The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKU Leuven

About this trial

ACHIEVE aims to determine whether exercise can be a safe and effective non-drug approach to improve blood pressure control in patients with primary open-angle glaucoma (POAG). Although exercise is a promising and potentially well-accepted therapy, its use in clinical care is limited because the safety and effectiveness of different exercise types (aerobic, isometric, moderate, or high intensity) and timing (morning versus evening) have not been systematically studied in people with POAG and elevated blood pressure.

This study will evaluate the safety and short-term effects of different exercise modalities and timings on 24-hour ambulatory blood pressure and blood pressure variability in patients with POAG and elevated blood pressure.

It is hypothesized that:

* Each exercise session will lead to a temporary reduction in blood pressure (post-exercise hypotension). * The greatest and longest-lasting reduction will occur after high-intensity aerobic exercise performed in the morning.

It is also expected that all exercise types and timings will be safe for participants.

Eligibility criteria

Qualifiers

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

At least 18 years of age at the time of signing the Informed Consent Form (ICF)

Patients with POAG AND [elevated BP OR hypertension (Average SBP on office BP and Home BP ≥120 mmHg AND/OR Average DBP on office BP and Home BP ≥70 mmHg 26) with or without the use of anti-hypertensive medication]

Patients without recent changes in medication and glaucoma care within the past four weeks.

Disqualifiers

Not able to provide informed consent

SBP and/or DBP are ≥ 150 mmHg and/or ≥ 95 mmHg, respectively, on office BP at screening AND on home BP measurement conducted in the week following screening (to identify White Coat Hypertension) to ensure safety. These patients require referral for early treatment.

Aberrant cardiopulmonary exercise test (CPET) at screening (Life-threatening arrhythmias, ischemia,…)

Unable to perform one or more of the four exercise sessions due to physical and or mental limitations (severe lung disease, musculoskeletal issues, unstable angina,…)

Trial design

Treatments tested in this trial

  • Exercise

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

KU Leuven

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborator

Research Foundation Flanders

Collaborator