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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01250262
First received: November 5, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Obesity
Other: normal medical care and follow up
Other: Isolated Lumbar Resistance Exercise Program
Other: Total Body Resistance Exercise Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months [ Time Frame: Baseline, 1, 2, 3 and 4 Months ] [ Designated as safety issue: No ]
    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.

  • Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months [ Time Frame: Baselinje, 1, 2, 3 and 4 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1, 2, 3 and 4 Months ] [ Designated as safety issue: No ]
    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.

  • Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months [ Time Frame: Baseline, 1, 2, 3 and 4 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1, 2, 3, and 4 Months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Graded Treadmill Exercise Test; Change from Baseline at 4 Months [ Time Frame: Baseline and 4 Months ] [ Designated as safety issue: No ]
    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.

  • Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months [ Time Frame: Baseline and 4 Months ] [ Designated as safety issue: No ]
    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.

  • 7-day Pedometer Test; Change from Baseline at 4 Months [ Time Frame: 7 day period at Baseline and 4 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 Months ] [ Designated as safety issue: No ]
    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.

  • Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months [ Time Frame: Baseline, 1, 2, 3 and 4 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 72
Study Start Date: November 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard care
Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
Other: normal medical care and follow up
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
Active Comparator: Isolated Lumbar Resistance Exercise Program
Lumbar extension exercise protocol to increase strength and reduce pain.
Other: Isolated Lumbar Resistance Exercise Program
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
Active Comparator: 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
Other: Total Body Resistance Exercise Program
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

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250262

Locations
United States, Florida
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Heather K Vincent, Ph.D. University of Florida Department of Orthopaedics and Rehabilitation
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01250262     History of Changes
Other Study ID Numbers: 258-2010
Study First Received: November 5, 2010
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
low back pain
obese
fear avoidance
disability and low back pain
chronic low back pain in obese older adults

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Obesity
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight

ClinicalTrials.gov processed this record on August 28, 2014