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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924625
• Other study ID #: K01HD058035-01
• Status: Completed
• Phase: N/A
• First received: June 18, 2009
• Last updated: September 9, 2014
• Start date: June 2009
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Muscular Atrophy
• Rheumatoid Arthritis

Intervention

Other:
• Neuromuscular electrical stimulation
Strength of the quadriceps muscles will be tested at the beginning of each session. During administration of the NMES participant will sit with the knees bent at 70 degrees. The force sensing pad will be secured to the ankle joint. Two electrodes will be placed on the thigh muscle; one near the hip and the other near the knee joint. The intensity of NMES will be increased gradually according with tolerance. During each treatment 15 electrically elicited muscle contractions will be administered to each thigh. Each contraction will last 14 sec followed by 1min rest.
• Volitional exercises
The training will include bilateral exercises using resistance equipment (Leg Extension and Leg Press machines). Each resistance exercise will have: (a) dynamic muscle action at moderate repetition velocity (1-2 s concentric, 1-2 s eccentric, 2-3 s interval); (b) 3 sets of 8 repetitions with a load corresponding to 80% of one repetition maximum(1-RM); (c) 2-min rest period between sets and exercises.

Locations

Country	Name	City	State
United States	Physical Therapy Department	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery		4 months	No
Secondary	Muscle volume		4 months	No