Clinical trial NCT00924625: The Use of Neuromuscular Electrical Stimulation to Reverse Muscle Atrophy in Patients With Rheumatoid Arthritis
Official title: The Use of Neuromuscular Electrical Stimulation to Reverse Muscle Atrophy in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: 4 months
Secondary outcomes:
measure: Muscle volume
timeFrame: 4 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Physical Therapy Department
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sara R Piva, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almeida GJ, Khoja SS, Piva SR. Dose-Response Relationship Between Neuromuscular Electrical Stimulation and Muscle Function in People With Rheumatoid Arthritis. Phys Ther. 2019 Sep 1;99(9):1167-1176. doi: 10.1093/ptj/pzz079.
citation: Piva SR, Khoja SS, Toledo FGS, Chester-Wasko M, Fitzgerald GK, Goodpaster BH, Smith CN, Delitto A. Neuromuscular Electrical Stimulation Compared to Volitional Exercise for Improving Muscle Function in Rheumatoid Arthritis: A Randomized Pilot Study. Arthritis Care Res (Hoboken). 2019 Mar;71(3):352-361. doi: 10.1002/acr.23602. Epub 2019 Feb 12.
citation: Khoja SS, Moore CG, Goodpaster BH, Delitto A, Piva SR. Skeletal Muscle Fat and Its Association With Physical Function in Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Mar;70(3):333-342. doi: 10.1002/acr.23278. Epub 2018 Feb 6.