The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Glaucoma Open-Angle Primary, Hypertension, Elevated Blood Pressure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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
Primary outcome measures
- 24 hours Ambulatory blood pressure [Time frame: During the 24-hour period beginning immediately after completion of each of the four experimental exercise sessions.]
Secondary outcome measures (1)
- Intra-ocular pressure [Time frame: Immediately after completion of each of the four experimental exercise sessions.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- UZ Leuven/KU Leuven — Leuven
Identifiers
NCT: NCT07413614 · S69872_ACHIEVE · 1187925N