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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- KU Leuven
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 24 hours Ambulatory blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exercise (Behavioral)
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.
干预措施: Exercise (Behavioral)
结局指标
主要结局
24 hours Ambulatory blood pressure
时间窗: 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.
次要结局
- Intra-ocular pressure(Immediately after completion of each of the four experimental exercise sessions.)
研究者
Véronique Cornelissen
Associate Professor, Head of the Research Group for Rehabilitation in Internal Disorders
KU Leuven