Comparison of Training Load With/Out Blood Flow Restriction Training in Rheumatoid Populations

NCT04309227 | Terminated

• 1 other identifier: 00001312
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Myositis; Osteoarthritis; Weakness, Muscle

Keywords

rheumatoid arthritis; osteoarthritis; myositis; blood flow restriction; strength training; weight training

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

• 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.

• 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.

• 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 Outcomes (9)

• 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.

• 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

• Clinical Disease Activity Index (CDAI)

  This assessment will be performed by the physician pre/post intervention, and should take 10 minutes to complete.

Study Arms (3)

Traditional High-Intensity Training

EXPERIMENTAL

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.

Other: Strength Training

Low Intensity plus Blood Flow Restriction Training

EXPERIMENTAL

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.

Other: Strength Training

Control

NO 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.

Interventions

Strength Training OTHER

Strength training traditionally requires use of high intensity loads to stimulate muscle growth and strength improvements. Some participants will be randomized to a traditional strength training program. Blood Flow Restriction (BFR) training is used to stimulate muscle hypertrophy and strength improvements in a variety of populations. Results of BFR training are comparable to traditional high intensity training (HIT) despite using weight that are at a low intensity (low percent of 1 repetition maximum). This intervention has not been extensively studies in the rheumatoid or osteoarthritis populations, nor the myositis populations despite idealogical benefit for each group of low-load strengthening.

Low Intensity plus Blood Flow Restriction Training; Traditional High-Intensity Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

LSUHSC-Shreveport

Shreveport, Louisiana, 71103, United States

Location

Related Publications (9)

• 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.

  PMID: 31033228 BACKGROUND

• 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.

  PMID: 25344395 BACKGROUND

• Santos AR, Neves MT Jr, Gualano B, Laurentino GC, Lancha AH Jr, Ugrinowitsch C, Lima FR, Aoki MS. Blood flow restricted resistance training attenuates myostatin gene expression in a patient with inclusion body myositis. Biol Sport. 2014 Jun;31(2):121-4. doi: 10.5604/20831862.1097479. Epub 2014 Apr 5.

  PMID: 24899776 BACKGROUND

• 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.

  PMID: 24691032 BACKGROUND

• Karabulut M, Sherk VD, Bemben DA, Bemben MG. Inflammation marker, damage marker and anabolic hormone responses to resistance training with vascular restriction in older males. Clin Physiol Funct Imaging. 2013 Sep;33(5):393-9. doi: 10.1111/cpf.12044. Epub 2013 Apr 23.

  PMID: 23701309 BACKGROUND

• 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.

  PMID: 10846023 BACKGROUND

• 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.

  PMID: 22051593 BACKGROUND

• Brown LE WJ. Accurate assessment of muscular strength and power. Journal of Exercise Physiology Online. 2001;4(1):1-21.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Myositis; Osteoarthritis; Muscle Weakness

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Erin McCallister, DPT

  LSUHSC-Shreveport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 16, 2020
• Study Start: May 1, 2021
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: January 22, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)