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

NCT01695421 | Unknown

• 1 other identifier: CSF-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Transcutaneous Electric Nerve Stimulation; Oxygen Consumption; Heart Failure

Outcome Measures

Primary Outcomes (1)

• VE/VCO2 slope

  Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.

Secondary Outcomes (6)

• Peak VO2

  Change from Baseline in Peak VO2 at five and ten weeks post EMS.

• VO2 at Ventilatory Threshold

  Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS.

• Perceived quality of life

  Change from Baseline in perceived quality od life at five and ten weeks post EMS.

• Muscle force

  Change from Baseline in muscle force at five and ten weeks post EMS.

• Muscle electrical activity

  Change from Baseline in muscle electrical activity at five and ten weeks post EMS.

Study Arms (4)

Functional electrical stimulation

EXPERIMENTAL

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

Procedure: Functional electrical stimulation

Medium-frequency alternating current

EXPERIMENTAL

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

Procedure: Medium-frequency alternating current

Burst-modulated alternating current

EXPERIMENTAL

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

Procedure: Burst-modulated alternating current

Placebo

PLACEBO COMPARATOR

Training with the intensity of 5 mA.

Procedure: Placebo

Interventions

Medium-frequency alternating current 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.

Also known as: MAC

Medium-frequency alternating current

Burst-modulated alternating current 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.

Also known as: BMAC

Burst-modulated alternating current

Placebo 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.

Placebo

Functional electrical stimulation 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

Functional electrical stimulation

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Brasilia University

Brasília, Federal District, 72220-140, Brazil

RECRUITING

Related Publications (4)

• 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.

  PMID: 22113369 BACKGROUND

• 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.

  PMID: 14760336 BACKGROUND

• 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.

  PMID: 14960741 BACKGROUND

• 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.

  PMID: 24418570 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gerson Cipriano Junior, PhD

  University of Brasilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerson Cipriano Junior, PhD

CONTACT

+556181907111; cipriano@unb.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 28, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2015
• Last Updated: June 10, 2013

Record last verified: 2012-09

Locations

BR (1)