Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

NCT ID: NCT03226106

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2023-05-15

Brief Summary

Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.

Detailed Description

This randomized clinical trial will assess the efficacy of using physical activity behavior change intervention for Veterans recovering from total knee arthroplasty. Testing will occur at baseline (before surgery), at intervention midpoint (8 weeks after surgery), end of intervention (14 weeks after surgery), and 24 weeks after intervention. The primary outcome is accelerometer-assessed daily step count. Secondary outcomes include the percent time engaged in standing and walking activity and physical function (Six-Minute Walk, 30-Second Chair-Stand Test, Timed Up-and-Go, Western Ontario and McMaster Universities Osteoarthritis Index, and the Veterans RAND 12-Item Health Survey.

Conditions

Total Knee Arthroplasty; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Activity Behavior Intervention

A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement.

Group Type: EXPERIMENTAL

Physical Activity Behavior Intervention

Intervention Type: BEHAVIORAL

Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Attention Control

Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: OTHER

Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.

Interventions

Physical Activity Behavior Intervention

Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Intervention Type: BEHAVIORAL

Attention Control

Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Veteran
• Planned unilateral total knee arthroplasty

Exclusion Criteria

• Severe non-surgical limb pain (pain >5/10 on non-surgical limb with walking)
• Unstable orthopedic, neurologic, or pulmonary condition that limits function
• Unstable cardiac condition
• Uncontrolled hypertension
• Uncontrolled diabetes
• Acute systemic infection
• Active cancer treatment
• Recent stroke (within 2 years)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cory L. Christiansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Countries

United States

References

Kline PW, Melanson EL, Sullivan WJ, Blatchford PJ, Miller MJ, Stevens-Lapsley JE, Christiansen CL. Improving Physical Activity Through Adjunct Telerehabilitation Following Total Knee Arthroplasty: Randomized Controlled Trial Protocol. Phys Ther. 2019 Jan 1;99(1):37-45. doi: 10.1093/ptj/pzy119.

Reference Type: BACKGROUND

PMID: 30329126 (View on PubMed)

Hoffman RM, Davis-Wilson HC, Hanlon S, Swink LA, Kline PW, Juarez-Colunga E, Melanson EL, Christiansen CL. Maximal daily stepping cadence partially explains functional capacity of individuals with end-stage knee osteoarthritis. PM R. 2024 Jun;16(6):532-542. doi: 10.1002/pmrj.13082. Epub 2023 Nov 27.

Reference Type: BACKGROUND

PMID: 37819260 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

F2417-R

Identifier Type: -

Identifier Source: org_study_id