Electrical Stimulation for Attenuating Muscle Atrophy

NCT02321163 | Unknown DMC

• 1 other identifier: HMRF12131991
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: This study aims to examine the use of low frequency (2Hz), low amplitude (intensity just produce visible muscle contraction), and long duration (2x3 hrs/day) neuromuscular electrical simulation (NMES) in attenuating the effects of muscle atrophy resulted from disuse. Design and subjects: The study is a randomized, double-blind, controlled, and parallel group study. Subjects with stable chronic obstructive pulmonary disease (COPD) will be included. Intervention: Subjects will be randomized to 3 groups to receive different NMES program over the quadriceps and calf muscles: (i) the proposed NMES program; (ii) conventional NMES program (50Hz, 30 min/day), or sham group for a period of 8 weeks. Outcome measures:The effectiveness of the NMES will be evaluated by the improvement in muscle cross-sectional area (CSA), muscle performance (muscle strength, muscle shortening velocity and muscle activation testing), functional performance (6 min walk) and subjects' rating of the perceived acceptability of the stimulation protocol. Data analysis: Baseline characteristics of the intervention and sham groups will be compared using one way ANOVA. Two-way mixed repeated measures analysis of variance will be performed to examine the differences between groups over time for all the outcome variables. The significance level is set at p \< 0.05. Expected results: The investigators hypothesize that the proposed new paradigm of NMES would be more effective in improving muscle cross-sectional area (CSA), strength, endurance, and exercise tolerance.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Muscle cross sectional area (quadriceps and calf muscles)

  Ultrasonography of the quadriceps and calf muscle cross sectional area measured at baseline, week 4 and week 8 of the study.

  8 weeks

Secondary Outcomes (4)

• Isometric knee extensor and plantarflexor muscle torque

  8 weeks

• Muscle activation (Twitch interpolation technique will be used to assess the voluntary muscle activation)

  8 weeks

• Functional ability (improvement of the muscle strength will furthered be tested on the 6-min walk test)

  8 weeks

• Acceptability of the stimulation protocol (10 point scale)

  8 weeks

Study Arms (3)

NMES new paradigm

EXPERIMENTAL

For the NMES new paradigm, A portable electrical stimulator will be used to produce simultaneous stimulation to both the quadriceps and calf muscles. The stimulator delivers a biphasic, asymmetrical square wave at a pulse width of 250 μs and duty cycle 5:10 sec with 2 Hz frequencies of stimulation. To disperse current intensity and enhance the comfort of the stimulation, large rectangular electrodes (80 × 100 mm) will be positioned at the best motor points of the quadriceps and calf muscles. The electrodes will be secured by tight short and sock at the respective positions. The stimulation intensity will be set to just visible muscle contractions. Stimuli will be applied twice a day for 3 h (with a 2 h rest between treatments), 5 days a week for 8 weeks.

Device: NMES new paradigm

NMES conventional

ACTIVE COMPARATOR

For NMES conventional, the experimental protocol will be the conventional electrical stimulation protocol i.e frequency: 50 Hz; intensity: maximum intensity tolerated by the subject; duration: 30 min.

Device: NMES conventional

Placebo

SHAM COMPARATOR

For placebo, electrodes will be applied and all conditions will be similar to those in the NMES group, except that the amplitude will be set to 0 mA so that no muscle stimulation occurs.

Device: NMES no stimulation

Interventions

NMES new paradigm DEVICE

stimulation frequency: 2 Hz; intensity: low amplitude; duration: 3 hours, 2 times per day for 8 weeks

NMES new paradigm

NMES conventional DEVICE

stimulation frequency: 50 Hz; intensity: maximally tolerated; duration: 30 min per day for 8 weeks

NMES conventional

NMES no stimulation DEVICE

Placebo, electrode pad on, no stimulation

Placebo

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable COPD patients who had been discharged from the medical unit, and had been admitted less than 2 times in the preceding year;
• patients drawn from either pulmonary rehabilitation program in Day Care Centre; or self help group; or home bound;
• COPD subjects with Forced Expiratory Volume at 1 sec (FEV1) to Forced Vital Capacity (FVC) ratio: ≤ 70%, oxygen uptake maximum (VO2 max) ≤ 8 MET and BMI ≤ 21kg/m2

You may not qualify if:

• subjects with known muscle wasting diseases such as motor neuron disease, cachexia, e.g. cancer cachexia;
• subjects with muscle dysfunction as a result of neurological conditions such as stroke, Parkinsonism
• subjects that can not comply with the study procedures (e.g. dementia)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Hung Hom, HKG, Hong Kong

RECRUITING

Related Publications (17)

• Paddon-Jones D, Sheffield-Moore M, Cree MG, Hewlings SJ, Aarsland A, Wolfe RR, Ferrando AA. Atrophy and impaired muscle protein synthesis during prolonged inactivity and stress. J Clin Endocrinol Metab. 2006 Dec;91(12):4836-41. doi: 10.1210/jc.2006-0651. Epub 2006 Sep 19.

  PMID: 16984982 BACKGROUND

• Greenhaff PL. The molecular physiology of human limb immobilization and rehabilitation. Exerc Sport Sci Rev. 2006 Oct;34(4):159-63. doi: 10.1249/01.jes.0000240017.99877.8a.

