Physical Activity for Older Adults Chronic Low Back Pain (PACe-LBP)
Physical Activity for Older Adults With Chronic Low Back Pain: PACe-LBP
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic low back pain (cLBP) is one of the most common and disabling conditions among US military Veterans, and the prevalence is rising even more rapidly than other chronic conditions such as diabetes and hypertension. Studies have shown that physical activity (PA) can improve outcomes in patients with cLBP, but a major gap in this research is the lack of studies focusing on older adults; patient samples have been primarily middle-aged and have included few patients' age 65 years. Therefore, the investigators' lack an evidence base for the feasibility and effectiveness of PA interventions in this vulnerable group of patients with cLBP. This is particularly important given the accumulating evidence showing that older adults with cLBP have significant lower extremity functional limitations, resulting in difficulty performing necessary daily tasks. Another area of limited investigation among older adults with cLBP is whether there is added benefit of incorporating cognitive behavioral therapy for pain management (CBT-P) skills with PA interventions. CBT-P can help to restructure pain perception and improve pacing of PA. Some patients with cLBP do not respond favorably to isolated PA interventions, and it is possible that heightened pain sensitization may underlie this lack of response in some patients. Since CBT-P has been shown to alter pain processing, older adults with cLBP who have greater pain sensitization may respond better to a program that combines PA and CBT-P (vs. PA alone); however, this has not been studied. This information has practical implications for a larger trial to determining whether a subset of patients with greater central pain sensitivity may need additional intervention to supplement a PA program.
The investigators will conduct a pilot study of a 12-week home-based PA and PA + CBT-P programs, both with weekly telephone support, compared with a waiting list control group. Participants will be 60 older Veterans (age 65) with cLBP. Enrollment of participants will occur via referrals from geriatric and primary care clinics at the Durham VAMC. The PA program will be comprehensive, including stretching, strengthening, and aerobic activities, and the specific types and intensities of the activities will be geared toward older adults. The CBT-P program will include five different skills, woven into the telephone-based sessions, with specific application to PA and cLBP. Both interventions will be jointly delivered by a physical therapist and exercise counselor, who has complementary areas of expertise (e.g., training in clinical exercise prescription and motivational interviewing skills to encourage PA adherence, respectively). Telephone calls will involve patient-specific goal-setting and address barriers to PA and CBT-P skills. Participants will receive a booklet with instructions and photographs for stretching and strengthening exercises, as well as an exercise video appropriate for older adults with cLBP. Participants in the combined intervention will also receive written and audio instructions regarding CBT-P skills. Feasibility measures will include the proportion of completed intervention calls, adherence to home-based PA recommendations and CBT-P skills use, and participant feedback on the programs. Outcomes will be assessed at baseline and 12-week follow-up. Primary measures of efficacy will be assessments of general physical function, both objective and self-reported (PROMIS Health Assessment Questionnaire). Secondary outcomes will include measures cLBP-specific pain and disability. Central pain sensitivity will be assessed via Pain Pressure Threshold (PPT) testing and the Central Sensitization Inventory (CSI). Statistical analyses will include comparison of baseline and follow-up outcomes across study groups, as well as examination of potential trends for differential intervention response according to baseline PPT and CSI scores.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VA Medical Center, Durham, NC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-report having had lower back pain on most days for greater than three months.
- Can complete a 10 second semi-tandem stand and walk 8' in 6.0 seconds.
- Report they are not satisfied with their current state of functional ability, based on reporting "dissatisfied" with at least one aspect of physical function on the Satisfaction with Physical Function Scale.
- Can safely participate in the intervention based upon the physical therapist baseline examination and clinical expertise.
Exclusion Criteria:
- unilateral or bilateral sciatica that physical therapist determines could make the study intervention unsafe or inappropriate; isolated coccyx pain (based on self-report at screener);
- dementia or other significant cognitive impairment;
- movement or motor neuron disorders (e.g., Parkinson's Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis);
- rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease;
- hospitalization for a stroke, myocardial infarction, heart failure, or coronary artery revascularization in the past 3 months;
- significant hearing impairment (must be able to talk on the telephone);
- psychosis or current, uncontrolled substance abuse disorder;
- any other health conditions determined by the study team to be contraindications to performing mild to moderate home exercises.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Activity Only
12-week home-based physical activity program with telephone support.
Delivered by a physical therapist and exercise counselor.
Comprehensive program including stretching, strengthening and aerobic activity.
|
12-week home-based physical activity program with telephone support.
Delivered by a physical therapist and exercise counselor.
Comprehensive program including stretching, strengthening and aerobic activity.
|
|
Experimental: Physical Activity + Cognitive Behavioral Therapy
12-week combined home-based physical activity and cognitive behavioral program with telephone support.
Delivered by a physical therapist and exercise counselor.
Comprehensive physical activity program including stretching, strengthening and aerobic activity.
Cognitive behavioral component includes training in multiple skills for managing pain.
|
12-week home-based physical activity program with telephone support.
Delivered by a physical therapist and exercise counselor.
Comprehensive program including stretching, strengthening and aerobic activity.
Telephone-based training in multiple skills for managing low back pain.
|
|
No Intervention: Wait List Control Group
Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Get-Up-And Go
Time Frame: Change from baseline to 12-week follow-up
|
This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair.
Greater number of seconds is associated with poorer physical function.
Therefore, a positive change from baseline to follow-up means worsening function; a negative change (e.g., lower score at follow-up than at baseline) indicated improving function.
|
Change from baseline to 12-week follow-up
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|
PROMIS Health Assessment Questionnaire
Time Frame: Change from baseline to 12-week follow-up
|
Self-reported physical function/disability measure that captures both activities of daily living and instrumental activities of daily living.
It consists of 20-items scored on a 0-3 scale with a summed 0-100-unit scale.
Higher scores are associated with worse function.
Therefore a positive change score indicates worsening over time; negative change score (e.g., lower score at follow-up) indicates improvement.
|
Change from baseline to 12-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Specific Functional Scale
Time Frame: Change from baseline to 12-week follow-up
|
This measure captures items that are specific functional tasks that may be missed on standardized questionnaires.
The measure consists of 3 items specifically provided by the patient.
Each item provided by the patient is score from a 0 (Unable to perform task) to 10 (able to complete the activity without difficulty) scale.
Higher change scores from baseline to follow up indicate more improvement (total range 0-30).
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Change from baseline to 12-week follow-up
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Roland-Morris Disease Specific Disability Questionnaire
Time Frame: Change from baseline to 12-week follow-up
|
24-item self-report measure of low back pain-specific disability.
Higher scores indicate worse function, with a range of 0=no disability to 24=maximum disability measured by the scale.
Therefore a positive change score indicates worsening.
A negative change score (e.g., lower score at follow-up) indicates improvement.
|
Change from baseline to 12-week follow-up
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|
Satisfaction With Physical Function Scale
Time Frame: Change from baseline to 12-week follow-up
|
This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying.
All items are rated on a 7-point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3).
A positive change score indicates improvement, and a negative change score indicates worsening.
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Change from baseline to 12-week follow-up
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1569-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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