Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain

Not Applicable

Completed

• Conditions: Obesity; Low Back Pain
• Interventions: Other: Isolated Lumbar Resistance Exercise Program; Other: normal medical care and follow up; Other: Total Body Resistance Exercise Program

• Registration Number: NCT01250262
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• chronic low back pain for >6 months
• >3 pain episodes per week
• waist circumferences ≥102 cm for men
• waist circumferences ≥ 88 cm for women
• willing and able to participate in regular exercise for 14 weeks
• using pain medications to control low back pain
• free of abnormal cardiovascular responses during a screening graded maximal walk test

Exclusion Criteria

• unable to walk
• participating in regular resistance exercise training (>3X week) in the past 6 months
• pain symptoms are too severe and prevent strength testing or walking
• acute back injury
• spinal stenosis that precludes walking one block due to neurogenic claudication
• back surgery within the past 2 years
• current use of weight loss interventions (drugs; exercise interventions)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isolated Lumbar Resistance Exercise Program	Isolated Lumbar Resistance Exercise Program	Lumbar extension exercise protocol to increase strength and reduce pain.
Standard care	normal medical care and follow up	Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
Total Body Resistance Exercise Program	Total Body Resistance Exercise Program	Training protocol for 1 set for each exercise: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl

Primary Outcome Measures

Name	Time	Method
Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months	Baseline, 1, 2, 3 and 4 Months	Fear avoidance beliefs will be measured using the 11 item TSK. Subjects will complete the TSK at the indicated time intervals to document any change in their fear avoidance beliefs.
10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months	Baseline, 1, 2, 3 and 4 Months	The VAS scale will range from 0-10 cm, where a rating of "0" reflects no pain, and a "10" rating represents "worst pain imaginable. Subjects will complete the VAS at the indicated time intervals to document any change in their pain levels.
Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months	Baseline, 1, 2, 3 and 4 Months	The ODI is responsive to intervention treatments for low back pain, is reliable, and corresponds well with several global patient disability measures. Subjects will complete the ODI at the indicated time intervals to document any change in their low back pain.
Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months	Baseline, 1, 2, 3, and 4 Months	The RDS assesses physical disability and mental function with low back pain; this survey is sensitive to treatment interventions, and is reproducible and consistent and correlated well with other global ratings and disability measures. Subjects will complete the RDS at the indicated time intervals to document any change in their physical disability and mental function with their low back pain.
Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months	Baselinje, 1, 2, 3 and 4 Months	The FABQ is a tool based on theories of fear and avoidance behavior and focuses specifically on beliefs about how physical activity and work affect low back pain. Subjects will complete the FABQ at the indicated time intervals to document any change in their fear and avoidance behavior.
Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months	Baseline, 1, 2, 3 and 4 Months	The PCS will be used to assess the effect of the chronic back pain on rumination on pain symptoms and helplessness. Subjects will complete the PCS at the indicated time intervals to document any change in their thoughts of their pain symptoms.

Secondary Outcome Measures

Name	Time	Method
7-day Pedometer Test; Change from Baseline at 4 Months	7 day period at Baseline and 4 Months	Community ambulation will be estimated using a 7-day pedometer test in which participants will wear a StepWatch® step activity monitor. Subjects will complete this test at the indicated time intervals to document any change in their ambulation.
Ultrasound Muscle Thickness; Change from Baseline at 4 Months	Baseline and 4 Months	The ultrasound technique that will be used to capture muscle thickness changes in the paraspinal and multifidus muscles. Subjects will be tested at the indicated time intervals to document any change.
Graded Treadmill Exercise Test; Change from Baseline at 4 Months	Baseline and 4 Months	Maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test. Subjects will complete the exercise test at the indicated time intervals to document any change in their aerobic fitness.
Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months	Baseline, 1, 2, 3 and 4 Months	Assessments of strength (1 repetition maximum, 1-RM) will be determined for all muscle groups trained. Subjects will be assessed at the indicated time intervals to document any change.
Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months	Baseline and 4 Months	Chair rise time will be measured as the participant moves from a sitting to a full standing position. The time to walk up one flight of stairs will be measured by having the participants walk up one flight of stairs consisting of 12 steps as quickly as possible. Gait will be assessed by having the participants walk across a 26' portable walkway. Subjects will complete these motions at the indicated time intervals to document any change.

Trial Locations

Locations (1)

UF&Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States