Low Back PainNCT01250262
Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain
A study testing normal medical care and follow up, Isolated Lumbar Resistance Exercise Program and Total Body Resistance Exercise Program in people with Low Back Pain and Obesity, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Low Back Pain, Obesity
- What is being tested?
- normal medical care and follow up, Isolated Lumbar Resistance Exercise Program and Total Body Resistance Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain
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
- Being tested
- normal medical care and follow up, Isolated Lumbar Resistance Exercise Program, Total Body Resistance Exercise Program
- Keywords
- low back pain, obese, fear avoidance, disability and low back pain, chronic low back pain in obese older adults
- Medical subject headings
- Low Back Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal medical care and follow upOther
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 ProgramOther
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 ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Subjects will receive normal medical care and follow up during the four month study period if assigned to this group. Receives: Other: normal medical care and follow up |
| Isolated Lumbar Resistance Exercise Program | Active comparator | Lumbar extension exercise protocol to increase strength and reduce pain. Receives: 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 Receives: Other: Total Body Resistance Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1, 2, 3, and 4 Months
Secondary outcomes (5)
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.
Measured: Baseline and 4 Months
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.
Measured: Baseline and 4 Months
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.
Measured: 7 day period at Baseline and 4 Months
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.
Measured: Baseline and 4 Months
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.
Measured: Baseline, 1, 2, 3 and 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather K Vincent, Ph.D., Principal investigator, University of Florida Department of Orthopaedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250262
- Sponsor's protocol ID
- 258-2010
- Status last verified
- Feb 2014
- First submitted
- 5 Nov 2010
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise Effects on Fear Avoidance Beliefs and Physical Function in Obese, Older Adults With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01250262
- Acronym / sponsor ID
- 258-2010
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: normal medical care and follow upSubjects will receive normal medical care and follow up during the four month study period if assigned to this group. |
| Isolated Lumbar Resistance Exercise Program | Active comparator | Other: Isolated Lumbar Resistance Exercise ProgramLumbar extension exercise protocol to increase strength and reduce pain. |
| Total Body Resistance Exercise Program | Active comparator | Other: Total Body Resistance Exercise ProgramTraining 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 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal medical care and follow upphysical 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 | Other | Standard care |
| Isolated Lumbar Resistance Exercise Programlumbar 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 | Other | Isolated Lumbar Resistance Exercise Program |
| Total Body Resistance Exercise Programexercises: 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 | Other | Total Body Resistance Exercise Program |
Primary outcome
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
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
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
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
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
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
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.
5 secondary outcomes
Graded Treadmill Exercise Test; Change from Baseline at 4 Months
Time frame: Baseline and 4 Months
Chair Rise Time, Stair Climb Time and Gait Assessment; Change from Baseline at 4 Months
Time frame: Baseline and 4 Months
7-day Pedometer Test; Change from Baseline at 4 Months
Time frame: 7 day period at Baseline and 4 Months
Ultrasound Muscle Thickness; Change from Baseline at 4 Months
Time frame: Baseline and 4 Months
Muscle Strength; Change from Baseline at 1, 2, 3 and 4 Months
Time frame: Baseline, 1, 2, 3 and 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Related trials for Low Back Pain
Recruiting
Conventional vs Pulsed RF in Coccydynia
Back Pain
Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather K Vincent, Ph.D. principal investigator
University of Florida Department of Orthopaedics and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal medical care and follow up, Isolated Lumbar Resistance Exercise Program and Total Body Resistance Exercise Program in people with Low Back Pain and Obesity, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.