Rheumatoid ArthritisNCT00924625
The Use of Neuromuscular Electrical Stimulation to Reverse Muscle Atrophy in Patients With Rheumatoid Arthritis
A study testing Neuromuscular electrical stimulation and Volitional exercises in people with Rheumatoid Arthritis, run by University of Pittsburgh at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Neuromuscular electrical stimulation and Volitional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Therapy Department
Pittsburgh, Pennsylvania, 15260
About this study
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Neuromuscular electrical stimulation, Volitional exercises
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationOther
Also called 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 exercisesOther
Also called Strength training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neuromuscular electrical stimulation |
| 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 Receives: Other: Volitional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
Measured: 4 months
Secondary outcomes (1)
Muscle volume
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara R Piva, PT, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924625
- Sponsor's protocol ID
- K01HD058035-01
- Status last verified
- Sep 2014
- First submitted
- 18 Jun 2009
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31197369Piva 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.
PubMed 29781580Khoja 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.
PubMed 28482146
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Neuromuscular Electrical Stimulation to Reverse Muscle Atrophy in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00924625
- Acronym / sponsor ID
- K01HD058035-01
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | Other: Neuromuscular electrical stimulationNMES 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. |
| Volitional exercises | Active comparator | Other: Volitional exercisesVE 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationAlso: Electrical StimulationStrength 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. | Other | Neuromuscular electrical stimulation |
| Volitional exercisesAlso: Strength trainingThe 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. | Other | Volitional exercises |
Primary outcome
Short Physical Performance Battery
Time frame: 4 months
1 secondary outcome
Muscle volume
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
- Derived from this study: PubMed 31197369Almeida 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.
- Derived from this study: PubMed 29781580Piva 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.
- Derived from this study: PubMed 28482146Khoja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara R Piva, PT, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation and Volitional exercises in people with Rheumatoid Arthritis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924625, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.