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

NCT01250262 | Completed

• 1 other identifier: 258-2010
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Obesity

Keywords

low back pain; obese; fear avoidance; disability and low back pain; chronic low back pain in obese older adults

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Secondary Outcomes (5)

• Graded Treadmill Exercise Test; Change from Baseline at 4 Months

  Baseline and 4 Months

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

  Baseline and 4 Months

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

  7 day period at Baseline and 4 Months

• Ultrasound Muscle Thickness; Change from Baseline at 4 Months

  Baseline and 4 Months

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

  Baseline, 1, 2, 3 and 4 Months

Study Arms (3)

Standard care

ACTIVE COMPARATOR

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

Isolated Lumbar Resistance Exercise Program

ACTIVE COMPARATOR

Lumbar extension exercise protocol to increase strength and reduce pain.

Other: Isolated Lumbar Resistance Exercise Program

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

Other: Total Body Resistance Exercise Program

Interventions

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

Standard care

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

Isolated Lumbar Resistance Exercise Program

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

Total Body Resistance Exercise Program

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Low Back Pain; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Heather K Vincent, Ph.D.

  University of Florida Department of Orthopaedics and Rehabilitation

  PRINCIPAL INVESTIGATOR

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: November 5, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (1)