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| ID | Type | Description | Link |
|---|---|---|---|
| 1187925N | Other Grant/Funding Number | Research Foundation Flanders |
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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Research Foundation Flanders | OTHER |
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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:
It is also expected that all exercise types and timings will be safe for participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evening Group | Experimental | 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. |
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| Morning Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 24 hours Ambulatory blood pressure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-ocular pressure | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Véronique Cornelissen, MSc, PhD, Associate Professor | Contact | +32 16 32 91 52 | veronique.cornelissen@kuleuven.be | |
| Marie Renier, MSc | Contact | marie.renier@kuleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven/KU Leuven | Leuven | 3000 | Belgium |
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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.
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| Immediately after completion of each of the four experimental exercise sessions. |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D064797 | Physical Conditioning, Human |
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