Exercise Training in Patients With Glaucoma (HIT GLAUCOMA)

High Intensity Interval Training in Patients With Glaucoma

HIT GLAUCOMA is a multicenter exercise study for glaucoma patients between three institutes: the Department of Sport, Exercise and Health (DSBG) of the University of Basel, the Eye Clinic at the University Hospital Basel and the UZ Leuven (Belgium). The main objective of the study is to investigate the possibility of using exercise therapy to treat glaucoma. Participants will be randomly divided into two groups: Intervention and Control group. The intervention group will receive a high-intensity interval training plan, and the control group will receive lifestyle counseling and standard therapy. With this method, the study aims to validate an exercise therapy concept that could significantly improve disease progression and quality of life in patients with glaucoma.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle; Exercise Training; Microvascular Health
• Intervention / Treatment: Other: Exercise Training; Other: Lifestyle Counselling

Detailed Description

Approximately 57.5 million people are affected by primary open-angle glaucoma, and it is estimated that this number will increase to 111.8 million by 2040. Despite the high prevalence and critical outlook of the disease, the pathogenesis of glaucoma is still not fully understood and treatment options remain inadequate. In particular, for glaucoma with normal intraocular pressure, there is as yet no evidence-based effective treatment option. This particular type of glaucoma may, in part, be the result of impaired microvascular endothelial function. Physical training has a proven effect on vascular health; because glaucoma involves a vascular component, positive effects of high-intensity interval training can be assumed. Thus, it could be an effective treatment for glaucoma disease.

Patients will be randomly assigned to either the intervention or control group. Patients assigned to the intervention group will participate in a 6-month exercise training program followed by a 6-months non-supervised and home-based physical activity maintenance program. During the first 6 months, patients in the intervention group participate in 18 supervised exercise sessions at the DSBG, interspersed by unsupervised exercise interventions at home.

All patients will be seen at baseline, after three months and six months of aerobic exercise training, and after another six months of physical activity and exercise self-maintenance (intervention group) or control condition. Each subject will be asked to undergo standard ophthalmic examination, non-invasive retinal assessments, peripheral blood withdrawal, and additional peripheral vascular examinations. The study design is based on regular glaucoma follow-up intervals (every 6 months) and does not intervene with clinical care and governmental reimbursement of standard care. Patients will finish their study participation after 6 months of exercise training followed by 6 months of physical activity and exercise self-maintenance or control condition.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henner Hanssen, Prof. Dr.; Phone Number: +41 61 207 47 46; Email: henner.hanssen@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4052
    • Recruiting
    • University of Basel, Department of Sport, Exercise & Health
    • Contact: Henner Hanssen, Prof.; Phone Number: +41 61 207 47 46; Email: henner.hanssen@unibas.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• Mental or physical limitation precluding participation in a high intensity exercise program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Group performing exercise training and receiving standard care	Other: Exercise Training; 6-months supervised exercise training + 6 months unsupervised exercise training
Experimental: Control Group; Group receiving lifestyle counseling and receiving standard care	Other: Lifestyle Counselling; 12-months of lifestyle counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular health: retinal arteriolar and venular dilation and diameters	Retinal arteriolar and venular flicker light-induced dilation after six months; Retinal arteriolar and venular diameters after six months	6-months

Collaborators and Investigators

• Sponsor: Henner Hanssen
• Collaborators: Universitaire Ziekenhuizen KU Leuven; University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2023-01397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No