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Behavioural Intervention
Strength Training with Blood Flow Restriction for Rheumatoid Arthritis
N/A
Waitlist Available
Led By Erin McCallister, DPT
Research Sponsored by Louisiana State University Health Sciences Center Shreveport
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for individuals with rheumatoid arthritis, osteoarthritis, or myositis who have been on stable medication for at least 3 months and are cleared by a rheumatologist to participate in high-intensity training. They should not have cardiovascular diseases that prevent exercise, recent regular physical activity training, joint replacements in weight-bearing joints, high prednisone use, or inability to perform basic mobility tests.
What is being tested?
The study compares traditional high-intensity strength training against low-intensity strength training with blood flow restriction. There's also a control group receiving no training. Participants' strength and function will be measured before the program starts, midway through it, at the end of the 8-week program and again after 6 and 12 months.
What are the potential side effects?
While specific side effects aren't listed here since this is about exercise interventions rather than drugs; participants may experience muscle soreness or fatigue due to high-intensity workouts or discomfort from blood flow restriction bands.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the 6 minute walk test is performed at 0, 4, and 8 weeks, and should take 6 minutes to complete.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the 6 minute walk test is performed at 0, 4, and 8 weeks, and should take 6 minutes to complete.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cardiovascular endurance walking test
Functional Strength by the Timed-up-and-Go test
Gait Speed
+2 moreSecondary study objectives
Biceps muscle strength
Clinical Disease Activity Index (CDAI)
Grip Strength
+6 moreSide effects data
From 2008 Phase 3 trial • 34 Patients • NCT008796976%
Gastrointestinal problems
6%
Inguinal hernia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Strength Training
Walking Training
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Traditional High-Intensity TrainingExperimental Treatment1 Intervention
Participants will perform their training at \~70% of their 1-repetition maximum, as traditionally advocated in strengthening literature. Each of the diagnoses (RA, OA, myositis) will have a High-Intensity arm.
Group II: Low Intensity plus Blood Flow Restriction TrainingExperimental Treatment1 Intervention
Participants will perform their training at \~30% of their 1-repetition maximum, and will have blood flow partially occluded (60-70%) to the training limb. Each of the diagnoses (RA, OA, myositis) will have a Low-Intensity plus Blood Flow Restriction arm.
Group III: ControlActive Control1 Intervention
Each of the diagnoses (RA, OA, myositis) will have a control arm. The control groups will be evaluated at time 0, 4 weeks, and 8 weeks but will not receive intervention.
Find a Location
Who is running the clinical trial?
Louisiana State University Health Sciences Center ShreveportLead Sponsor
49 Previous Clinical Trials
17,395 Total Patients Enrolled
1 Trials studying Muscle Weakness
12 Patients Enrolled for Muscle Weakness
Erin McCallister, DPTPrincipal InvestigatorLSUHSC-Shreveport
4 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Muscle Weakness
12 Patients Enrolled for Muscle Weakness
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart condition or other health issues that make it hard for you to exercise.You have been doing regular exercise or physical therapy in the past 6 months.You have osteoarthritis in joints that support your weight, but it's not at an advanced stage according to the Kellgren Lawrence grading system.You have had joint replacement surgery in weight-bearing joints.You have taken more than 5mg of prednisone in the last 3 months.You need more than a little help to do certain walking tests like the timed up and go test, 10 meter walk test, or 6 minute walk test, but you can use assistive devices if needed.You have been diagnosed with rheumatoid arthritis, osteoarthritis, or myositis by a specific doctor at LSUHSC-Shreveport.The text states that the person has been cleared by a rheumatologist to participate in high intensity training and blood flow restriction training.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Traditional High-Intensity Training
- Group 3: Low Intensity plus Blood Flow Restriction Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Muscle Weakness Patient Testimony for trial: Trial Name: NCT04309227 — N/A
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