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Carotid-Body modulation through Meditation in Hypertensive subjects

Carotid-Body modulation through Meditation in stage-I Hypertensive subjects: study protocol of a randomized and controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-55n74zm
Enrollment
Unknown
Registered
2022-07-28
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential hypertension (primary)

Interventions

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. R
E02.190.525.374

Sponsors

Universidade Federal de Mato Grosso do Sul
Lead Sponsor
Hospital Universitário Maria Aparecida Pedrossian
Collaborator

Eligibility

Age
30 Years to 70 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Subjects who do not adhere to the experimental protocol; who have a diagnosis of heart failure greater than or equal to New York Heart Association I; chronic obstructive pulmonary disease; cognitive impairment that makes it impossible to understand the protocols; or psychiatric disease; previous stroke; neuromuscular disease; asthma; uncontrolled diabetes; vascular disease peripheral; obesity grade III; renal failure of stage greater than 2; sleep apnea; malnutrition; or other diseases that interfere with the performance of the protocol; and lack of more than two sessions of supervised meditation; secondary hypertension; individuals with contraindications to performing a symptom-limited maximal exercise test; and individuals who regularly practice meditation

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactTiago;Paulo Augusto;Muller

Universidade Federal de Mato Grosso do Sul;Universidade Federal de Mato Grosso do Sul

tiagofisioterapeuta@hotmail.com;paulo.muller@ufms.br+55 (67) 992234830;+55 (67) 992910441

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 10, 2026