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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Subjects will receive normal medical care and follow up during the four month study period if assigned to this group. |
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| Isolated Lumbar Resistance Exercise Program | Active Comparator | Lumbar extension exercise protocol to increase strength and reduce pain. |
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| Total Body Resistance Exercise Program | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal medical care and follow up | Other | physical activity/ nutrition guidelines will be provided and reviewed with the participant as part of standard care; telephone contact will be made weekly to encourage adherence to the health guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| 10 centimeter Visual Analog Scale (VAS); Change from Baseline at 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. | Baseline, 1, 2, 3 and 4 Months |
| Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 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. | Baseline, 1, 2, 3 and 4 Months |
| Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 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. | Baselinje, 1, 2, 3 and 4 Months |
| Pain Catastrophizing Scale (PCS); Change from Baseline at 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. | Baseline, 1, 2, 3 and 4 Months |
| Modified Oswestry Disability Index (ODI); Change from Baseline at 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Graded Treadmill Exercise Test; Change from Baseline at 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. | Baseline and 4 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather K Vincent, Ph.D. | University of Florida Department of Orthopaedics and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF&Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida | 32607 | United States |
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| Isolated Lumbar Resistance Exercise Program | Other | lumbar extension, two set of 10-15 repetitions, once a week for two weeks; lumbar extension, one set of 10-15 repetitions, three times a week, week 3 to 4 months |
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| Total Body Resistance Exercise Program | Other | exercises: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl, one set of 10-12 repetitions, three time per week, week one to 4 months |
|
| Baseline, 1, 2, 3 and 4 Months |
| Roland Disability Survey (RDS); Change from Baseline at 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. | Baseline, 1, 2, 3, and 4 Months |
| Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 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. |
| Baseline and 4 Months |
| 7-day Pedometer Test; Change from Baseline at 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. | 7 day period at Baseline and 4 Months |
| Ultrasound Muscle Thickness; Change from Baseline at 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. | Baseline and 4 Months |
| Muscle Strength; Change from Baseline at 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. | Baseline, 1, 2, 3 and 4 Months |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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