Improving Rehabilitation Outcomes After Total Hip Arthroplasty

• ClinicalTrials.gov Identifier: NCT02920866
• Recruitment Status: Recruiting
• First Posted: September 30, 2016
• Last Update Posted: November 2, 2020
• Sponsor: VA Office of Research and Development
• Collaborator: University of Colorado, Denver
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

This study plans to learn more about the effects of physical therapy (PT) following a total hip arthroplasty (THA). The purpose of this study is to compare standard of care PT after THA with a physical therapy program specifically designed to integrate targeted core and hip muscle strength and functional training.

Condition or disease	Intervention/treatment	Phase
Total Hip Arthroplasty; Osteoarthritis	Behavioral: Functional Strength Integration (FSI); Behavioral: Control Group (CON)	Not Applicable

Detailed Description:

Over the next 20 years, the number of total hip arthroplasties (THAs) performed to alleviate pain and disability associated with osteoarthritis (OA) is expected to double to more than 500,000/year. Most patients report improved health-related quality of life following surgery; however, deficits in physical function and quality of life persist. Specifically, Veterans with THA have a higher prevalence of severe activities of daily living (ADL) limitations and report severe physical health-related quality of life deficits. The increased THA utilization, combined with long-term functional deficits which increase heath care utilization, suggests a need for targeted rehabilitation strategies to improve physical function for Veterans after THA.

Movement compensations are a biomarker of functional decline in a variety of older adult populations. For patients with THA, persistent movement compensations are seen in activities of daily living, such as level walking, sit-to-stand transitions, and stair climbing. These movement compensations likely stem from a combination of poor muscle strength and a failure to integrate available muscle strength into functional movement. Functional strength integration (FSI) during daily tasks refers to the ability of the body to produce stable, coordinated movements. At the hip joint, optimal FSI is largely dependent on the ability of hip abductor muscles to produce sufficient hip abduction moments to stabilize the pelvis during unilateral stance tasks. Thus, inability to integrate hip abductor muscle strength during functional tasks results in poor pelvic stability and movement compensations. Lack of FSI possibly explains the deficits in functional recovery after THA. However, current rehabilitation practices do not target the integration of strength and functional movement to resolve movement compensations.

Rehabilitation emphasizing functional strength integration after THA has the potential to substantially improve postoperative physical function by remediating movement compensations with greater hip abductor strength and recruitment during function, providing greater pelvic control and better movement quality. Therefore, the investigators propose a randomized controlled trial of 100 participants to determine if an 8-week functional strength integration (FSI) program after THA improves physical function and muscle performance more than control intervention (CON) after unilateral THA. The secondary goal is to determine if FSI improves movement compensations during functional activity (walking and stair climbing). Eight weeks of intervention will be initiated 2 weeks after THA to allow for early tissue healing. Outcomes will be assessed pre-operatively (PRE); intervention mid-point (after 4 weeks intervention; POST1); intervention end-point (after 8 weeks intervention; POST2) (primary endpoint); and late recovery (26 weeks after initiating rehabilitation; POST3).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Rehabilitation Outcomes After Total Hip Arthroplasty
• Actual Study Start Date: November 1, 2016
• Estimated Primary Completion Date: February 28, 2021
• Estimated Study Completion Date: October 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Functional Strength Integration (FSI); Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength	Behavioral: Functional Strength Integration (FSI); FSI intervention involves strengthening of the hip musculature combined with focused techniques emphasizing early initiation of hip muscle recruitment to stabilize the pelvis, integrating strength and movement pattern training to maximize functional recovery. The FSI program consists of therapeutic exercise in 3 domains: pelvic stability (PST) training, functional training (FT), and strength training (ST). PST includes early surgical-limb weight bearing and core muscle strengthening, progressively increasing in difficulty based on performance benchmarks and therapist monitoring. FT focuses on gait and stair climb exercise, progressing to higher level agility training. ST includes progressive, resistance exercise to improve lower extremity muscle strength. The ST exercises include use of weighted pulleys/weight-training machines. Therapists will determine an 8-rep max for muscle groups and weight will be increased by 10% every 2 weeks to maximize hypertrophy and strength gains.
Active Comparator: Control Group (CON); Usual care, continuing education on postsurgical precautions	Behavioral: Control Group (CON); Observed practice patterns from previous investigations and discussion with physical therapists indicate that patients receive rehabilitation services during the 2-3 day hospital stay after THA, but not routinely after hospital discharge. Yet, to control for attention and volume of rehabilitation for the FSI group, patients in the control group will attend outpatient physical therapy for 14 visits (40 minute sessions) over 8 weeks. This control program will mimic the typical postoperative experience for patients in our community, in which patients independently manage their activity. This program will focus on patient education, functional ADL training, and therapeutic exercise. However, the activities in the exercise domain will be limited to low load exercise such as isometric muscle exercise, range of motion (ROM), and flexibility activities. These activities are specifically designed to mirror usual care activity.

Outcome Measures

Primary Outcome Measures :

1. 6 minute walk test (6MW) [ Time Frame: Change in 6MW from baseline to intervention end-point (after 8 week intervention; POST2) ]
   Patients will perform a 6MW test, which assesses how far a patient walks in 6 minutes. The 6MW test was chosen as the primary outcome because it captures performance over a period of time that best mimics community ambulation with activities of daily living. The 6MW test is reliable and valid in the post-THA population and can detect small changes in function after THA. 6MW will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).

Secondary Outcome Measures :

1. 4 meter walk (4MW) [ Time Frame: Change in 4MW from baseline to intervention end-point (after 8 week intervention; POST2) ]
   The 4MW test measures the time to walk 4 meters and has been used to generate gait speed values, which have been associated with morbidity and mortality in older adults. Participants will perform the 4MW with instructions to walk in their "normal, everyday pace." 4MW will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
2. 30 second sit-to-stand (30 STS) [ Time Frame: Change in 30 STS from baseline to intervention end-point (after 8 week intervention; POST2) ]
   The 30 second sit-to-stand test assesses functional lower extremity strength and endurance, and has been validated and found reliable in older adults at various physical activity levels and physical independence levels. 30 STS will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
3. Functional Gait Assessment (FGA) [ Time Frame: Change in FGA from baseline to intervention end-point (after 8 week intervention; POST2) ]
   Participants will also perform the FGA, which is a 10-item objective outcome measure designed to measure dynamic balance while walking in the presence of external demands, and will provide information on patients' stability before and after THA. The FGA has been shown to be a reliable and valid measure, effective in classifying fall risk in older adults and predicting unexplained falls. FGA will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
4. Isometric strength [ Time Frame: Change in strength from baseline to intervention end-point (after 8 week intervention; POST2) ]
   Isometric strength of the quadriceps and hip abductor muscles will be assessed on a handheld dynamometer. All strength testing will be performed in positions that minimize the risk of hip dislocation post-operatively, while still allowing for optimal trunk and pelvic stabilization. Isometric quadriceps strength testing will be performed in sitting at 0 hip flexion and 60 knee flexion. Isometric hip abduction strength testing will be performed in side lying at 0 flexion/extension and 0 hip abduction. Testing will include warm-up repetitions, followed by three separate maximal voluntary isometric contractions while receiving visual and verbal feedback. Strength will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
5. Modified Trendelenburg test [ Time Frame: Change in Trendelenburg test from baseline to intervention end-point (after 8 week intervention; POST2) ]
   Patients will complete hip abductor endurance testing using a static single-limb balance test,. This modified Trendelenburg test assesses neuromuscular control during timed, single limb stance and indicates the ability of the lateral hip muscles to maintain pelvic control during closed-chain, functional tasks and therefore serves as a measure of hip abductor muscle endurance. This test will be performed using a high-speed motion-capture system to assess lateral pelvic tilt. Differences will be analyzed in pelvic tilt angles from preoperative to postoperative assessments during the single-limb task on the surgical leg. Trendelenburg will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
6. Peak internal hip abduction moment [ Time Frame: Change in moment from baseline to intervention end-point (after 8 week intervention; POST2) ]
   Surgical limb peak internal hip abduction moment will be calculated with 3-D instrumented motion analysis. Continuous internal hip abduction moments will be calculated during functional task performance using a standard inverse dynamics approach integrating kinematic and kinetic data using Visual 3D software (C-Motion, Germantown, MD). From the continuous hip moments, peak surgical limb internal hip abduction moments during the Loading Response phase of the stance period of the walking trials will be collected. Moments will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
7. ActiGraph [ Time Frame: Change in physical activity from baseline to intervention end-point (after 8 week intervention; POST2) ]
   ActiGraph activity monitors assess physical activity (PA) using accelerometry, which allows objective evaluation of the relative volume (steps/day) and intensity (activity counts) of physical activity with high validity and reliability. Each participant will wear the ActiGraph for at least 4 days at all time points to assess average daily PA (steps/day). PA will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
8. Veterans RAND 12-item health survey (VR-12) [ Time Frame: Change in VR-12 from baseline to intervention end-point (after 8 week intervention; POST2) ]
   The VR-12 is a reliable, self-report survey for assessing health-related quality of life. VR-12 scores will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
9. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change in WOMAC from baseline to intervention end-point (after 8 week intervention; POST2) ]
   The WOMAC is a self-report questionnaire that assesses the impact of osteoarthritis on pain, stiffness, and disability. The WOMAC has been shown to be a valid, reliable, and responsive instrument often used in clinical trials. WOMAC scores will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
10. Patient Activation Measure (PAM) [ Time Frame: Assessed at baseline only ]
    The PAM survey assesses patient knowledge, skill, and confidence for self-management, as self-efficacy exhibits a positive relationship with preventive actions and health outcomes.
11. Motivation scale [ Time Frame: Quantification at POST1 (after 4 weeks intervention) & POST 2 (after 8 weeks intervention) ]
    The motivation scales asks the participant "How motivated do you feel to participate in physical therapy?", and rating on a 0 (not at all motivated) to 10 (very motivated) scale.

Other Outcome Measures:

1. Falls, injury, pain [ Time Frame: Quantification at baseline, POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation) ]
   Patients will report falls, musculoskeletal injury history, and pain levels at rest and with activity (numerical pain rating scale [NPRS; 0= no pain, 10= worst possible pain]) at all testing timepoints.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• BMI less than or equal to 40
• Receiving unilateral primary total hip arthroplasty for osteoarthritis

Exclusion Criteria:

• Severe contralateral leg OA (>= 5/10 pain with stair climbing)
• Other unstable orthopaedic conditions that limit function
• Neurological or pulmonary problems that severely limit function
• Uncontrolled hypertension or diabetes
• Use of illegal substances

Contacts and Locations

Contacts

Contact: Jennifer E Stevens-Lapsley, PhD; (303) 949-9304; Jennifer.Stevens-Lapsley@va.gov

Locations

United States, Colorado

Rocky Mountain Regional VA Medical Center, Aurora, CO; Recruiting

Aurora, Colorado, United States, 80045

Contact: Jennifer E Stevens-Lapsley, PhD 303-949-9304 Jennifer.Stevens-Lapsley@va.gov

Principal Investigator: Jennifer E. Stevens-Lapsley, PhD

Sponsors and Collaborators

VA Office of Research and Development

University of Colorado, Denver

Investigators

• Principal Investigator: Jennifer E. Stevens-Lapsley, PhD; Rocky Mountain Regional VA Medical Center, Aurora, CO

More Information

Publications of Results:

Sicard-Rosenbaum L, Light KE, Behrman AL. Gait, lower extremity strength, and self-assessed mobility after hip arthroplasty. J Gerontol A Biol Sci Med Sci. 2002 Jan;57(1):M47-51.

Jones CA, Voaklander DC, Johnston DW, Suarez-Almazor ME. Health related quality of life outcomes after total hip and knee arthroplasties in a community based population. J Rheumatol. 2000 Jul;27(7):1745-52.

Nilsdotter AK, Isaksson F. Patient relevant outcome 7 years after total hip replacement for OA - a prospective study. BMC Musculoskelet Disord. 2010 Mar 11;11:47. doi: 10.1186/1471-2474-11-47.

Rat AC, Guillemin F, Osnowycz G, Delagoutte JP, Cuny C, Mainard D, Baumann C. Total hip or knee replacement for osteoarthritis: mid- and long-term quality of life. Arthritis Care Res (Hoboken). 2010 Jan 15;62(1):54-62. doi: 10.1002/acr.20014.

Singh JA, Sloan JA. Health-related quality of life in veterans with prevalent total knee arthroplasty and total hip arthroplasty. Rheumatology (Oxford). 2008 Dec;47(12):1826-31. doi: 10.1093/rheumatology/ken381. Epub 2008 Oct 16.

Clough-Gorr KM, Erpen T, Gillmann G, von Renteln-Kruse W, Iliffe S, Beck JC, Stuck AE. Preclinical disability as a risk factor for falls in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2008 Mar;63(3):314-20.

Higgins TJ, Janelle CM, Manini TM. Diving below the surface of progressive disability: considering compensatory strategies as evidence of sub-clinical disability. J Gerontol B Psychol Sci Soc Sci. 2014 Mar;69(2):263-74. doi: 10.1093/geronb/gbt110. Epub 2013 Oct 29. Review.

Lamontagne M, Beaulieu ML, Beaulé PE. Comparison of joint mechanics of both lower limbs of THA patients with healthy participants during stair ascent and descent. J Orthop Res. 2011 Mar;29(3):305-11. doi: 10.1002/jor.21248. Epub 2010 Sep 30. Erratum in: J Orthop Res. 2011 Sep;29(9):1457.

Perron M, Malouin F, Moffet H, McFadyen BJ. Three-dimensional gait analysis in women with a total hip arthroplasty. Clin Biomech (Bristol, Avon). 2000 Aug;15(7):504-15.

Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126.

Grimaldi A. Assessing lateral stability of the hip and pelvis. Man Ther. 2011 Feb;16(1):26-32. doi: 10.1016/j.math.2010.08.005.

Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Judd DL, Cheuy VA, Forster JE, Christiansen CL, Stevens-Lapsley JE. Incorporating Specific Functional Strength Integration Techniques to Improve Functional Performance for Veterans After Total Hip Arthroplasty: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Nov 25;99(11):1453-1460. doi: 10.1093/ptj/pzz109.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02920866
• Other Study ID Numbers: O2251-I; 16-0956 ( Other Identifier: COMIRB )
• First Posted: September 30, 2016
• Last Update Posted: November 2, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Functional strength integration; Rehabilitation; Hip arthroplasty; Physical function; Muscle performance; Movement compensations

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases