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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250262
• Other study ID #: 258-2010
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: February 12, 2014
• Start date: November 2010
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Obesity

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	UF&Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No