The Back Exercises to Neutralize Disability Study

Completed · Not applicable

Conditions studied: Low Back Pain

In brief

A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and endurance, whole body and regional lean mass and bone density, as well as the rate of recurrence of LBP (secondary outcomes).

Key facts

Study ID

NCT02308189

Run by

Ohio University

People needed

32

Starts

2014-12-01

Expected to finish

2017-05-24

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18 to 50 years, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study per protocol or that would impact the capability to get an accurate measurement of study endpoints.
• Answer yes to the following question: Have you had two or more episodes of low back pain in the past 12-months with at least one of the episodes causing a restriction of work or leisure time activity?
• Exhibit low trunk extensor endurance defined as the time to task failure during the modified-Sorenson test of less than 176 seconds.
• Body mass index (BMI) between 19 and 37 kg/m2 inclusive.
• With no condition that could limit participation in supervised resistance training exercise based on the Physical Activity Readiness Questionnaire (PAR-Q) (i.e., if a study participant answers yes to questions 1-4 they will be excluded, if they answer yes to 5-7 they will require clearance for participation by the study physician).
• Sedentary lifestyle defined by a classification of "low" or "moderate" levels of physical activity based on the scoring criteria for the International Physical Activity Questionnaire (IPAQ).
• Willing to maintain current diet and adhere to exercise programs described for the study and to not start any new dieting/weight management programs.
• Willing and able to return for all clinic visits and complete all study-related procedures.
• Able to read, understand, and complete study-related questionnaires
• Able to read and understand, and willing to sign the informed consent form (ICF).

You may not qualify if…

• Participation in progressive resistance exercise within the previous 24 weeks prior to screening.
• Participation in any clinical trial within 24 weeks prior to screening.
• Hospitalization (medical confinement for ≥24 hours), or immobilization, or major surgical procedure requiring general anesthesia within 24 weeks prior to screening, or any planned surgical procedures during the study period.
• Limb amputation (except for toes) and/or any fracture within 24 weeks.
• Osteoarthritis, rheumatologic diseases or orthopedic disorders which will not allow completion of the motions required for the resistance exercise.
• Conditions (such as myasthenia gravis, myositis, muscular dystrophy or myopathy, including drug-induced myopathy) leading to muscle loss, muscle weakness, muscle cramps or myalgia.
• Chronic or relapsing/remitting gastrointestinal disorders such as inflammatory bowel diseases, irritable bowel syndrome or gastrointestinal infections within 28 days of screening.
• Acute viral or bacterial upper or lower respiratory infection at screening
• Moderate or severe chronic obstructive pulmonary disease.
• Back pain greater than 4 (on a 10 point numeric pain rating scale) at screening
• Leg length discrepancy > 3 cm.
• Current or recent (i.e., within 12 weeks) of narcotics or muscle relaxants.
• Currently pregnant (confirmed via a urine test) or planning to become pregnant within the next year at screening.
• Report unexplained weight loss over the past 30 days (> 10 pounds).
• Report having pending litigation related to low back pain or currently receiving disability for low back pain.
• Report having received treatment for low back pain from a health care practitioner in the past 6 weeks.
• History of spine surgery or hip arthroplasty.
• Cancer requiring treatment currently or in the past 3 years (except primary non-melanoma skin cancer or in situ cervical cancer)
• Moderate or severe asthma with current or recurring symptoms within the last 1-year.
• Known history of human immunodeficiency virus (HIV) antibody and/or positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis C antibody (HCV) at screening.
• Neurological conditions resulting in impaired muscle function or mobility (e.g., stroke with residual paresis, paralysis, multiple sclerosis, or Parkinson Disease).
• Psychiatric conditions that warrant acute or chronic therapeutic intervention (e.g., major depressive disorder, bipolar disorder, panic disorder, schizophrenia) that in the investigators opinion may interfere with the conduct of study procedures
• History of cardiac conditions such as heart failure (NYHA class II-IV), angina (including unstable angina), myocardial infarction, cardiomyopathy, any cardiac arrhythmia (except stable sinus dysrhythmia or atrial fibrillation) or valvular heart disease (except asymptomatic mitral valve prolapse).
• History of peripheral vascular disease.
• Subjects with the following abnormal ECG findings at screening will be excluded:

Where it is running

• Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University — Athens, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.