Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

NCT03226106 | Completed Results

• 1 other identifier: F2417-R
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Osteoarthritis

Keywords

Rehabilitation; Total Knee Arthroplasty; Telemedicine; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Free-living Daily Step Count

  Accelerometer-based measurement of free-living daily step count

  End of intervention (14 weeks)

Secondary Outcomes (13)

• 30-Second Chair-Stand Test W14

  End of intervention (14 weeks)

• 30-Second Chair-Stand Test W38

  24 weeks after intervention (week 38 of study)

• Six-Minute Walk Test W14

  End of intervention (14 weeks)

• Six-Minute Walk Test W38

  24 weeks after intervention (week 38 of study)

• Timed Up-and-Go Test W14

  End of intervention (14 weeks)

Study Arms (2)

Physical Activity Behavior Intervention

EXPERIMENTAL

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.

Behavioral: Physical Activity Behavior Intervention

Attention Control

ACTIVE COMPARATOR

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.

Other: Attention Control

Interventions

Physical Activity Behavior Intervention 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.

Physical Activity Behavior Intervention

Attention Control 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.

Attention Control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• Planned unilateral total knee arthroplasty

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 30329126 BACKGROUND

• 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.

  PMID: 37819260 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Results Point of Contact

• Title: Cory Christiansen, PT, PhD
• Organization: Eastern Colorado VA Medical Center

cory.christiansen@cuanschutz.edu

303-724-9101

Study Officials

• Cory L. Christiansen, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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

Model Details: Randomized controlled trial; Two groups.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 21, 2017
• Study Start: November 15, 2017
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)