Improving Rehabilitation Outcomes After Total Hip Arthroplasty

NCT02920866 | Completed Results

• 2 other identifiers: O2251-I16-0956
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty; Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test (6MW)

  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. Higher numbers indicate better function. 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).

  Change in 6MW from baseline to intervention end-point (after 8 week intervention; POST2)

Secondary Outcomes (12)

• 4 Meter Walk (4MW)

  Change in 4MW from baseline to intervention end-point (after 8 week intervention; POST2)

• 30 Second Sit-to-stand (30 STS)

  Change in 30 STS from baseline to intervention end-point (after 8 week intervention; POST2)

• Functional Gait Assessment (FGA)

  Change in FGA from baseline to intervention end-point (after 8 week intervention; POST2)

• Isometric Strength

  Change in strength from baseline to intervention end-point (after 8 week intervention; POST2)

• Modified Trendelenburg Test

  Change in Trendelenburg test from baseline to intervention end-point (after 8 week intervention; POST2)

Other Outcomes (3)

• Pain Levels at Rest and With Activity

  Quantification at baseline, POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)

• Injury

  POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)

• Falls

  Quantification at baseline, POST1 (after 4 weeks intervention), POST2 (after 8 weeks intervention), and POST3 (26 weeks after initiating rehabilitation)

Study Arms (2)

Functional Strength Integration (FSI)

EXPERIMENTAL

Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength

Behavioral: Functional Strength Integration (FSI)

Control Group (CON)

ACTIVE COMPARATOR

Usual care, continuing education on postsurgical precautions

Behavioral: Control Group (CON)

Interventions

Functional Strength Integration (FSI) BEHAVIORAL

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.

Functional Strength Integration (FSI)

Control Group (CON) BEHAVIORAL

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.

Control Group (CON)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

Related Publications (13)

• 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.

  PMID: 11773212 RESULT

• 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.

  PMID: 10914862 RESULT

• 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.

  PMID: 20222962 RESULT

• 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.

  PMID: 20191491 RESULT

• 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.

  PMID: 18927190 RESULT

• 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.

  PMID: 18375881 RESULT

• 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.

  PMID: 24170713 RESULT

• 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.

  PMID: 20886649 RESULT

• 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.

  PMID: 10831810 RESULT

• 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.

  PMID: 20565735 RESULT

• 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.

  PMID: 20888285 RESULT

• 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.

  PMID: 18296944 RESULT

• 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.

  PMID: 31392991 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Jennifer Stevens-Lapsley
• Organization: University of Colorado Denver

jennifer.stevens-lapsley@cuanschutz.edu

303.724.9170

Study Officials

• Jennifer E. Stevens-Lapsley, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 30, 2016
• Study Start: November 1, 2016
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: May 21, 2024
• Results First Posted: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)