NCT02308189

The Back Exercises to Neutralize Disability Study

Novel Exercise Interventions to Improve Trunk Muscle Function: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ohio University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a single-blinded, comparison-control group, single-center study of the effects of exercise with and without blood flow restriction applied to the appendicular limbs on safety, body composition (i.e., muscle mass), muscle strength, muscle endurance, whole body and regional lean mass and bone density, and back pain and disability in male and female subjects aged 18-50 years with recurrent low back pain and poor to moderate trunk extensor muscle endurance. Up to 50 subjects (2 arms) will be randomized in a 1:1 ratio to receive 10-weeks of resistance exercise training with (group 1) or without blood flow restriction (group 2). Randomization will be stratified by sex. This study will have a screening period of 21 days (day -21 to day -1, screening and baseline measures), a 10-week exercise treatment period (day 1 to day 70) and a 36-week follow up period after the last exercise session (day 70 to day 322). The total duration of the study from first exercise session will be approximately 46 weeks. Baseline measures for muscle size (via MRI), muscle strength, muscle endurance, whole body and regional lean mass and bone density (via DEXA), and measures of back pain and disability will be obtained between day -21 to -1. Primary Endpoint: The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training. Secondary: The secondary endpoints include: * Muscle strength * Muscle endurance (time to task failure) * Whole body and regional lean mass by DEXA * Whole body and regional bone density by DEXA * Pain * Disability * Safety * Treatment acceptability Procedures and Assessments Efficacy measures (MRI, muscle strength, muscle endurance, lean mass, bone density, pain, and disability) will be obtained at screening and at week 10 (day 70) and week 20 (day 154). Safety of blood flow restricted exercise will be assessed based on adverse event findings and monitoring. Subjects will be asked to monitor and report all adverse events (AEs) experienced from the time the informed consent is signed until the end-of-study visit. Treatment acceptability will be determined by administering the Treatment Evaluation Inventory survey at the end of the fourth and sixteenth exercise sessions.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Exercise with blood flow restriction	Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
BEHAVIORAL	Exercise	Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-11-24
• Completion: 2017-05-24
• First posted: 2014-12-04
• Last updated: 2018-06-19
• Results posted: 2018-06-19

Locations

1 site across 1 country: United States