Study Summary
This trial will compare the effects of two different exercise programs on people with rheumatoid arthritis, osteoarthritis, or myositis. One exercise program is traditional and high-intensity, while the other is low-intensity with blood flow restriction. There will also be a control group who does no exercise. All groups will be measured for strength, function, and patient outcomes before and after the 8-week program, and then again at 6 and 12 months.
Eligible Conditions
- Muscle Weakness
- Rheumatoid Arthritis
- Osteoarthritis
- Myositis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 9 Secondary · Reporting Duration: Grip strength measurements are performed at 0, 4, and 8 weeks, and should take 2 minutes to complete
Week 8
Biceps muscle strength
Week 8
Gait Speed
Week 8
Grip Strength
Week 8
lower extremity strength
Pain pressure threshold will be measured one time per week, and is estimated to take 2 minutes to complete.
Pain Pressure Threshold
Month 12
Self-Reported function
Week 8
Cardiovascular endurance walking test
Month 12
Self-Reported function in patients with foot and/or ankle osteoarthritis (OA)
Month 12
Health Assessment Questionnaire
Month 12
Self-Reported function in patients with hip osteoarthritis (OA)
Month 12
Self-Reported function in patients with knee osteoarthritis (OA)
Week 8
Functional Strength by the Timed-up-and-Go test
This assessment will be performed by the physician pre/post intervention, and should take 10 minutes to complete.
Clinical Disease Activity Index (CDAI)
numeric pain rating scale will be rated at every participant encounter, and takes less than 1 minute to complete.
Numeric Pain Rating Scale
Trial Safety
Safety Progress
Side Effects for
Walking Training
6%Diagnose Lung cancer
6%Diagnose aneurysm
Trial Design
3 Treatment Groups
Control
1 of 3
Traditional High-Intensity Training
1 of 3
Low Intensity plus Blood Flow Restriction Training
1 of 3
Active Control
Experimental Treatment
4 Total Participants · 3 Treatment Groups
Primary Treatment: Strength Training · No Placebo Group · N/A
Traditional High-Intensity Training
Other
Experimental Group · 1 Intervention: Strength Training · Intervention Types: OtherLow Intensity plus Blood Flow Restriction Training
Other
Experimental Group · 1 Intervention: Strength Training · Intervention Types: OtherControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: grip strength measurements are performed at 0, 4, and 8 weeks, and should take 2 minutes to complete
Who is running the clinical trial?
Louisiana State University Health Sciences Center ShreveportLead Sponsor
42 Previous Clinical Trials
14,102 Total Patients Enrolled
Erin McCallister, DPTPrincipal InvestigatorLSUHSC-Shreveport
1 Previous Clinical Trials
18 Total Patients Enrolled
Eligibility Criteria
Age 18 - 85 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Georgia | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| LSUHSC-Shreveport | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Rodrigues, Reynaldo, Rodrigo B. Ferraz, Ceci O. Kurimori, Lissiane K. Guedes, Fernanda R. Lima, Ana L. Sá‐Pinto, Bruno Gualano, and Hamilton Roschel. 2020. “Low‐load Resistance Training with Blood‐flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women with Rheumatoid Arthritis”. Arthritis Care & Research. Wiley. doi:10.1002/acr.23911.
- Takarada, Yudai, Haruo Takazawa, Yoshiaki Sato, Shigeo Takebayashi, Yasuhiro Tanaka, and Naokata Ishii. 2000. “Effects of Resistance Exercise Combined with Moderate Vascular Occlusion on Muscular Function in Humans”. Journal of Applied Physiology. American Physiological Society. doi:10.1152/jappl.2000.88.6.2097.
- Karabulut, Murat, Vanessa D. Sherk, Debra A. Bemben, and Michael G. Bemben. 2013. “Inflammation Marker, Damage Marker and Anabolic Hormone Responses to Resistance Training with Vascular Restriction in Older Males”. Clinical Physiology and Functional Imaging. Wiley. doi:10.1111/cpf.12044.
