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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular electrical stimulation | Experimental | 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. |
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| Volitional exercises | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle volume | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara R Piva, PT, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Therapy Department | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31197369 | Derived | 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. | |
| 29781580 | Derived | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
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| Volitional exercises | Other | 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. |
|
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| 28482146 | Derived | 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |