Improving Rehabilitation Outcomes After Total Hip Arthroplasty
NCT ID: NCT02920866
Last Updated: 2024-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2016-11-01
2022-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Functional Strength Integration (FSI)
Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength
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.
Control Group (CON)
Usual care, continuing education on postsurgical precautions
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Receiving unilateral primary total hip arthroplasty for osteoarthritis
Exclusion Criteria
* Other unstable orthopaedic conditions that limit function
* Neurological or pulmonary problems that severely limit function
* Uncontrolled hypertension or diabetes
* Use of illegal substances
50 Years
85 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Jennifer E. Stevens-Lapsley, PhD
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain Regional VA Medical Center, Aurora, CO
Locations
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Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
Countries
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References
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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.
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. doi: 10.1093/gerona/63.3.314.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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16-0956
Identifier Type: OTHER
Identifier Source: secondary_id
O2251-I
Identifier Type: -
Identifier Source: org_study_id
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