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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- lower extremity strength
Study Overview
Brief Summary
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.
Detailed Description
This study is a randomized controlled trial to compare the effectiveness of low-intensity training with blood flow restriction (LIT+BFR) vs high-intensity training (HIT) vs a control group in people with RA, myositis, and osteoarthritis. Participants of each population will be randomized into LIT+BFR, HIT, or control. All functional testing and interventional procedures will be performed at the School of Allied Health Professions (SAHP). The evaluator will be blinded to group allocation. Blood draws and analysis will be performed during visits with the participant's rheumatologist at the Ambulatory Care Center, as part of the standard of care for their visits with their rheumatologist.
All participants will perform informed consent, which will take place at the SAHP Faculty Clinic. Once a participant has consented, he/she will participate in two familiarization sessions at least 48 hours apart. Familiarization sessions are designed to introduce patients to the exercise equipment, and will consist of the tests used in the evaluation portion of the intervention. Familiarization sessions also aide in better obtaining a patient's 1 repetition max (1RM, i.e. the maximum amount a person can lift one time) by decreasing the learning effect. It has a similar effect with the other functional or objective measures such as grip strength and pain-pressure threshold to decrease learning effect.
Once 1RM is determined (see 1RM test below), participants will be ranked in tertiles according to their 1RM in the leg press exercise and will then be randomly assigned to LIT+BFR, HIT, or control group. Randomization will be performed by Excel random generator. All participants will then undergo pre-testing that will include subjective questionnaires, and functional testing. Lab work will be performed by the rheumatologists as part of a participant's routine exam during the screening visit.
Investigators responsible for blood work and lab values will be blinded to participant allocation. A licensed and trained physical therapist, blinded to participant allocation, will be responsible for performing the functional tests. Testing will take a place on a separate day from the interventions. Due to the exercise-based intervention, participants will not be blinded to group allocation.
Prior to functional testing, each participant's blood pressure and heart rate will be measured to ensure safety with testing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The investigator responsible for outcomes assessment and evaluation will be blinded. The investigator performing statistical analysis will not be involved with any interventions or assessments prior to being provided data.
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
lower extremity strength
Time Frame: Lower extremity strength tests are performed at 0, 4, and 8 weeks, and should take 15-20 minutes to complete
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.
Functional Strength by the Timed-up-and-Go test
Time Frame: The Timed-up-and-Go will be performed at 0, 4, and 8 weeks and should take 2 minutes to complete.
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.
Gait Speed
Time Frame: Gait speed is performed at 0, 4, and 8 weeks and should take 2 minutes to complete.
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.
Health Assessment Questionnaire
Time Frame: 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.
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.
Cardiovascular endurance walking test
Time Frame: The 6 minute walk test is performed at 0, 4, and 8 weeks, and should take 6 minutes to complete.
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.
Secondary Outcomes
- Clinical Disease Activity Index (CDAI)(This assessment will be performed by the physician pre/post intervention, and should take 10 minutes to complete.)
- Grip Strength(Grip strength measurements are performed at 0, 4, and 8 weeks, and should take 2 minutes to complete)
- Pain Pressure Threshold(Pain pressure threshold will be measured one time per week, and is estimated to take 2 minutes to complete.)
- Self-Reported 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.)
- Numeric Pain Rating Scale(numeric pain rating scale will be rated at every participant encounter, and takes less than 1 minute to complete.)
- Self-Reported function in patients with hip osteoarthritis (OA)(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.)
- Self-Reported function in patients with knee osteoarthritis (OA)(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.)
- Self-Reported function in patients with foot and/or ankle osteoarthritis (OA)(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)
- Biceps muscle strength(Biceps strength tests are performed at 0, 4, and 8 weeks and should take 2 minutes to complete)