Skip to content

Biofeedback in improving diabetic heart health.

Cardiovascular biofeedback in autonomic neuropathy in individuals with Diabetes Mellitus type 2.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7xds2v
Enrollment
Unknown
Registered
2018-02-01
Start date
2018-01-03
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

Diabetes mellitus type 2.

Interventions

Participants will be randomized into two groups. One group will receive cardiovascular biofeedback training that will take place in three weekly sessions lasting 50 minutes for eight to twelve weeks u
Device
Behavioural

Sponsors

Universidade Federal de Pernambuco
Lead Sponsor
Universidade Federal de Pernambuco
Collaborator

Eligibility

Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: The following may be included in the study: individuals with Type 2 Diabetes mellitus of both sexes; aged 50-75 years; sedentary; no history of neurological diseases; muscular or rheumatic diseases outside the etiology of diabetes and that reside in the region of Greater Recife.

Exclusion criteria

Exclusion criteria: The exclusion criteria applied will be: presence of unstable angina; pacemaker; severe pneumopathies or other limiting diseases such as neoplasms; valvulopathies; advanced dementia; aortic aneurysm; renal insufficiency and decompensated heart failure. Individuals with orthopedic and / or neurological diseases that may not be able to perform the cardiopulmonary exercise test will also be excluded; besides the patients who present intellectual deficiencies that restrict them to answer the questionnaires and understand the proposed games.

Design outcomes

Primary

MeasureTime frame
Increase of 5% in heart rate variability as measured by the 24-hour Holter test. Data collected up to 2 weeks before and 2 weeks after the cardiovascular biofeedback training program.

Secondary

MeasureTime frame
Improvement of 10% in the rate of ventilation oscillation during exercise, as measured by the ergospirometry test. Data collected up to 3 weeks before and 3 weeks after the cardiovascular biofeedback training program.

Countries

Brazil

Contacts

Public ContactSílvia ;Tainá Moraes;Vidal

Universidade Federal de Pernambuco;Universidade Federal de Pernambuco

sramoraes@gmail.com;taimaria@gmail.com+55-081-21268567;+55-081-91039194

Outcome results

None listed

Source: REBEC (via WHO ICTRP)