The Effect of a Five Week Electrical Myostimulation Program in Chronic Diseases

NCT ID: NCT01695421

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-07-31

Brief Summary

Patients afflicted with Chronic Heart Failure (HF) typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Several investigations have demonstrated that electrical muscle stimulation (EMS) produces positive physiologic and psychological adaptations in patients with HF. However not all the EMS modalities were been evaluated on this population or not even were tested based on present recognized gold standard clinical parameters after a short period of treatment. The primary aims of the proposed study is to: Determine the effect of a five week home based of three EMS modalities on prognostics markers, perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF.

Detailed Description

Introduction: Chronic Heart Failure (HF) patients are a significant health care burden in many countries. Patients afflicted with HF typically do not maintain stable cardiac function for the remainder of their life and consequently require continuous medical management and intermittent hospital admissions. Several investigations have demonstrated that electrical muscle stimulation (EMS) produces positive physiologic and psychological adaptations in patients with HF. However not all the EMS modalities were been evaluated on this population or not even were tested based on present recognized gold standard clinical parameters after a short period of treatment. The impact of use of low frequency (FES) and medium-frequency currents (MAC and BMAC) as EMS on the VE/VCO2 and BNP has likewise not been investigated in patients with HF.

Purposes: The primary aims of the proposed study is to: Determine the effect of a five week home based EMS modalities (a) Functional electrical stimulation (FES), (b) medium-frequency alternating current (MAC) and (c) burst-modulated medium-frequency alternating current (BMAC) training program on the VE/VCO2 slope, Brain Natriuretic Peptide (BNP) level, peak VO2, VO2 at Ventilatory Threshold (VT), perceived quality of life, muscle force and electrical activity in subjects diagnosed with HF (NYHA III and IV). Examine changes in the previously outlined outcome measurements five weeks after cessation of the EMS ((a) FES, (b) MAC and (c) BMAC) training program.

Procedures: We will recruit 40 persons (10 for each EMS modalities and 10 control subjects) diagnosed with HF. A group of control subjects will participate using a sham current. The protocol can be conceptually divided into four sections in the following chronological sequence: (1) baseline assessment (body composition by a bone densitometer X-ray Dual energy X-Ray absortometry - DXA, Resting blood pressure and heart rate, complete blood count and BNP analysis); Living with Heart Failure Questionnaire (MLWHFQ); A physician-supervised maximal aerobic exercise test using a metabolic cart (Vmax, Viasys, USA) (VO2, VE/VCO2, VT); isokinetic peak torque (Biodex System III, Isokinetic Dynamometer, Biodex Medical, Inc., Shirley, NY) and electrical activity (Miotec, Brazil), (2) five week EMS training program (bilateral quadriceps and gastrocnemius for 5 days a week for 1 hour to each muscle group with FES, MAC and BMAC training program), (3) immediate post-training assessment within 5 days of completion of the EMS training program and a (4) final analysis five weeks after cessation of the EMS training program.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Functional electrical stimulation

Burst modulated alternating rectified current with a 10 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts

Group Type: EXPERIMENTAL

Functional electrical stimulation

Intervention Type: PROCEDURE

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction

Medium-frequency alternating current

Burst modulated alternating current with a 2500 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts

Group Type: EXPERIMENTAL

Medium-frequency alternating current

Intervention Type: PROCEDURE

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.

Burst-modulated alternating current

Burst modulated alternating current with a 4000 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts.

Group Type: EXPERIMENTAL

Burst-modulated alternating current

Intervention Type: PROCEDURE

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.

Placebo

Training with the intensity of 5 mA.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be fixed on 5 mA.

Interventions

Medium-frequency alternating current

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.

Intervention Type: PROCEDURE

Burst-modulated alternating current

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.

Intervention Type: PROCEDURE

Placebo

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be fixed on 5 mA.

Intervention Type: PROCEDURE

Functional electrical stimulation

The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction

Intervention Type: PROCEDURE

Other Intervention Names

MAC; BMAC

Eligibility Criteria

Inclusion Criteria

• (1) Male or female ≥ 21 and ≤ 80 years of age.
• (2) Current HF symptoms consistent with NYHA class III-IV.
• (3) On stable HF pharmacological therapy for at least one month prior to data collection.
• (4) Left ventricular ejection fraction < 45% documented within 3 months of enrollment (obtained from subjects medical records).
• (5) No planned elective surgery or pacemaker implantation at the time of study initiation.
• (6) Hgb > 8.0 within 1 month of enrollment (obtained from subjects medical records).
• (7) Willingness to provide written informed consent.

Exclusion Criteria

• (1) Inability to provide written informed consent.
• (2) Inability to walk on a treadmill.
• (3) Hemodynamically significant valvular heart disease.
• (4) Unstable angina.
• (5) Acute myocardial infarction within the previous 3 months.
• (6) Obstructive hypertrophic cardiomyopathy.
• (7) HF known to be secondary to pericardial disease or uncorrected valvular disease.
• (8) Chronic oxygen therapy.
• (9) Participation in another clinical trial within the past 30 days.
• (10) Participation in a regular exercise within the previous 6 months.
• (11) Previous implantation of a cardiac pacemaker or defibrillator.
• (12) Pregnancy.
• (13) Resting systolic blood pressure > 200 mmHg.
• (14) Failure to demonstrate the ability to operate the EMS unit.
• (15) Failure to be compliant with at least 75% of the EMS training sessions.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Brasilia

OTHER

Sponsor Role: lead

Responsible Party

Gerson Cipriano Jr

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerson Cipriano Junior, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

Brasilia University

Brasília, Federal District, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gerson Cipriano Junior, PhD

Role: CONTACT

cipriano@unb.br

+556181907111

Facility Contacts

Gerson Cipriano Junior, PhD

Role: primary

cipriano@unb.br

+556181907111

Laura Maria T Neves, Master

Role: backup

lmtomazi@gmail.com

+5581431769

References

Myers J, Gademan M, Brunner K, Kottman W, Boesch C, Dubach P. Effects of high-intensity training on indices of ventilatory efficiency in chronic heart failure. J Cardiopulm Rehabil Prev. 2012 Jan-Feb;32(1):9-16. doi: 10.1097/HCR.0b013e3182343bdf.

Reference Type: BACKGROUND

PMID: 22113369 (View on PubMed)

Arena R, Myers J, Aslam SS, Varughese EB, Peberdy MA. Peak VO2 and VE/VCO2 slope in patients with heart failure: a prognostic comparison. Am Heart J. 2004 Feb;147(2):354-60. doi: 10.1016/j.ahj.2003.07.014.

Reference Type: BACKGROUND

PMID: 14760336 (View on PubMed)

Mueller C, Scholer A, Laule-Kilian K, Martina B, Schindler C, Buser P, Pfisterer M, Perruchoud AP. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004 Feb 12;350(7):647-54. doi: 10.1056/NEJMoa031681.

Reference Type: BACKGROUND

PMID: 14960741 (View on PubMed)

Vieira PJ, Chiappa AM, Cipriano G Jr, Umpierre D, Arena R, Chiappa GR. Neuromuscular electrical stimulation improves clinical and physiological function in COPD patients. Respir Med. 2014 Apr;108(4):609-20. doi: 10.1016/j.rmed.2013.12.013. Epub 2014 Jan 2.

Reference Type: DERIVED

PMID: 24418570 (View on PubMed)

Other Identifiers

CSF-01

Identifier Type: -

Identifier Source: org_study_id