High-Intensity Interval Training in Glaucoma
Summary description of the study
Glaucoma is a chronic inflammatory disease of the optic nerve, and it is estimated that 120 million people worldwide will be affected by the disease by 2040. The only available therapy is the reduction of intraocular pressure, either through surgical intervention or medication. However, more than one-third of patients with glaucoma in Europe do not have elevated intraocular pressure and experience disease progression. Often, damage to the small arteries and veins of the eye can be detected in these patients. Endurance training, particularly high-intensity interval training (HIT), can improve vascular health at the back of the eye. For this reason, the research project investigates the therapeutic effect of HIT on the development of glaucoma. This main study will be conducted at the research centers of the University of Basel and the University of Leuven (Belgium). It aims to investigate whether a 6-month HIIT leads to an improvement in vascular health at the back of the eye in patients with glaucoma, and whether this can measurably reduce disease progression over a one-year period. For this investigation, state-of-the-art devices will be used to measure the structure and function of the eye vessels in addition to standard ophthalmological diagnostics. We expect a significant improvement in vascular health at the back of the eye as well as an anti-inflammatory effect of the training therapy. It will also be investigated whether the expected effects lead to an improvement in vision in patients with glaucoma. If our expectations are confirmed, this would represent a new therapeutic option for the treatment of glaucoma.
(BASEC)
Intervention under investigation
6 months of physical training
(BASEC)
Disease under investigation
Glaucoma
(BASEC)
- voluntary written consent of the participant was obtained prior to screening - Patients with primary open-angle glaucoma (POWG), high-pressure glaucoma (HTG), and normal-pressure glaucoma (NTG), aged 40 to 80 years - Regular examination at one of the two study centers (BASEC)
Exclusion criteria
- Patients who underwent glaucoma surgery within 6 months prior to the start of the project - Patients with changes in topical medication or trabeculoplasty within 3 months prior to the start of the project - Patients with very severe glaucoma (mean visual field deviation less than -12Db) - Significant opacity of the eye - Patients with life-threatening arrhythmias, signs of ischemia during the exercise test, excluding participation in an exercise study - Patients with insulin-treated diabetes, chronic obstructive pulmonary disease, or cancer - Patients who perform ≥1 structured training session per week or who engage in more than 150 minutes per week of moderate to intense physical activity AND have a maximum oxygen uptake that exceeds 110% of the predicted oxygen uptake, assessed by the following two questions: a. On how many days per week do you typically engage in moderate to vigorous exercise (e.g., brisk walking)? b. How many minutes per day do you typically spend at this level of activity? Calculate total weekly movement minutes by multiplying a by b. - Mental or physical limitations that exclude participation in a high-intensity training program (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Department of Sport, Exercise and Health, University of Basel
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Henner Hanssen
+41 61 207 47 46
hit-glaucoma-dsbg@clutterunibas.chUniversity of Basel, Department of Sport, Exercise and Health, Grosse Allee 6, 4052 Basel, Switzerland
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
12.09.2023
(BASEC)
ICTRP Trial ID
NCT06058598 (ICTRP)
Official title (approved by ethics committee)
High intensity interval training in patients with glaucoma (HIT GLAUCOMA) (BASEC)
Academic title
High Intensity Interval Training in Patients With Glaucoma (ICTRP)
Public title
Exercise Training in Patients With Glaucoma (ICTRP)
Disease under investigation
Glaucoma, Open-AngleExercise TrainingMicrovascular Health (ICTRP)
Intervention under investigation
Other: Exercise TrainingOther: Lifestyle Counselling (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Voluntary written informed consent of the participant has been obtained prior to any
screening procedures
- Patients with primary open angle glaucoma (POAG), high tension glaucoma (HTG) and
normal tension glaucoma (NTG), aged 40 - 75 years
- In regular follow-up in either of the two study centres
Exclusion Criteria:
- Patients having had glaucoma surgery within 6 months before start of the project
- Patients with changes in topical medication or laser trabeculoplasty within 3 months
before start of the project
- Patients with very severe glaucoma (visual field mean deviation lower than -12Db)
- Significant opacification of ocular media
- Patients with life-threatening arrhythmia, signs of ischemia during CPET which
preclude participation in an exercise trial
- Patients with insulin treated diabetes, chronic obstructive pulmonary disease or
cancer.
- Patients doing =1 structured exercise training session per week or >150min of
exercise/week assessed via the following two questions: a. On average, how many days
per week do you engage in moderate to vigorous physical activity (like brisk
walking)? b. On average, how many minutes per day do you engage in physical activity
at this level? Calculate the total weekly minutes of exercise by multiplying a times
b.
- Mental or physical limitation precluding participation in a high intensity exercise
program (ICTRP)
not available
Primary and secondary end points
Microvascular health: retinal arteriolar and venular dilation and diameters (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Universitaire Ziekenhuizen KU Leuven;University Hospital, Basel, Switzerland (ICTRP)
Additional contacts
Henner Hanssen, Prof. Dr.;Henner Hanssen, Prof., henner.hanssen@unibas.ch, +41 61 207 47 46;+41 61 207 47 46 (ICTRP)
Secondary trial IDs
2023-01397 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06058598 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available