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

Официальное название

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.

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• 24 hours Ambulatory blood pressure [Срок оценки: During the 24-hour period beginning immediately after completion of each of the four experimental exercise sessions.]

Вторичные конечные точки (1)

• Intra-ocular pressure [Срок оценки: Immediately after completion of each of the four experimental exercise sessions.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• UZ Leuven/KU Leuven — Leuven

Идентификаторы

NCT: NCT07413614 · S69872_ACHIEVE · 1187925N

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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