An interventional study of Exercise in Glaucoma Open-Angle Primary, Hypertension and Elevated Blood Pressure, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by KU Leuven · Not applicable, Interventional, and Treatment
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:
It is also expected that all exercise types and timings will be safe for participants.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 29, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thirty participants will complete four single experimental exercise sessions (of which one control session) in the evening (5-8 PM) in random order within a minimum of four weeks and a maximum of eight weeks separated by at least one week between two sessions.
Behavioral: Exercise
Thirty participants will complete four single experimental exercise sessions (of which one control session) in the morning (8-11 AM) in random order within a minimum of four weeks and a maximum of eight weeks separated by at least one week between two sessions.
Behavioral: Exercise
Participants will complete four single experimental exercise sessions in a randomized order within a maximum of eight weeks, separated by at least 1 week (7 days) between two sessions. Group allocation will be based on personal preference with 30 patients performing all exercise sessions in the morning (8-11 AM) and 30 patients performing all exercise sessions in the evening (5-8 PM). Each individual will perform his/her session on the same time of day and will be asked to go to bed at a similar time. The four bouts of exercise are defined according to the following FITT-parameters: * MCT: 1 session of indoor cycling at 65% of VO2-reserve, 45 min, aerobic endurance * HIIT: 1 session of indoor cycling, 4 min at 85% of VO2-reserve interspersed by 3 min at 60% of the VO2-reserve, 28 min, aerobic exercise * IRT: 1 session of wall squatting, 6 x 1 min (with 2 min seated rest between each set), specific knee joint angle corresponding to 95% of HR-reserve * CONTROL: Seated rest for 30
Also known as: Moderate continuous training, High intensity interval training, Wall squatting, Isometric resistance training
24 hours Ambulatory blood pressure
Participants will be provided with a validated automated monitor after each of the four experimental exercise session. The ABPMpro-Research model (SOMNOmedics GmbH, Randersacker, GER) will be used as this device allows for the simultaneous assessment of BP and physical activity. The device will be programmed to obtain ambulatory blood pressure readings at intervals of 15 minutes during the day (from 06 AM to 11 PM) and at 30 minutes intervals during the night (11 PM to 06 AM). The actual sleep time will be obtained by a sleep diary, which is the preferred method as shown by international recommendations. From the ABPM following outcome parameters will be derived (included but not limited to): evolution of ambulatory SBP (magnitude + duration of BP reduction) as primary outcome; secondary outcomes: mean daytime BP, mean nighttime, BP, BP variability and nighttime dipping profile.
Time frame: During the 24-hour period beginning immediately after completion of each of the four experimental sessions.
Intra-ocular pressure (safety outcome)
Intra-ocular pressure will be assessed immediately after the exercise session by using the iCare tonometry. The participant is seated comfortably in an upright position. The participant is asked to look straight ahead with the eyes opened avoiding squeezing the eyelids. The tonometer is held perpendicular to the corneal surface, at approximately 4-8mm distance from the center of the cornea. The device projects a sterile, single-use probe against the cornea using a gentle rebound motion. Upon contact, the probe decelerates and the rebound characteristics (speed and duration of deceleration) are used to calculate the IOP. Six consecutive measurements are taken per eye with the device automatically providing the mean IOP value, discarding outliers. An excessive IOP response is defined as an increase of ≥5 mmHg relative to the resting IOP measured immediately before the session.
Time frame: Immediately after completion of each of the four experimental sessions.
Excessive nocturnal SBP reduction (safety outcome)
Derived from the 24-hour ambulatory blood pressure recordings obtained after each session (see primary outcome). Excessive nocturnal SBP reduction is defined as a nocturnal SBP decline \>20% relative to daytime values (extreme dipping pattern). In addition, the peak nocturnal SBP dip, defined as the maximum observed nocturnal reduction in SBP relative to the daytime mean, will be assessed. The proportion of participants meeting these predefined safety thresholds will be compared between exercise conditions.
Time frame: During the 24-hour period beginning immediately after completion of each of the four experimental sessions.
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications, together with a data dictionary, will be made available from the corresponding author on reasonable request.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 12 months after publication of the main results, for a period of 5 years.
Access criteria: Requests should be directed to the corresponding author and include a description of the intended use. Data will be shared after approval by the study investigators and, where required, the ethics committee, and after signing a data transfer agreement in accordance with the GDPR.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.
Of 100 non-industry interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 8 months is below that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.
Start moved once since we started tracking on Sep 25, 2026: Apr 2026 → Jul 2026, on Oct 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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