Glaucoma Open-Angle PrimaryACHIEVENCT07413614
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
A study testing Exercise in people with Glaucoma Open-Angle Primary and Hypertension, run by KU Leuven at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma Open-Angle Primary, Hypertension, Elevated Blood Pressure
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Home BP ≥120 mmHg AND/OR Average DBP on Home BP ≥70 mmHg) with or without the use of anti-hypertensive medication]
- Patients without recent changes in medication and glaucoma care within the past four weeks.
Who cannot join
- 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,…)
- Severe osteoarthritis pending knee replacement surgery (these patients may be unable to perform the IRE (i.e. wall squat exercise)
- Unable to communicate in Dutch
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- Active malignancy
- Participation in an interventional Trial with an investigational medicinal product (IMP), exercise intervention or device
- Unwillingness to repeat ABPM
- Relative contraindications to ABPM: diagnosed atrial fibrillation, nighttime workers, occupational drivers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Véronique Cornelissen, MSc, PhD, Associate Professor contact
Marie Renier, MSc contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven/KU Leuven
Leuven, 3000
Marie Renier, MSc, +32 16 34 25 48, marie.renier@kuleuven.be
Véronique Cornelissen, MSc, PhD, Associate Professor
About this study
Official title: The ACHIEVE-project: Advancing Cardiovascular and Ocular Health In Eye Patients. The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma.
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.
Read more
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.
- Being tested
- Exercise
- Keywords
- Ambulatory blood pressure, High intensity interval training, Isometric Exercise, Intra-ocular pressure, Moderate continuous training, Primary open angle glaucoma, Hypertension, Blood pressure variability, Exercise
- Medical subject headings
- Glaucoma, Open-Angle, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Moderate continuous training, High intensity interval training, Wall squatting, Isometric resistance training
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
| Study group | Role | What they receive |
|---|---|---|
| Evening Group | Experimental | 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. Receives: Behavioral: Exercise |
| Morning Group | Experimental | 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the 24-hour period beginning immediately after completion of each of the four experimental sessions.
Secondary outcomes (2)
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.
Measured: 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.
Measured: During the 24-hour period beginning immediately after completion of each of the four experimental sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start31 Jul 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Open-Angle PrimaryStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study is a single-center, prospective, randomized, controlled, crossover trial. A total of 60 participants will take part in two randomized crossover experiments. Each participant will complete four single exercise sessions, including one control session, in random order over a period of four to eight weeks. There will be at least one week between each session. Outcomes will be assessed after each experimental exercise session to evaluate the acute effects of different exercise modalities and timings. Participants will be assigned to one of two groups based on their preferred time of day. Thirty participants will perform all sessions in the morning (8:00-11:00 AM), and thirty will perform all sessions in the evening (5:00-8:00 PM). Each participant will complete all sessions at the same time of day and will be asked to maintain a consistent bedtime throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Research Foundation Flanders
- Responsible party
- Principal investigator, Véronique Cornelissen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413614
- Sponsor's protocol ID
- S69872_ACHIEVE
- Other IDs
- 1187925N
- Acronym
- ACHIEVE
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ACHIEVE-project: Advancing Cardiovascular and Ocular Health In Eye Patients. The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma.
- ClinicalTrials.gov ID
- NCT07413614
- Acronym / sponsor ID
- ACHIEVE / S69872_ACHIEVE
- Keywords
- Ambulatory blood pressure, High intensity interval training, Isometric Exercise, Intra-ocular pressure, Moderate continuous training, Primary open angle glaucoma, Hypertension, Blood pressure variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Research Foundation Flanders
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a single-center, prospective, randomized, controlled, crossover trial. A total of 60 participants will take part in two randomized crossover experiments. Each participant will complete four single exercise sessions, including one control session, in random order over a period of four to eight weeks. There will be at least one week between each session. Outcomes will be assessed after each experimental exercise session to evaluate the acute effects of different exercise modalities and timings. Participants will be assigned to one of two groups based on their preferred time of day. Thirty participants will perform all sessions in the morning (8:00-11:00 AM), and thirty will perform all sessions in the evening (5:00-8:00 PM). Each participant will complete all sessions at the same time of day and will be asked to maintain a consistent bedtime throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Evening Group | Experimental | Behavioral: ExerciseThirty 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. |
| Morning Group | Experimental | Behavioral: ExerciseThirty 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 Home BP ≥120 mmHg AND/OR Average DBP on Home BP ≥70 mmHg) with or without the use of anti-hypertensive medication]
- Patients without recent changes in medication and glaucoma care within the past four weeks.
Key exclusion criteria (10 listed)
- 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,…)
- Severe osteoarthritis pending knee replacement surgery (these patients may be unable to perform the IRE (i.e. wall squat exercise)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Moderate continuous training, High intensity interval training, Wall squatting, Isometric resistance trainingParticipants 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 | Behavioural | Evening Group, Morning Group |
Primary outcome
24 hours Ambulatory blood pressure
Time frame: During the 24-hour period beginning immediately after completion of each of the four experimental sessions.
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.
2 secondary outcomes
Intra-ocular pressure (safety outcome)
Time frame: Immediately after completion of each of the four experimental sessions.
Excessive nocturnal SBP reduction (safety outcome)
Time frame: During the 24-hour period beginning immediately after completion of each of the four experimental sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Véronique Cornelissen, MSc, PhD, Associate Professor contact
Marie Renier, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Glaucoma Open-Angle Primary and Hypertension, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique Cornelissen, MSc, PhD, Associate Professor (+32 16 32 91 52, veronique.cornelissen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hours Ambulatory blood pressure (time frame: During the 24-hour period beginning immediately after completion of each of the four experimental sessions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.