Clinical trial NCT02920866: Improving Rehabilitation Outcomes After Total Hip Arthroplasty
Official title: Improving Rehabilitation Outcomes After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Osteoarthritis
Keywords: Functional strength integration
Rehabilitation
Hip arthroplasty
Physical function
Muscle performance
Movement compensations
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Colorado, Denver
First posted: 2016-09-30
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: 6 Minute Walk Test (6MW)
timeFrame: Change in 6MW from baseline to intervention end-point (after 8 week intervention; POST2)
Secondary outcomes:
measure: 4 Meter Walk (4MW)
timeFrame: Change in 4MW from baseline to intervention end-point (after 8 week intervention; POST2)
measure: 30 Second Sit-to-stand (30 STS)
timeFrame: Change in 30 STS from baseline to intervention end-point (after 8 week intervention; POST2)
measure: Functional Gait Assessment (FGA)
timeFrame: Change in FGA from baseline to intervention end-point (after 8 week intervention; POST2)
measure: Isometric Strength
timeFrame: Change in strength from baseline to intervention end-point (after 8 week intervention; POST2)
measure: Modified Trendelenburg Test
timeFrame: Change in Trendelenburg test from baseline to intervention end-point (after 8 week intervention; POST2)
measure: Peak Internal Hip Abduction Moment
timeFrame: Change in moment from baseline to intervention end-point (after 8 week intervention; POST2)
measure: ActiGraph
timeFrame: Change in physical activity from baseline to intervention end-point (after 8 week intervention; POST2)
measure: Veterans RAND 12-item Health Survey (VR-12)
timeFrame: Change in VR-12 from baseline to intervention end-point (after 8 week intervention; POST2)
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change in WOMAC from baseline to intervention end-point (after 8 week intervention; POST2)
measure: Patient Activation Measure (PAM)
timeFrame: Assessed at baseline only
measure: Patient Activation Measure (PAM) Categorical
timeFrame: Assessed at baseline only
measure: Motivation Scale
timeFrame: Quantification at Baseline
Other outcomes:
measure: Pain Levels at Rest and With Activity
timeFrame: Quantification at baseline, POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)
measure: Injury
timeFrame: POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)
measure: Falls
timeFrame: Quantification at baseline, POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Jennifer E. Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/gerona/57.1.m47.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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. doi: 10.1093/gerona/63.3.314.
citation: 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.
citation: Lamontagne M, Beaulieu ML, Beaule 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.
citation: Perron M, Malouin F, Moffet H, McFadyen BJ. Three-dimensional gait analysis in women with a total hip arthroplasty. Clin Biomech (Bristol). 2000 Aug;15(7):504-15. doi: 10.1016/s0268-0033(00)00002-4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.