than grade 2, vitreous haemorrhage
- Patient who underwent intraocular surgery (other than uncomplicated cataract surgery), including anti-vascular endothelial growth factor injection within past 6 months
- Ocular disease such as cornea ulcer, uveitis, age-related macula degeneration
- Physical disabilities such as stroke, limbs amputation
- Uncontrolled systemic diseases eg diabetes, hypertension
- Morbid Obesity (BMI > 40)
- Dementia or any psychiatric diseases
- Smoking
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Home-Based Circuit Training
Patients in Group A will be performing home-based circuit training three times per week for 12 weeks.
|
Participants assigned to the intervention group will perform a home-based circuit training program in addition to receiving standard glaucoma care.
The exercise program consists of seven home-based exercises, including two aerobic exercises and five resistance-based exercises performed in a circuit format.
Each session will last 30 minutes for week 1-6 and 60 minutes for week 7-12.
It is performed three times per week on alternate days for 12 weeks, and is conducted at moderate intensity.
Participants will continue their prescribed glaucoma medications throughout the study.
|
|
Geen tussenkomst: Control Group
Patients in Group B will not will be performing
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Intraocular pressure
Tijdsspanne: Baseline, at 6 weeks and at 12 weeks
|
Baseline, at 6 weeks and at 12 weeks
|
|
Retinal Nerve Fiber Layer
Tijdsspanne: Baseline, at 6 weeks and at 12 weeks
|
Baseline, at 6 weeks and at 12 weeks
|
|
Choroidal Thickness
Tijdsspanne: Baseline, at 6 weeks and at 12 weeks
|
Baseline, at 6 weeks and at 12 weeks
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Zhu MM, Lai JSM, Choy BNK, Shum JWH, Lo ACY, Ng ALK, Chan JCH, So KF. Physical exercise and glaucoma: a review on the roles of physical exercise on intraocular pressure control, ocular blood flow regulation, neuroprotection and glaucoma-related mental health. Acta Ophthalmol. 2018 Sep;96(6):e676-e691. doi: 10.1111/aos.13661. Epub 2018 Jan 16.
- Gonzalez-Devesa D, Suarez-Iglesias D, Diz JC, Esmerode-Iglesias A, Ayan C. Systematic review on the impact of exercise on intraocular pressure in glaucoma patients. Int Ophthalmol. 2024 Aug 19;44(1):351. doi: 10.1007/s10792-024-03216-4.
- Anderson AJ. Exercise and Glaucoma: Positive Steps Toward Finding Another Modifiable Risk Factor to Prevent Vision Loss. Ophthalmology. 2019 Jul;126(7):965-966. doi: 10.1016/j.ophtha.2018.12.035. No abstract available.
- Tribble JR, Hui F, Joe M, Bell K, Chrysostomou V, Crowston JG, Williams PA. Targeting Diet and Exercise for Neuroprotection and Neurorecovery in Glaucoma. Cells. 2021 Feb 1;10(2):295. doi: 10.3390/cells10020295.
- Gildea D, Doyle A, O'Connor J. The Effect of Exercise on Intraocular Pressure and Glaucoma. J Glaucoma. 2024 Jun 1;33(6):381-386. doi: 10.1097/IJG.0000000000002411. Epub 2024 May 10.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HBCT-GLAU-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .