Physical Activity for Older Adults Chronic Low Back Pain

NCT02327325 | Completed Results

• 1 other identifier: E1569-P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Exercise; Cognitive Behavioral Therapy; Aged

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline to 12-week follow-up

• 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.

  Change from baseline to 12-week follow-up

Secondary Outcomes (3)

• Patient Specific Functional Scale

  Change from baseline to 12-week follow-up

• Roland-Morris Disease Specific Disability Questionnaire

  Change from baseline to 12-week follow-up

• Satisfaction With Physical Function Scale

  Change from baseline to 12-week follow-up

Study Arms (3)

Physical Activity Only

EXPERIMENTAL

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.

Behavioral: Physical Activity

Physical Activity + Cognitive Behavioral Therapy

EXPERIMENTAL

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.

Behavioral: Physical Activity; Behavioral: Cognitive Behavioral Therapy

Wait List Control Group

NO INTERVENTION

Will receive the physical activity only or physical activity + cognitive behavioral therapy (based on participant choice) after completing all follow-up assessments.

Interventions

Physical Activity BEHAVIORAL

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 + Cognitive Behavioral Therapy; Physical Activity Only

Cognitive Behavioral Therapy BEHAVIORAL

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

Physical Activity + Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Duke University: collaborator

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Goode AP, Taylor SS, Hastings SN, Stanwyck C, Coffman CJ, Allen KD. Effects of a Home-Based Telephone-Supported Physical Activity Program for Older Adult Veterans With Chronic Low Back Pain. Phys Ther. 2018 May 1;98(5):369-380. doi: 10.1093/ptj/pzy026.

  PMID: 29669086 RESULT

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Kelli Allen, PhD
• Organization: Health Services Research & Development, Durham VA Healthcare System

kelli.allen@va.gov

919-286-0411

Study Officials

• Kelli Dominick Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 30, 2014
• Study Start: May 21, 2015
• Primary Completion: November 30, 2016
• Study Completion: March 1, 2017
• Last Updated: September 6, 2018
• Results First Posted: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)