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Physical Activity for Older Adults Chronic Low Back Pain

Physical Activity for Older Adults With Chronic Low Back Pain: PACe-LBP

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02327325
Acronym
PACe-LBP
Enrollment
60
Registered
2014-12-30
Start date
2015-05-21
Completion date
2017-03-01
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low Back Pain, Exercise, Cognitive Behavioral Therapy, Aged

Brief summary

Chronic low back pain (cLBP) is one of the most common and disabling conditions among US military Veterans. Although physical activity can improve cLBP outcomes, the majority of Veterans with cLBP are inactive. Therefore the VA is in need of effective programs that can help older Veterans with cLBP to increase their physical activity and improve associated outcomes. This is particularly relevant for older Veterans with cLBP who are at greater risk for functional limitations. The proposed project will be a pilot study of a telephone-based physical activity program or physical activity combined with cognitive behavioral pain management for older adult Veterans with cLBP. Older Veterans are of particular interest because prior studies of physical activity for cLBP have not addressed this vulnerable patient group. This study will also inform the VA about whether certain patients with cLBP, who have greater pain sensitivity, may benefit from other treatment to supplement a physical activity program.

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.

Interventions

BEHAVIORALPhysical 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.

BEHAVIORALCognitive Behavioral Therapy

Telephone-based training in multiple skills for managing low back pain.

Sponsors

Duke University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Self-report having had lower back pain on most days for greater than three months. 2. Can complete a 10 second semi-tandem stand and walk 8' in 6.0 seconds. 3. 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. 4. Can safely participate in the intervention based upon the physical therapist baseline examination and clinical expertise.

Exclusion criteria

1. 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); 2. dementia or other significant cognitive impairment; 3. movement or motor neuron disorders (e.g., Parkinson's Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis); 4. rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease; 5. hospitalization for a stroke, myocardial infarction, heart failure, or coronary artery revascularization in the past 3 months; 6. significant hearing impairment (must be able to talk on the telephone); 7. psychosis or current, uncontrolled substance abuse disorder; 8. any other health conditions determined by the study team to be contraindications to performing mild to moderate home exercises.

Design outcomes

Primary

MeasureTime frameDescription
Timed Get-Up-And GoChange from baseline to 12-week follow-upThis 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.
PROMIS Health Assessment QuestionnaireChange from baseline to 12-week follow-upSelf-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.

Secondary

MeasureTime frameDescription
Patient Specific Functional ScaleChange from baseline to 12-week follow-upThis 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).
Roland-Morris Disease Specific Disability QuestionnaireChange from baseline to 12-week follow-up24-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.
Satisfaction With Physical Function ScaleChange from baseline to 12-week follow-upThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Physical 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.
20
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. Physical 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. Cognitive Behavioral Therapy: Telephone-based training in multiple skills for managing low back pain.
20
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.
20
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyExcluded by Study Team001
Overall StudyWithdrawal by Subject144

Baseline characteristics

CharacteristicPhysical Activity OnlyPhysical Activity + Cognitive Behavioral TherapyWait List Control GroupTotal
Age, Continuous69.6 years
STANDARD_DEVIATION 3.5
69.5 years
STANDARD_DEVIATION 4
71.9 years
STANDARD_DEVIATION 6.5
70.3 years
STANDARD_DEVIATION 4.9
Education Level
At least some college
13 Participants10 Participants8 Participants31 Participants
Education Level
High school or technical school
7 Participants10 Participants12 Participants29 Participants
Employment Status
Disabled
7 Participants8 Participants6 Participants21 Participants
Employment Status
Other
13 Participants12 Participants14 Participants39 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants20 Participants20 Participants59 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Household Financial Status
Low income
4 Participants6 Participants6 Participants16 Participants
Household Financial Status
Other
16 Participants13 Participants13 Participants42 Participants
Marital Status
Married
9 Participants13 Participants16 Participants38 Participants
Marital Status
Other
11 Participants7 Participants4 Participants22 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
11 Participants11 Participants9 Participants31 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants9 Participants11 Participants28 Participants
Sex: Female, Male
Female
1 Participants2 Participants1 Participants4 Participants
Sex: Female, Male
Male
19 Participants18 Participants19 Participants56 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 200 / 20
other
Total, other adverse events
0 / 200 / 200 / 20
serious
Total, serious adverse events
1 / 200 / 201 / 20

Outcome results

Primary

PROMIS Health Assessment Questionnaire

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.

