Elevated Blood Pressure, Glaucoma Open-Angle Primary, Hypertension
Conditions
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
Brief 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 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
BEHAVIORALExercise
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
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Research Foundation Flanders
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hours Ambulatory blood pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-ocular pressure | 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. |
Countries
Belgium
Contacts
CONTACTVéronique Cornelissen, MSc, PhD, Associate Professor
CONTACTMarie Renier, MSc
Outcome results
None listed