- Roschel, Hamilton, Manoel Neves-Junior, Bruno Gualano, Renato Barroso, Christiano Robles, Ana Lucia de Sá Pinto, Ricardo Fuller, and Fernanda Rodrigues Lima. 2011. “Familiarisation with Lower Limb Strength Testing in Middle-aged Women with Osteoarthritis of the Knee”. Physiotherapy. Elsevier BV. doi:10.1016/j.physio.2011.01.007.
- Mattar, Melina Andrade, Bruno Gualano, Luiz Augusto Perandini, Samuel Katsuyuki Shinjo, Fernanda Rodrigues Lima, Ana Lúcia Sá-Pinto, and Hamilton Roschel. 2014. “Safety and Possible Effects of Low-intensity Resistance Training Associated with Partial Blood Flow Restriction in Polymyositis and Dermatomyositis”. Arthritis Research & Therapy. Springer Science and Business Media LLC. doi:10.1186/s13075-014-0473-5.
- Santos, Audrei, Manuel Neves Jr, Bruno Gualano, Gilberto Laurentino, Antonio Lancha Jr, Carlos Ugrinowitsch, Fernanda Lima, and Marcelo Aoki. 2014. “Blood Flow Restricted Resistance Training Attenuates Myostatin Gene Expression in A Patient with Inclusion Body Myositis”. Biology of Sport. Index Copernicus. doi:10.5604/20831862.1097479.
- Gundermann, David M., Dillon K. Walker, Paul T. Reidy, Michael S. Borack, Jared M. Dickinson, Elena Volpi, and Blake B. Rasmussen. 2014. “Activation of Mtorc1 Signaling and Protein Synthesis in Human Muscle Following Blood Flow Restriction Exercise Is Inhibited by Rapamycin”. American Journal of Physiology-endocrinology and Metabolism. American Physiological Society. doi:10.1152/ajpendo.00600.2013.
- Abe T HS, Beekley MD, Koizumi K. Day-to-day change in muscle strength and MRI-measured skeletal muscle size during 7 days KAATSU resistance training: A case study. Int J KAATSU Train Res. 2005;1:71-76.
- Brown LE WJ. Accurate assessment of muscular strength and power. Journal of Exercise Physiology Online. 2001;4(1):1-21.
- Rodrigues, Reynaldo, Rodrigo B. Ferraz, Ceci O. Kurimori, Lissiane K. Guedes, Fernanda R. Lima, Ana L. Sá‐Pinto, Bruno Gualano, and Hamilton Roschel. 2020. “Low‐load Resistance Training with Blood‐flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women with Rheumatoid Arthritis”. Arthritis Care & Research. Wiley. doi:10.1002/acr.23911.
- Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
- Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sa-Pinto AL, Roschel H. Safety and possible effects of low-intensity resistance training associated with partial blood flow restriction in polymyositis and dermatomyositis. Arthritis Res Ther. 2014 Oct 25;16(5):473. doi: 10.1186/s13075-014-0473-5.
- Rodrigues R, Ferraz RB, Kurimori CO, Guedes LK, Lima FR, de Sa-Pinto AL, Gualano B, Roschel H. Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2020 Jun;72(6):787-797. doi: 10.1002/acr.23911. Epub 2020 May 14.
- Roschel H, Neves-Junior M, Gualano B, Barroso R, Robles C, de Sa Pinto AL, Fuller R, Lima FR. Familiarisation with lower limb strength testing in middle-aged women with osteoarthritis of the knee. Physiotherapy. 2011 Dec;97(4):350-3. doi: 10.1016/j.physio.2011.01.007. Epub 2011 Apr 15. No abstract available.
- 2021. "Comparison of Training Load With/Out Blood Flow Restriction Training in Rheumatoid Populations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04309227.
Frequently Asked Questions
Does this research include older adults as participants?
"This trial includes a wide age range of patients from 18 years old to 85 years old." - Anonymous Online Contributor
Unverified Answer
If a patient is interested, can they enroll in this clinical trial currently?
"This particular study is no longer recruiting patients, however, this was last updated on July 1st, 2022. According to the same source, there are 1070 other trials that are still recruiting." - Anonymous Online Contributor
Unverified Answer