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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Brasilia
Sponsor:
Information provided by (Responsible Party):
Gerson Cipriano Jr, University of Brasilia
ClinicalTrials.gov Identifier:
NCT01695421
First received: September 19, 2012
Last updated: June 6, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention
Heart Failure
Procedure: Medium-frequency alternating current
Procedure: Burst-modulated alternating current
Procedure: Placebo
Procedure: Functional electrical stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Soft-hard Technologies to Assistance and Accessibility in Patients With Chronic Diseases: The Effect of a Five Week Electrical Myostimulation Program.

Resource links provided by NLM:


Further study details as provided by University of Brasilia:

Primary Outcome Measures:
  • VE/VCO2 slope [ Time Frame: Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peak VO2 [ Time Frame: Change from Baseline in Peak VO2 at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  • VO2 at Ventilatory Threshold [ Time Frame: Change from Baseline in VO2 at ventilatory threshold at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  • Perceived quality of life [ Time Frame: Change from Baseline in perceived quality od life at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  • Muscle force [ Time Frame: Change from Baseline in muscle force at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  • Muscle electrical activity [ Time Frame: Change from Baseline in muscle electrical activity at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]
  • Brain Natriuretic Peptide level [ Time Frame: Change from Baseline in Brain Natriuretic Peptide Level at five and ten weeks post EMS. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional electrical stimulation
Burst modulated alternating rectified current with a 10 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts
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
Experimental: Medium-frequency alternating current
Burst modulated alternating current with a 2500 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts
Procedure: 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.
Other Name: MAC
Experimental: Burst-modulated alternating current
Burst modulated alternating current with a 4000 Hz carrier frequency, 400 microsecond pulse duration and 50 Hz bursts.
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.
Other Name: BMAC
Placebo Comparator: Placebo
Training with the intensity of 5 mA.
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695421

Contacts
Contact: Gerson Cipriano Junior, PhD +556181907111 cipriano@unb.br

Locations
Brazil
Brasilia University Recruiting
Brasilia, Federal District, Brazil, 72220-140
Contact: Gerson Cipriano Junior, PhD    +556181907111    cipriano@unb.br   
Contact: Laura Maria T Neves, Master    +5581431769    lmtomazi@gmail.com   
Principal Investigator: Gerson Cipriano Junior, PhD         
Sub-Investigator: Laura Maria T Neves, Master         
Sponsors and Collaborators
University of Brasilia
Investigators
Principal Investigator: Gerson Cipriano Junior, PhD University of Brasilia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerson Cipriano Jr, Professor, University of Brasilia
ClinicalTrials.gov Identifier: NCT01695421     History of Changes
Other Study ID Numbers: CSF-01
Study First Received: September 19, 2012
Last Updated: June 6, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Brasilia:
Transcutaneous Electric Nerve Stimulation
Oxygen Consumption
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Chronic Disease
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014