Time frame: Change from baseline to 12-week follow-up

Population: 18 participants are missing data from this questionnaire because they entered a response of don't know for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data.

ArmMeasureValue (MEAN)
Physical Activity OnlyPROMIS Health Assessment Questionnaire-2.90 units on a scale
Physical Activity + Cognitive Behavioral TherapyPROMIS Health Assessment Questionnaire-0.89 units on a scale
Wait List Control GroupPROMIS Health Assessment Questionnaire3.21 units on a scale
Comparison: This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.p-value: 0.0795% CI: [-12.85, 0.64]Mixed Models Analysis
Comparison: This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.p-value: 0.2895% CI: [-11.69, 3.48]Mixed Models Analysis
Primary

Timed Get-Up-And Go

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.

Time frame: Change from baseline to 12-week follow-up

Population: The analysis populations includes all participants except for one who was unable to stand without assistance and declined to perform this test at both baseline and follow-up.

ArmMeasureValue (MEAN)
Physical Activity OnlyTimed Get-Up-And Go-1.84 seconds
Physical Activity + Cognitive Behavioral TherapyTimed Get-Up-And Go-2.15 seconds
Wait List Control GroupTimed Get-Up-And Go1.11 seconds
Comparison: This is the comparison between physical activity only and the wait list group. Rejection of the null hypothesis means that the physical activity group had greater improvement than the wait list group.p-value: 0.0895% CI: [-6.24, 0.35]Mixed Models Analysis
Comparison: This is the comparison of the PA \& CBT group to the wait list group. Rejection of the null hypothesis means that the PA + CBT group was superior on this outcome to the wait list group.p-value: 0.0695% CI: [-6.69, 0.06]Mixed Models Analysis
Secondary

Patient Specific Functional Scale

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).

Time frame: Change from baseline to 12-week follow-up

ArmMeasureValue (MEAN)
Physical Activity OnlyPatient Specific Functional Scale3.72 units on a scale
Physical Activity + Cognitive Behavioral TherapyPatient Specific Functional Scale3.00 units on a scale
Wait List Control GroupPatient Specific Functional Scale0.08 units on a scale
Comparison: This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.p-value: 0.09795% CI: [-0.69, 7.96]Mixed Models Analysis
Comparison: This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.p-value: 0.19695% CI: [-1.55, 7.39]Mixed Models Analysis
Secondary

Roland-Morris Disease Specific Disability Questionnaire

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.

Time frame: Change from baseline to 12-week follow-up

ArmMeasureValue (MEAN)
Physical Activity OnlyRoland-Morris Disease Specific Disability Questionnaire-3.21 units on a scale
Physical Activity + Cognitive Behavioral TherapyRoland-Morris Disease Specific Disability Questionnaire-1.11 units on a scale
Wait List Control GroupRoland-Morris Disease Specific Disability Questionnaire0.89 units on a scale
Comparison: This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.p-value: <0.0195% CI: [-6.85, -1.34]Mixed Models Analysis
Comparison: This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.p-value: 0.1795% CI: [-4.85, 0.86]Mixed Models Analysis
Secondary

Satisfaction With Physical Function Scale

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.

Time frame: Change from baseline to 12-week follow-up

Population: 6 participants are missing data from this questionnaire because they entered a response of don't know for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data.

ArmMeasureValue (MEAN)
Physical Activity OnlySatisfaction With Physical Function Scale3.11 units on a scale
Physical Activity + Cognitive Behavioral TherapySatisfaction With Physical Function Scale3.06 units on a scale
Wait List Control GroupSatisfaction With Physical Function Scale2.96 units on a scale
Comparison: This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.p-value: 0.9595% CI: [-4.86, 5.19]Mixed Models Analysis
Comparison: This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.p-value: 0.9795% CI: [-7.07, 1.07]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026