Clinical trial NCT01250262: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: 10 centimeter Visual Analog Scale (VAS); Change from Baseline at 1, 2, 3 and 4 Months
timeFrame: Baseline, 1, 2, 3 and 4 Months
measure: Tampa Scale of Kinesiophobia (TSK); Change from Baseline at 1, 2, 3 and 4 Months
timeFrame: Baseline, 1, 2, 3 and 4 Months
measure: Fear-Avoidance Beliefs Questionnaire (FABQ); Change from Baseline at 1, 2, 3 and 4 Months
timeFrame: Baselinje, 1, 2, 3 and 4 Months
measure: Pain Catastrophizing Scale (PCS); Change from Baseline at 1, 2, 3 and 4 Months
timeFrame: Baseline, 1, 2, 3 and 4 Months
measure: Modified Oswestry Disability Index (ODI); Change from Baseline at 1, 2, 3 and 4 Months
timeFrame: Baseline, 1, 2, 3 and 4 Months
measure: Roland Disability Survey (RDS); Change from Baseline at 1, 2, 3 and 4 Months
timeFrame: Baseline, 1, 2, 3, and 4 Months
Secondary outcomes:
measure: Graded Treadmill Exercise Test; Change from Baseline at 4 Months
timeFrame: Baseline and 4 Months
measure: Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months
timeFrame: Baseline and 4 Months
measure: 7-day Pedometer Test; Change from Baseline at 4 Months
timeFrame: 7 day period at Baseline and 4 Months
measure: Ultrasound Muscle Thickness; Change from Baseline at 4 Months
timeFrame: Baseline and 4 Months
measure: Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months
timeFrame: Baseline, 1, 2, 3 and 4 Months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida Department of Orthopaedics and Rehabilitation
name: Heather K Vincent, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: