Rheumatoid Arthritis Clinical Trial
Official title:
Comparison of Traditional High-Load Training With Low-Load Plus Blood Flow Restriction Training on Strength, Function, and Self-Reported Outcomes in Patients With Rheumatoid Disorders
NCT number | NCT04309227 |
Other study ID # | 00001312 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | August 23, 2023 |
Verified date | October 2023 |
Source | Louisiana State University Health Sciences Center Shreveport |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will investigate the effects of a traditional, high-intensity strengthening program compared to an investigational low-intensity strengthening program that also uses blood flow restriction as part of the training program. Both groups will be compared to a control group, which will receive no training. Measures of strength, function, and patient outcomes will be taken before starting the training, at mid-term, and at the end of the 8-week training program. Additionally, investigators will collect outcome data at 6 and 12 months after completing the program to assess for long term outcomes. The eligible populations are participants with rheumatoid arthritis (RA), osteoarthritis (OA), or myositis. The study will include about 15 participants per group, or 45 people with each diagnosis.
Status | Terminated |
Enrollment | 4 |
Est. completion date | August 23, 2023 |
Est. primary completion date | August 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - diagnosis from LSUHSC-SHreveport Rheumatologist of rheumatoid arthritis (RA), osteoarthritis (OA), or myositis - stable medication for at least 3 months - OA in weightbearing joints, and limited to non-advanced OA per Kellgren Lawrence grading - cleared by rheumatologist for participation in high intensity training and blood flow restriction training Exclusion Criteria: - cardiovascular or other disease preventing exercise participation - within past 6 months, have performed regular physical activity training or physical therapy - one or more arthroplasty in weight-bearing joints - taking more then 5mg of prednisone in past 3 months - unable to perform timed up and go test, 10 meter walk test, or 6 minute walk test without more than supervision assistance; assistive devices can be used |
Country | Name | City | State |
---|---|---|---|
United States | LSUHSC-Shreveport | Shreveport | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Louisiana State University Health Sciences Center Shreveport |
United States,
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.
Gundermann DM, Walker DK, Reidy PT, Borack MS, Dickinson JM, Volpi E, Rasmussen BB. Activation of mTORC1 signaling and protein synthesis in human muscle following blood flow restriction exercise is inhibited by rapamycin. Am J Physiol Endocrinol Metab. 2014 May 15;306(10):E1198-204. doi: 10.1152/ajpendo.00600.2013. Epub 2014 Apr 1. — View Citation
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lower extremity strength | Participant's leg strength will be measured by performing a one-repetition maximum lift on both the leg press and leg extension machines. This will be measured at the start of the study, and reassessed with a percent change determined at 4 and 8 weeks. The leg strength measurements will be used to set the weight used during exercise interventions. | Lower extremity strength tests are performed at 0, 4, and 8 weeks, and should take 15-20 minutes to complete | |
Primary | Functional Strength by the Timed-up-and-Go test | Participants will perform the Timed-up-and-Go test, which consists of standing up from a chair, walking a short distance, turning, and returning to the chair. Participants are timed on how long this task takes, and it has been validated as a measure of functional leg strength and balance. The test will be performed when starting the study, and reassessed at 4 and 8 weeks. | The Timed-up-and-Go will be performed at 0, 4, and 8 weeks and should take 2 minutes to complete. | |
Primary | Gait Speed | Participants will be timed on how quickly they are able to walk 10 meters, which will be used to calculate their gait speed in meters per second. The test will be performed when starting the study, and reassessed at 4 and 8 weeks. | Gait speed is performed at 0, 4, and 8 weeks and should take 2 minutes to complete. | |
Primary | Health Assessment Questionnaire | The Health Assessment Questionnaire (HAQ) asks a series of questions regarding how participants view their health. Each question is rated from 0-3, with a higher score indicating higher levels of disability. The HAQ is used in this study to investigate changes in self-perceived health status. It will be given on initial visit, and repeated at 4 and 8 weeks. It will be given again as part of the long-term follow-up at 6 and 12 months post-intervention. | The HAQ is performed at 0, 4, and 8 weeks; repeated 6 and 12 months post-intervention, and should take 10-20 minutes to complete. | |
Primary | Cardiovascular endurance walking test | Participants will perform the 6-minute walk test as a measure of cardiovascular endurance. The test involves walking a track for 6 minutes, with instructions to walk as fast as possible for the whole 6 minutes. Distance walked will be recorded and compared to normal values. The test will be performed when starting the study, and reassessed at 4 and 8 weeks. | The 6 minute walk test is performed at 0, 4, and 8 weeks, and should take 6 minutes to complete. | |
Secondary | Self-Reported function | Short Form-36 questionnaire will also be used to measure overall self-reported function. The Short Form-36 questionnaire has 8 sub-scales examining different aspects of function, with each sub-scale scored 0-100. A higher score indicates better function. | Short Form-36 is completed at 0, 4, and 8 weeks; repeated 6 and 12 months post-intervention. It should take 10-20 minutes to complete. | |
Secondary | Self-Reported function in patients with hip osteoarthritis (OA) | The Hip Osteoarthritis Outcome Score (HOOS) examines self-reported function related to osteoarthritis symptoms in the hip. It is scored from 0-100, with a higher score indicating better function. The test will be performed when starting the study, and reassessed at 4 and 8 weeks, and then at long-term follow up at 6 and 12 months post-intervention. A change score will be calculated with each reassessment. | The HOOS is completed at 0, 4, and 8 weeks; repeated 6 and 12 months post-intervention. It should take 10-20 minutes to complete. | |
Secondary | Self-Reported function in patients with knee osteoarthritis (OA) | The Knee Osteoarthritis Outcome Score (KOOS) examines self-reported function related to osteoarthritis symptoms in the knee. It is scored from 0-100, with a higher score indicating better function. The test will be performed when starting the study, and reassessed at 4 and 8 weeks, and then at long-term follow up at 6 and 12 months post-intervention. A change score will be calculated with each re-assessment. | The KOOS is completed at 0, 4, and 8 weeks; repeated 6 and 12 months post-intervention. It should take 10-20 minutes to complete. | |
Secondary | Self-Reported function in patients with foot and/or ankle osteoarthritis (OA) | The Foot and Ankle Outcome Score examines self-reported function related to osteoarthritis symptoms in the foot and/or ankle. It is scored from 0-100, with a higher score indicating better function. The test will be performed when starting the study, and reassessed at 4 and 8 weeks, and then at long-term follow up at 6 and 12 months post-intervention. A change score will be calculated with each re-assessment. | The Foot and Ankle Outcome Score is completed at 0, 4, and 8 weeks; repeated 6 and 12 months post-intervention. The Foot and Ankle Outcome Score | |
Secondary | Clinical Disease Activity Index (CDAI) | The CDAI is completed by the rheumatologist for participants with rheumatoid arthritis only. It will assess the number of tender and swollen joints, the patient's global score of disease activity, and the physician's global assessment of disease activity. One composite score is calculated, with a high score of 76 indicating high disease activity and a low score of 0 indicating remission. | This assessment will be performed by the physician pre/post intervention, and should take 10 minutes to complete. | |
Secondary | Biceps muscle strength | Biceps strength will be measured using a hand-held dynamometer, which measures how much force the participant is able to resist using their biceps muscle. Biceps strength will be tested when the participant initially starts the study, and then reassessed at 4 and 8 weeks. At each reassessment, a percent change in biceps strength will be calculated. | Biceps strength tests are performed at 0, 4, and 8 weeks and should take 2 minutes to complete | |
Secondary | Grip Strength | Grip strength will be measured using a dynamometer that measures how strong the participant is able to squeeze the dynamometer. Biceps strength will be tested when the participant initially starts the study, and then reassessed at 4 and 8 weeks. At each reassessment, a percent change in biceps strength will be calculated. | Grip strength measurements are performed at 0, 4, and 8 weeks, and should take 2 minutes to complete | |
Secondary | Numeric Pain Rating Scale | Pain will be assessed using the numeric pain rating scale. Scores range from 0-10, with higher scores indicating higher levels of pain. | numeric pain rating scale will be rated at every participant encounter, and takes less than 1 minute to complete. | |
Secondary | Pain Pressure Threshold | The Pain Pressure Threshold is measured by gradually applying more pressure to an area of the skin using a pressure algometer. The participant is instructed to report when the sensation changes from pressure to pain. The pounds of pressure applied is measured with the algometer and recorded. This measurement will be assessed at the upper extremity along the distal forearm, and lower extremity at the proximal anterior tibialis muscle. | Pain pressure threshold will be measured one time per week, and is estimated to take 2 minutes to complete. |
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