Total Hip ArthroplastyNCT02920866
Improving Rehabilitation Outcomes After Total Hip Arthroplasty
A study testing Functional Strength Integration (FSI) in people with Total Hip Arthroplasty and Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Hip Arthroplasty, Osteoarthritis
- What is being tested?
- Functional Strength Integration (FSI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI less than or equal to 40
- Receiving unilateral primary total hip arthroplasty for osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
About this study
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.
Read the 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).
- Conditions
- Total Hip Arthroplasty, Osteoarthritis
- Being tested
- Functional Strength Integration (FSI), Control Group (CON)
- Keywords
- Functional strength integration, Rehabilitation, Hip arthroplasty, Physical function, Muscle performance, Movement compensations
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Strength Integration (FSI)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional Strength Integration (FSI) | Experimental | Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength Receives: Behavioral: Functional Strength Integration (FSI) |
| Control Group (CON) | Active comparator | Usual care, continuing education on postsurgical precautions Receives: Behavioral: Control Group (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change in 6MW from baseline to intervention end-point (after 8 week intervention; POST2)
Secondary outcomes (12)
4 Meter Walk (4MW)
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. Higher numbers indicate better speed values. 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).
Measured: Change in 4MW from baseline to intervention end-point (after 8 week intervention; POST2)
30 Second Sit-to-stand (30 STS)
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. Higher numbers indicate better lower extremity strength and endurance. 30 STS will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Measured: Change in 30 STS from baseline to intervention end-point (after 8 week intervention; POST2)
Functional Gait Assessment (FGA)
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. Scores range from 0-30, with higher scores indicating better functions. FGA will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Measured: Change in FGA from baseline to intervention end-point (after 8 week intervention; POST2)
Isometric Strength
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).
Measured: Change in strength from baseline to intervention end-point (after 8 week intervention; POST2)
Modified Trendelenburg Test
Patients will complete hip abductor endurance testing using a static single-limb balance test,. This modified Trendelenburg test assesses neuromuscular control during 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 in length of time pelvic control is maintained will be analyzed 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).
Measured: Change in Trendelenburg test from baseline to intervention end-point (after 8 week intervention; POST2)
Peak Internal Hip Abduction Moment
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). Peak internal hip moment during activity is a measurement of muscle activity during the task and provides insight to how muscles are activated during the task. Since the intervention exercise program targeted improving recruitment of the hip abductor moments during gait and other functional tasks, we calculated internal hip abduction moments. 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).
Measured: Change in moment from baseline to intervention end-point (after 8 week intervention; POST2)
ActiGraph
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). Higher number of steps indicates higher level of physical activity. PA will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Measured: Change in physical activity from baseline to intervention end-point (after 8 week intervention; POST2)
Veterans RAND 12-item Health Survey (VR-12)
The Veterans RAND (VR-12) is a reliable, self-report survey for assessing health-related quality of life. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome. VR-12 scores will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Measured: Change in VR-12 from baseline to intervention end-point (after 8 week intervention; POST2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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. Scores range from 0-96, with higher scores indicating more pain, stiffness, and disability. WOMAC scores will also be assessed at mid-intervention (POST1, 4 weeks) and 26-week evaluation (POST3).
Measured: Change in WOMAC from baseline to intervention end-point (after 8 week intervention; POST2)
Patient Activation Measure (PAM)
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. The Continuous Score is a composite score of the available 10 items, ranging from 0-100, wherein a higher score indicates a higher activation (better outcomes). The PAM Level is the mean of the 4 Categorical Levels, wherein a higher score indicates a higher activation (better outcomes). Categorical Level 1: disengaged and overwhelmed; Categorical Level 2: becoming aware but still struggling; Categorical Level 3: taking action \& gaining control; Categorical Level 4: maintaining behaviors \& pushing further. Specific cut offs for each Categorical Level are unavailable, as scoring is proprietary.
