Skip to main content
OpenTrials
Completed

NCT Number: NCT01250262

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

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

Primary outcomes

  1. 10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months

    Time frame: 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.

  2. Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months

    Time frame: 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.

  3. Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months

    Time frame: 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.

  4. Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months

    Time frame: 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.

  5. Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months

    Time frame: 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.

  6. Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months

    Time frame: 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.

Secondary outcomes

  1. Graded Treadmill Exercise Test; Change from Baseline at 4 Months

    Time frame: 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.

  2. Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months

    Time frame: 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.

  3. 7-day Pedometer Test; Change from Baseline at 4 Months

    Time frame: 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.

  4. Ultrasound Muscle Thickness; Change from Baseline at 4 Months

    Time frame: 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.

  5. Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2010
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.