The Use of Neuromuscular Electrical Stimulation to Reverse Muscle Atrophy in Patients With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Volitional exercises; Other: Neuromuscular electrical stimulation

• Registration Number: NCT00924625
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study will be a small randomized clinical trial to test the effectiveness of neuromuscular electrical stimulation (NMES) to improve physical function and reverse muscle atrophy in patients with rheumatoid arthritis (RA). The investigators will also determine the mechanism by which NMES affects muscle hypertrophy and physical function. The proposed study will be the first step in demonstrating that NMES training is an effective alternative to highly intense volitional exercises (VE) in individuals with RA. After baseline testing, 60 individuals with RA will be randomly assigned to a 16-week NMES program or highly intense VE program. Both programs will be applied based on the best current clinical evidence. Subjects will be re-assessed after intervention. Groups will be compared for differences in performance-based and self-reported lower extremity function, muscle volume, muscle strength, proportion and area of type I and II muscle fibers, fat content, and muscle oxidative capacity from pre- to post-intervention. Changes in physical function, muscle volume, and muscle strength will be correlated with proportion and area of type I and II muscle fibers, fat content, and markers of muscle oxidative capacity.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-09
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• English-speaking
• Age 21 or older
• Diagnosed with RA for at least 5 years according to the criteria of the American College of Rheumatology
• Independent ambulator

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Exclusion Criteria

• History of cardiovascular disease or uncontrolled hypertension (above 140/90 mmHg);
• History of a quadriceps tendon or patellar tendon rupture;
• History of previous adverse reaction associated with electrical stimulation treatment;
• Surgery to the dominant lower extremities within the past 6 months.
• History of a neurological disorder that may affect lower extremity function, such as cerebrovascular accident or neuropathy, parkinson's disease, multiple sclerosis, etc.;
• History of muscle disease such as muscular dystrophy;
• Change in medication regimen (excluding NSAID change) during the month prior to treatment;
• Current use of cholesterol-lowering medication;
• History of malignancy during the last 5 years, excluding skin cancers other than melanoma;
• Current or anticipated pregnancy;
• Less than 70º of passive knee flexion;
• Are not willing to undergo needle biopsy.
• Participated in progressive resistance training or NMES training in the prior year;
• Prior adverse effects with local anesthesia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volitional exercises	Volitional exercises	VE will be used as in clinical practice based on an evidence-based approach. VE program will be the one shown to positively affect muscle hypertrophy and will follow the resistance training principles. Participants will receive 3 treatments/week for 12 weeks with at least 48h between training sessions
Neuromuscular electrical stimulation	Neuromuscular electrical stimulation	NMES will be used as in clinical practice based on an evidence-based approach. NMES will be applied at the participant's maximum tolerance. Participants will receive 3 treatments/week for 12 weeks with at least 48h between training sessions.

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery	4 months

Secondary Outcome Measures

Name	Time	Method
Muscle volume	4 months

Trial Locations

Locations (1)

Physical Therapy Department; 🇺🇸 Pittsburgh, Pennsylvania, United States