Measured: Assessed at baseline only
Patient Activation Measure (PAM) Categorical
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. The Categorical Levels are frequency distribution of the scores between 1-100, wherein a higher Categorical Level indicates a higher activation (better outcomes). Categorical Level 2: becoming aware but still struggling; Categorical Level 3: taking action \& gaining control; Categorical Level 4: maintaining behaviors \& pushing further. Specific cut offs for each Categorical Level are unavailable, as the scoring is proprietary.
Measured: Assessed at baseline only
Motivation Scale
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. Higher scores indicate higher level of motivation.
Measured: Quantification at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start1 Nov 2016
- Primary completion30 Sep 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Jennifer E. Stevens-Lapsley, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920866
- Sponsor's protocol ID
- O2251-I
- Other IDs
- 16-0956
- Status last verified
- Apr 2024
- First submitted
- 27 Sep 2016
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11773212Jones 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.
PubMed 10914862Nilsdotter 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.
PubMed 20222962Rat 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.
PubMed 20191491Singh 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.
PubMed 18927190Clough-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.
PubMed 18375881Higgins 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.
PubMed 24170713Lamontagne 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.
PubMed 20886649Perron 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.
PubMed 10831810Ageberg 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.
PubMed 20565735Grimaldi 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.
PubMed 20888285Akuthota 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.
PubMed 18296944Judd 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.
PubMed 31392991
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Rehabilitation Outcomes After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02920866
- Acronym / sponsor ID
- O2251-I
- Conditions
- Total Hip Arthroplasty, Osteoarthritis
- Keywords
- Functional strength integration, Rehabilitation, Hip arthroplasty, Physical function, Muscle performance, Movement compensations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Strength Integration (FSI) | Experimental | Behavioral: Functional Strength Integration (FSI)Progressive strength training exercise, specific functional activity to improve pelvic stability and core muscle strength |
| Control Group (CON) | Active comparator | Behavioral: Control Group (CON)Usual care, continuing education on postsurgical precautions |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI less than or equal to 40
- Receiving unilateral primary total hip arthroplasty for osteoarthritis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Functional Strength Integration (FSI) |
| 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. | Behavioural | Control Group (CON) |
Primary outcome
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. 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).
12 secondary outcomes
4 Meter Walk (4MW)
Time frame: Change in 4MW from baseline to intervention end-point (after 8 week intervention; POST2)
30 Second Sit-to-stand (30 STS)
Time frame: Change in 30 STS from baseline to intervention end-point (after 8 week intervention; POST2)
Functional Gait Assessment (FGA)
Time frame: Change in FGA from baseline to intervention end-point (after 8 week intervention; POST2)
Isometric Strength
Time frame: Change in strength from baseline to intervention end-point (after 8 week intervention; POST2)
Modified Trendelenburg Test
Time frame: Change in Trendelenburg test from baseline to intervention end-point (after 8 week intervention; POST2)
Peak Internal Hip Abduction Moment
Time frame: Change in moment from baseline to intervention end-point (after 8 week intervention; POST2)
ActiGraph
Time frame: Change in physical activity from baseline to intervention end-point (after 8 week intervention; POST2)
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)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change in WOMAC from baseline to intervention end-point (after 8 week intervention; POST2)
Patient Activation Measure (PAM)
Time frame: Assessed at baseline only
Patient Activation Measure (PAM) Categorical
Time frame: Assessed at baseline only
Motivation Scale
Time frame: Quantification at Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 11773212Sicard-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.
- Results publication: PubMed 10914862Jones 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.
- Results publication: PubMed 20222962Nilsdotter 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.
- Results publication: PubMed 20191491Rat 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.
- Results publication: PubMed 18927190Singh 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.
- Results publication: PubMed 18375881Clough-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.
- Results publication: PubMed 24170713Higgins 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.
- Results publication: PubMed 20886649Lamontagne 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.
- Results publication: PubMed 10831810Perron 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.
- Results publication: PubMed 20565735Ageberg 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.
- Results publication: PubMed 20888285Grimaldi 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.
- Results publication: PubMed 18296944Akuthota 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E. Stevens-Lapsley, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Strength Integration (FSI) in people with Total Hip Arthroplasty and Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (6MW) (time frame: Change in 6MW from baseline to intervention end-point (after 8 week intervention; POST2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920866, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.