Verification of the lactate threshold obtained from sweat measuring device for patients with heart failure

JRCT ID: jRCT2032220057

Registered date:11/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 18/05/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Mesurement of the sweat lactate with the clinical trial device attached to the forehead in a incrematnal exercise test

Outcome(s)

• Primary Outcome: Correlation coefficient between exercise loads in anaerobic thresthold and sweat lactate thresthold

Secondary Outcome

(1) Correlation coefficient between exercise prescription using anaerobic thresthold and sweat lactate thresthold
(2) Correlation coefficient between exercise loads in clinical anaerobic thresthold and sweat lactate thresthold
(3) Reliability between evaluators of clinical anaerobic thresthold and sweat lactate thresthold

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(1) Patients who can voluntarily obtain consent to participate in the clinical trial in writing from the patient.
(2) Men and women aged between 20 and 90 at the time of consent and suffering from New York Heart Association functional classification (NYHA) I or II heart failure.
(3) Patients planning to receive exercise therapy.

Exclude criteria

(1) Patients with severe skin diseases.
(2) Patients with lacerations at the device application site.
(3) Patients with extremely low sweating (confirmed by interview).
(4) Patients who are judged by the investigator, etc. to be inappropriate for this clinical trial.

Related Information

• Primary Sponsor: Katsumata Yoshinori
• Source(s) of Monetary Support: Grace imaging Inc.,Advanced Medical Devices Acceleration Project (AMDAP)