| Project Detail |
Background and rationalGlaucoma is the global leading cause of irreversible blindness and at least one third of glaucoma patients show disease progression despite sufficient lowering of intraocular pressure (IOP). An effective treatment for IOP-controlled but progressing normal tension (NTG) and high tension primary open angle glaucoma (HTG) is lacking. Treatment resistance, to a large extent, is esteemed to be the result of impaired microvascular endothelial function, chronic inflammation and oxidative stress. These risk factors are known to affect retinal neuronal networks and microvascular function and have been associated with disease severity and progression of glaucoma. Exercise is known for its anti-inflammatory and anti-oxidative properties as well as for improving endothelial function as key modulator of local blood flow. High-intensity interval training (HIIT) has been shown to improve retinal endothelial function as assessed by flicker light-induced dilation (FID) of retinal arterioles and venules in older adults with cardiovascular disease. Aims and hypothesisThis study tackles the described research gap by applying an innovative add-on exercise treatment approach on top of usual care. Exercise therapy has never been studied in glaucoma patients. The HIT GLAUCOMA study aims to treat microvascular dysfunction and associated inflammation as well as oxidative stress in patients with glaucoma by prescription of HIIT. We hypothesize that state-of-the art exercise therapy will improve retinal microvascular function and, thereby, ocular blood and oxygen supply in glaucoma patients.Study design and methodsThe study is a multi-centre randomized controlled exercise trial in patients with glaucoma. In each study centre, 64 patients with NTG and HTG will be enrolled from the eye clinics and undergo screening of clinical ophthalmological features, static and dynamic retinal vessel analysis as well as cardiopulmonary exercise tests. Patients will be randomized into an exercise training group (HIIT) and a control group (CG) with lifestyle recommendations. After six months of exercise training or control condition, patients are reassessed and data from both study centres are merged and analysed. The primary end points are arteriolar and venular FID after six months of exercise training versus control condition. To analyse intervention effects after 6 months, we will use analysis of covariance (ANCOVA) according to the intention-to-treat principle to compare differences in primary and secondary endpoints between HIIT and control group, corrected for the corresponding baseline value and main confounders.Expected results and impactThe primary expected result is to prove exercise efficacy after six months for improvement of retinal microvascular function in glaucoma patients. As secondary outcomes, we expect to show improvement or reduced progression of visual field indices and use of eye drops or need for surgery after 12 months. The state-of-the-art HIIT sees to the limit of what can be achieved by exercise treatment in an elderly population, decreasing the chance on falsely negative results. If proven efficient, this study immediately can exert its high impact via clinical recommendations in glaucoma care. The new exercise treatment strategy can be filed directly for govern-mental or health insurance reimbursement since the study protocol is designed in analogy with existing protocols for prevention and rehabilitation programs. Furthermore, mobilization of older adults is beneficiary for their general health, and concomitant treatment of cardiovascular co-morbidities is an effective means to improve their expected health span and quality of life. |
