The Back Exercises to Neutralize Disability Study

NCT02308189 | Completed Results DMC

• 2 other identifiers: 14F0251R21AR063909
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Low Back Pain

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Trunk Extensor Muscle Cross Sectional Area % of Change

  The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by 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.

  Baseline and following 10-weeks of exercise training. Values are calculated from % change.

Secondary Outcomes (2)

• Muscle Strength % of Change

  Baseline and following 10-weeks of exercise training. Values calculated are % of change

• Muscle Endurance (Time to Task Failure) % of Change

  Baseline and following 10-weeks of exercise training. Values are calculated on % of change.

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Low load resistance exercise training

Behavioral: Exercise

Exercise with blood flow restriction

EXPERIMENTAL

Low load resistance exercise training with blood flow restriction

Behavioral: Exercise with blood flow restriction

Interventions

Exercise with blood flow restriction BEHAVIORAL

Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.

Also known as: Kaatsu Training with Blood Flow Restricted Exercise

Exercise with blood flow restriction

Exercise BEHAVIORAL

Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.

Also known as: Resistance exercise

Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Ohio University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (1)

• Amano S, Ludin AF, Clift R, Nakazawa M, Law TD, Rush LJ, Manini TM, Thomas JS, Russ DW, Clark BC. Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 12;17:81. doi: 10.1186/s13063-016-1214-7.

  PMID: 26867541 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Brian Clark, PhD
• Organization: Ohio University

clarkb2@ohio.edu

740-593-2354

Study Officials

• Brian C Clark, PhD

  Ohio Musculoskeletal and Neurological Institute (OMNI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2014
• Primary Completion: November 24, 2016
• Study Completion: May 24, 2017
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)