NCT06058598

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Dec 2023Sep 2026

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

December 17, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

September 21, 2023

Last Update Submit

December 9, 2025

Conditions

Glaucoma, Open-AngleExercise TrainingMicrovascular Health

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Group performing exercise training and receiving standard care

Other: Exercise Training

Control Group

EXPERIMENTAL

Group receiving lifestyle counseling and receiving standard care

Other: Lifestyle Counselling

Interventions

Exercise TrainingOTHER

6-months supervised exercise training + 6 months unsupervised exercise training

Intervention Group
Lifestyle CounsellingOTHER

12-months of lifestyle counselling

Control Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Department of Sport, Exercise & Health

Basel, 4052, Switzerland

Location

Related Publications (1)

  • Van Eijgen J, Schuhmann V, Fingerroos EL, Renier M, Burchert H, Kropfl JM, Van Craenenbroeck A, Cornelissen V, Gugleta K, Stalmans I, Hanssen H. High-intensity interval training in patients with glaucoma (HIT-GLAUCOMA): protocol for a multicenter randomized controlled exercise trial. Front Physiol. 2024 May 16;15:1349313. doi: 10.3389/fphys.2024.1349313. eCollection 2024.

    PMID: 38818519DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Exercise

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

December 1, 2023

Primary Completion

March 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)