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Exercise Training in Patients With Glaucoma (HIT GLAUCOMA)

Primary Purpose

Glaucoma, Open-Angle, Exercise Training, Microvascular Health

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise Training
Lifestyle Counselling
Sponsored by
Henner Hanssen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Group performing exercise training and receiving standard care

    Group receiving lifestyle counseling and receiving standard care

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Henner Hanssen
    Collaborators
    Universitaire Ziekenhuizen KU Leuven, University Hospital, Basel, Switzerland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06058598
    Brief Title
    Exercise Training in Patients With Glaucoma
    Acronym
    HIT GLAUCOMA
    Official Title
    High Intensity Interval Training in Patients With Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Henner Hanssen
    Collaborators
    Universitaire Ziekenhuizen KU Leuven, University Hospital, Basel, Switzerland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Open-Angle, Exercise Training, Microvascular Health

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Group performing exercise training and receiving standard care
    Arm Title
    Control Group
    Arm Type
    Experimental
    Arm Description
    Group receiving lifestyle counseling and receiving standard care
    Intervention Type
    Other
    Intervention Name(s)
    Exercise Training
    Intervention Description
    6-months supervised exercise training + 6 months unsupervised exercise training
    Intervention Type
    Other
    Intervention Name(s)
    Lifestyle Counselling
    Intervention Description
    12-months of lifestyle counselling
    Primary Outcome Measure Information:
    Title
    Microvascular health: retinal arteriolar and venular dilation and diameters
    Description
    Retinal arteriolar and venular flicker light-induced dilation after six months; Retinal arteriolar and venular diameters after six months
    Time Frame
    6-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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. Mental or physical limitation precluding participation in a high intensity exercise program
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Henner Hanssen, Prof. Dr.
    Phone
    +41 61 207 47 46
    Email
    henner.hanssen@unibas.ch

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Exercise Training in Patients With Glaucoma

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