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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Volitional exercises
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical Therapy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular electrical stimulation

Volitional exercises

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Short Physical Performance Battery

Secondary Outcome Measures

Muscle volume

Full Information

First Posted
June 18, 2009
Last Updated
September 9, 2014
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00924625
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Volitional exercises
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation
Other Intervention Name(s)
Electrical Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Volitional exercises
Other Intervention Name(s)
Strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short Physical Performance Battery
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Muscle volume
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara R Piva, PT, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Department
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31197369
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.
Results Reference
derived
PubMed Identifier
29781580
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.
Results Reference
derived
PubMed Identifier
28482146
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.
Results Reference
derived

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

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