Heart Failure
Conditions
Keywords
heart failure, heart transplant, electrical stimulation
Brief summary
This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list. All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. The outcome will be assessed by the improvement in quality of life and functional capacity.
Detailed description
The neuromuscular electrical stimulation (NMES) has been used as adjuvant treatment in patients with end-stage congestive heart failure. Those patients are limited to perform conventional physical activity and adherence to any every day protocols frequency. The aim of this study was evaluated the effect on functional status and quality of life after NMES treatment using Russian stimulation wave solely twice a week during five weeks period in patients waiting for a heart transplant. Inclusion criteria: Age between 30 to 80 years old Congestive heart failure in NYHA class III or IV Ejection fraction lower than 35% Stable clinical status Full pharmacologic treatment Exclusion criteria: Unstable angina Ventricular arrhythmia intermittent lameness Inferior limb amputation Protocol Design: Patients at waiting list for heart transplant will be invited to participate on protocol of NMES using Russian stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec), named NMES group or sham stimulation, named control group. The NMES will be applied for 50 minutes, twice a week on both quadriceps femoral muscles during 7 weeks. The patients will be evaluated every week for distance walked during six minutes walk test (6MWT), heart rate variability, and functional status according to New York Heart Association. All patients were evaluated at the beginning and after completion of the protocol for quality of life with Minnesota Living with Heart Failure Questionnaire (LHFQ).
Interventions
DEVICEstimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
DEVICESham
very low electric muscular stimulation
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients on waiting list for heart transplant
Exclusion criteria
* patients that won't accept to participate in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement on distance walked in the six minute walk test | after 7 weeks of first inttervention |
Secondary
| Measure | Time frame |
|---|---|
| Improvement on quality of life | 7 weeks after first intervention |
Countries
Brazil
Contacts
Primary ContactMaria Carolina Sacilotto, MsC
Backup ContactOrlando Petrucci, MD, PhD
Outcome results
None listed