  PMID: 17031253 BACKGROUND

• Fitts RH, Riley DR, Widrick JJ. Functional and structural adaptations of skeletal muscle to microgravity. J Exp Biol. 2001 Sep;204(Pt 18):3201-8. doi: 10.1242/jeb.204.18.3201.

  PMID: 11581335 BACKGROUND

• Fitts RH, Riley DR, Widrick JJ. Physiology of a microgravity environment invited review: microgravity and skeletal muscle. J Appl Physiol (1985). 2000 Aug;89(2):823-39. doi: 10.1152/jappl.2000.89.2.823.

  PMID: 10926670 BACKGROUND

• Adams GR, Caiozzo VJ, Baldwin KM. Skeletal muscle unweighting: spaceflight and ground-based models. J Appl Physiol (1985). 2003 Dec;95(6):2185-201. doi: 10.1152/japplphysiol.00346.2003.

  PMID: 14600160 BACKGROUND

• Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.

  PMID: 17299744 BACKGROUND

• Bax L, Staes F, Verhagen A. Does neuromuscular electrical stimulation strengthen the quadriceps femoris? A systematic review of randomised controlled trials. Sports Med. 2005;35(3):191-212. doi: 10.2165/00007256-200535030-00002.

  PMID: 15730336 BACKGROUND

• Maddocks M, Gao W, Higginson IJ, Wilcock A. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD009419. doi: 10.1002/14651858.CD009419.pub2.

  PMID: 23440837 BACKGROUND

• Maffiuletti NA, Roig M, Karatzanos E, Nanas S. Neuromuscular electrical stimulation for preventing skeletal-muscle weakness and wasting in critically ill patients: a systematic review. BMC Med. 2013 May 23;11:137. doi: 10.1186/1741-7015-11-137.

  PMID: 23701811 BACKGROUND

• Petterson S, Snyder-Mackler L. The use of neuromuscular electrical stimulation to improve activation deficits in a patient with chronic quadriceps strength impairments following total knee arthroplasty. J Orthop Sports Phys Ther. 2006 Sep;36(9):678-85. doi: 10.2519/jospt.2006.2305.

  PMID: 17017273 BACKGROUND

• Sillen MJ, Franssen FM, Gosker HR, Wouters EF, Spruit MA. Metabolic and structural changes in lower-limb skeletal muscle following neuromuscular electrical stimulation: a systematic review. PLoS One. 2013 Sep 3;8(9):e69391. doi: 10.1371/journal.pone.0069391. eCollection 2013.

  PMID: 24019860 BACKGROUND

• Theriault R, Theriault G, Simoneau JA. Human skeletal muscle adaptation in response to chronic low-frequency electrical stimulation. J Appl Physiol (1985). 1994 Oct;77(4):1885-9. doi: 10.1152/jappl.1994.77.4.1885.

  PMID: 7836213 BACKGROUND

• Napolis LM, Dal Corso S, Neder JA, Malaguti C, Gimenes AC, Nery LE. Neuromuscular electrical stimulation improves exercise tolerance in chronic obstructive pulmonary disease patients with better preserved fat-free mass. Clinics (Sao Paulo). 2011;66(3):401-6. doi: 10.1590/s1807-59322011000300006.

  PMID: 21552662 BACKGROUND

• Banerjee P, Caulfield B, Crowe L, Clark AL. Prolonged electrical muscle stimulation exercise improves strength, peak VO2, and exercise capacity in patients with stable chronic heart failure. J Card Fail. 2009 May;15(4):319-26. doi: 10.1016/j.cardfail.2008.11.005. Epub 2009 Jan 29.

  PMID: 19398080 BACKGROUND

• Banerjee P, Caulfield B, Crowe L, Clark A. Prolonged electrical muscle stimulation exercise improves strength and aerobic capacity in healthy sedentary adults. J Appl Physiol (1985). 2005 Dec;99(6):2307-11. doi: 10.1152/japplphysiol.00891.2004. Epub 2005 Aug 4.

  PMID: 16081619 BACKGROUND

• Zhang BT, Yeung SS, Liu Y, Wang HH, Wan YM, Ling SK, Zhang HY, Li YH, Yeung EW. The effects of low frequency electrical stimulation on satellite cell activity in rat skeletal muscle during hindlimb suspension. BMC Cell Biol. 2010 Nov 18;11:87. doi: 10.1186/1471-2121-11-87.

  PMID: 21087483 RESULT

• Guo BS, Cheung KK, Yeung SS, Zhang BT, Yeung EW. Electrical stimulation influences satellite cell proliferation and apoptosis in unloading-induced muscle atrophy in mice. PLoS One. 2012;7(1):e30348. doi: 10.1371/journal.pone.0030348. Epub 2012 Jan 12.

  PMID: 22253929 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon S Yeung, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon S Yeung, PhD

CONTACT

85227666705; simon.yeung@polyu.edu.hk

Ella W Yeung, PhD

CONTACT

95227666748; ella.yeung@polyu.edu.hk

Study Design

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

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 22, 2014
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

HK (1)