Carotid-Body modulation through Meditation in Hypertensive subjects

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2022
INTERVENTION: E02.190.525.374 This is a single‐center, blinded, parallel‐group‐based, prospective, randomized, controlled, blinded‐allocation clinical trial with an 8‐week follow‐up, analyzed with an intention‐to‐treat approach. Randomization will be performed by a researcher who will randomize subjects into two parallel groups through block randomization of 8 subjects, using random numbers generated by the random.org software. Another researcher will assign participants to the two groups, with an allocation ratio of 1:1. The opaque envelopes containing the study group allocation will be consecutively numbered and sealed. After the patient signs the Free and Informed Consent Form, the study investigator will open the envelope with the lowest remaining serial number and the patient will be appropriately allocated to a group. Subjects will be randomly assigned to two groups: the meditation group and the control group. Control group: the subjects will have an education‐type intervention focused on systemic arterial hypertension, which will be held in a class on Arterial Hypertension, and will be placed on a waiting list. Intervention group: they will perform transcendental meditation for 8 weeks, will be extensively informed about meditation, will receive about 1 hour of group information about meditation in the 1st session and, once a week, the subjects are guided about meditation by a professional therapist senior (Self‐Realization Fellowship member) in a 20‐minute session, in a suitable and comfortable room, seated comfortably and with eyes closed. In addition, a personal interview will be conducted to verify the meditation practice's correctness. During the week, subjects are trained to perform twice‐daily unsupervised 20‐minute meditation sessions at home CONDITION: Essential hypertension (primary) I51.6 PRIMARY OUTCOME: Evaluate changes in blood pressure under normoxia and under hyperoxia, analyze changes in carotid body activity at rest; all after 8 weeks of meditation, compared to the control group. Any blood pressure difference for normoxic or hyperoxic test greater than 5.9 mmHg, as determined by our reliability study, after 8 weeks will be considered a clinically significant result. To the best of our knowledge, there is no reproducibility study in hypertensive adults for resting carotid body activity SECONDARY OUTCOME: To analyze changes in resting ventilatory variability and resting ventilatory variability, both after 8 weeks of meditation, compared with the control group. Any difference in standard deviation 1 greater than 1.2 liters after 8 weeks of meditation will be considered a clinically significant result INCLUSION CRITERIA: Subjects of both sexes; aged between 30 and 70 years; patients with arterial hypertension or using at least one antihypertensive medication; stage I systemic arterial hypertension with a minimum diagnosis of 1 year; use of unchanged antihypertensive medication for at least 2 months; did not participate in regular exercise programs 3 or more times a week in the last 3 months prior to the study; are able to read; speak and understand Portuguese
Epistemonikos ID: 14918a286c3d6896623f31e9ac503e5ca80ee725
First added on: Aug 26, 2024