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

Primary Purpose

Low Back Pain, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
normal medical care and follow up
Isolated Lumbar Resistance Exercise Program
Total Body Resistance Exercise Program
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, obese, fear avoidance, disability and low back pain, chronic low back pain in obese older adults

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UF&Shands Orthopaedics and Sports Medicine Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard care

Isolated Lumbar Resistance Exercise Program

Total Body Resistance Exercise Program

Arm Description

Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.

Lumbar extension exercise protocol to increase strength and reduce pain.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 5, 2010
Last Updated
February 12, 2014
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01250262
Brief Title
Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain
Official Title
Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Obesity
Keywords
low back pain, obese, fear avoidance, disability and low back pain, chronic low back pain in obese older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Subjects will receive normal medical care and follow up during the four month study period if assigned to this group.
Arm Title
Isolated Lumbar Resistance Exercise Program
Arm Type
Active Comparator
Arm Description
Lumbar extension exercise protocol to increase strength and reduce pain.
Arm Title
Total Body Resistance Exercise Program
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
normal medical care and follow up
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Isolated Lumbar Resistance Exercise Program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Total Body Resistance Exercise Program
Intervention Description
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 Outcome Measure Information:
Title
10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
Description
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.
Time Frame
Baseline, 1, 2, 3 and 4 Months
Title
Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
Description
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.
Time Frame
Baseline, 1, 2, 3 and 4 Months
Title
Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months
Description
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.
Time Frame
Baselinje, 1, 2, 3 and 4 Months
Title
Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months
Description
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.
Time Frame
Baseline, 1, 2, 3 and 4 Months
Title
Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months
Description
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.
Time Frame
Baseline, 1, 2, 3 and 4 Months
Title
Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months
Description
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.
Time Frame
Baseline, 1, 2, 3, and 4 Months
Secondary Outcome Measure Information:
Title
Graded Treadmill Exercise Test; Change from Baseline at 4 Months
Description
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.
Time Frame
Baseline and 4 Months
Title
Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months
Description
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.
Time Frame
Baseline and 4 Months
Title
7-day Pedometer Test; Change from Baseline at 4 Months
Description
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.
Time Frame
7 day period at Baseline and 4 Months
Title
Ultrasound Muscle Thickness; Change from Baseline at 4 Months
Description
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.
Time Frame
Baseline and 4 Months
Title
Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months
Description
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.
Time Frame
Baseline, 1, 2, 3 and 4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather K Vincent, Ph.D.
Organizational Affiliation
University of Florida Department of Orthopaedics and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF&Shands Orthopaedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States

12. IPD Sharing Statement

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

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