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

February 9, 2026 updated by: Véronique Cornelissen, KU Leuven

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven/KU Leuven
        • Contact:
        • Principal Investigator:
          • Véronique Cornelissen, MSc, PhD, Associate Professor
        • Sub-Investigator:
          • Marie Renier, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Evening Group
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

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
Other Names:
  • High intensity interval training
  • Moderate continuous training
  • Wall squatting
  • Isometric resistance training
Experimental: Morning Group
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
Other Names:
  • High intensity interval training
  • Moderate continuous training
  • Wall squatting
  • Isometric resistance training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24 hours Ambulatory blood pressure
Time Frame: During the 24-hour period beginning immediately after completion of each of the four experimental exercise 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.
During the 24-hour period beginning immediately after completion of each of the four experimental exercise sessions.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intra-ocular pressure
Time Frame: Immediately after completion of each of the four experimental exercise sessions.
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.
Immediately after completion of each of the four experimental exercise sessions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitaire Ziekenhuizen KU Leuven
Research Foundation Flanders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S69872_ACHIEVE
  • 1187925N (Other Grant/Funding Number: Research Foundation Flanders)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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