Arthroplasty, Replacement, HipFMR-THANCT01878175
Functional Movement Retraining After Hip Replacement
A study testing Functional Movement Retraining in people with Arthroplasty, Replacement, Hip, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often used to treat hip osteoarthritis, which is more common among Veterans than the general population. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Functional Movement Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Dec 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran, Scheduled for hip arthroplasty at Durham, NC VA Medical Center
Who cannot join
- Dementia or other significant cognitive impairment;
- movement or motor neuron disorders (e.g., Parkinson's Disease, post-stroke neurological deficiencies);
- rheumatoid arthritis,
- fibromyalgia,
- or other systemic rheumatic disease;
- hospitalization for a stroke,
Show all 12Show fewer
- myocardial infarction,
- heart failure,
- or coronary artery revascularization in the past 3 months;
- psychosis or current, uncontrolled substance abuse disorder;
- any other health conditions determined by the study team to be contraindications to performing the exercise program (e.g., mild home exercises);
- transportation or other limitations that would prevent visits to the Durham VAMC for the retraining program.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27705
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Functional Movement Retraining After Hip Arthroplasty in Veterans: Pilot Study
Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often used to treat hip osteoarthritis, which is more common among Veterans than the general population. Some patients continue to experience functional limitations after THA, and studies have shown that these patients still tend to put greater loads on the opposite leg, which can increase the risk of developing osteoarthritis in that leg. One likely reason for these post-surgical limitations is that rehabilitation is very minimal following this procedure. This project will involve development and preliminary testing of a functional movement retraining program, designed to help Veterans improve their function and biomechanics after THA. The project will also develop processes for delivering this program in Veterans' homes, to increase accessibility.
Read the detailed description
Rehabilitation following total hip arthroplasty (THA) is limited in scope, and some patients continue to exhibit functional limitations, as well as loading asymmetries that place them at risk for developing osteoarthritis in contralateral joints. The purpose of this study is to collect preliminary data to support a larger project that will examine the effectiveness of a 12-session functional movement retraining (FMR) program for Veterans following THA. A novel aspect of the FMR program is that it focuses not only on improving overall function but also normalizing side-to-side asymmetries in balance and strength via patient-specific tailoring of exercises. The program also involves telerehabilitation processes to improve access.
Participants will be n=15 patients scheduled for THA at the Durham VAMC, identified from electronic medical records. Participants will complete assessments pre-operatively, then approximately 6-weeks post-THA, at which time FMR program will begin. The 12 FMR sessions will optimally be delivered twice weekly for 6 weeks. However, to account for missed visits, the investigators will allow for 9 total weeks to complete the 12 sessions. Therefore follow-up assessments will be scheduled at 15-weeks post-THA for all participants. FMR sessions will be a combination of: 1.) in-person, on-site visits and telephone contacts with a licensed physical therapist and 2.) in-home telehealth visits by a telehealth technologist or physical therapy assistant. The FMR program will focus on improving lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform a series of stretching exercises daily and strengthening exercises three times weekly. Exercises for each patient will be tailored according to results of the Lower Quarter Y-Balance Test (conducted at baseline and mid-way through the program), which assesses asymmetries between limbs and between anterior vs. posterior reach. Outcomes will include objective functional measures (timed up-and-go, sit-to-stand, walking speed, stair climb, Lower Quarter Y-Balance Test), self-reported pain and activity limitations (Hip disability and Osteoarthritis Outcome Score), and therapist-assessed function (Harris Hip Score). Basic descriptive statistics will be used to compare changes in each outcome (pre-operative to 15-week post-THA and 6-week post THA to 15-week post-THA) and inform sample size estimates for a larger trial. The investigators will also assess various aspects of program feasibility (recruitment success, adherence, telerehabilitation processes) and collect in-depth qualitative information from both patients and therapists to assess aspects of the intervention that may need to be modified prior to a larger study.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Functional Movement Retraining
- Keywords
- Arthroplasty, Replacement, Hip, Veterans, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Movement RetrainingBehavioural
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
| Study group | Role | What they receive |
|---|---|---|
| Functional Movement Retraining | Experimental | 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days). Receives: Behavioral: Functional Movement Retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Secondary outcomes (9)
Change in Satisfaction With Physical Function Questionnaire
This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity osteoarthritis (OA), including stair-climbing, walking, doing housework (light and heavy), and lifting and carrying. The scale range is -15 to +15, with higher scores indicating more satisfaction with function. Change was defined as post-intervention minus pre-intervention. Therefore a positive change score indicates improvement over time.
Measured: Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)
Global Assessment of Hip Symptom Change
We will use the Patient Global Impression of Change scale to evaluate participants' perspectives on overall change in their joint pain in their (one) operative hip during the study period. This single-item measure asks participants to describe their change in pain on a rating scale with the following 13 options: a little worse, somewhat worse, moderately worse, a good deal worse, a great deal worse, a very great deal worse, about the same, a little better, somewhat better, moderately better, a good deal better, a great deal better, a very great deal better. The total scale range is -6 to +6. Negative scores indicate greater perceived improvement.
Measured: 15 weeks (post-intervention)
Change in Objective Functional Test: Timed Get Up-and-go
The timed get up-and-go test has demonstrated excellent reliability and correlates well with other standard measures such as gait speed, self-report and clinical report indices of function, and is predictive of who can safely ambulate. This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Participants are asked to complete this as quickly and safely as possible, without the use of an assistive device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective Functional Test: Sit to Stand
The Sit-to-Stand Test has been reported to be a good indicator of postural control, fall risk, lower-extremity strength, and disability. During the sit-to-stand test participants will be asked to place their arms across their chest and keep their feet flat on the floor. They will then be asked to stand up and sit down 5 times as fast as they can. This will be repeated twice and the scores will be averaged for analysis. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective Functional Test: Walking Speed
Gait speed is a global measure of disability and function and has been correlated with disease processes, fitness level, activities of daily living, and emotional states. In addition, gait speed is an imperative measure for integration to safe and effective community ambulatory status, and has been defined as a reflective measure of function. Walking speed will be determined as the average walking speed over a 3 meter walk. Participants will be asked to walk down a 10 meter walkway 7 times (while wearing standard footwear) to have their walking speed monitored using infrared photocells, while speed is monitored over the middle 3 meters. These seven trials will be averaged in order to determine walking speed at each of the three visits. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective Functional Test: Stair Climbing
The task of stair climbing has been found to be sensitive to change with interventions in individuals with knee OA. This measures the time it takes a participant to ascend and descend a flight of 12 steps (each step 18 cm high and 28 cm deep). Participants will be asked to complete the test as quickly as they felt safe and comfortable. The use of one handrail will be allowed if necessary, but patients will be encouraged to minimize their use of the handrail. One practice trial will be performed and the average of two additional tests will be used for analysis. The use of an assistive device will be allowed only if the subject will be unsafe or cannot complete the test without the use of the device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in University of California Los Angeles (UCLA) Activity Questionnaire
The UCLA scale shows a strong correlation with the other measures (r = -0.35 to 0.56 for THA; r = -0.55 to 0.23 for TKA) and discriminates between insufficiently and sufficiently active patients undergoing THA and TKA. The UCLA scale has good reliability, provides high completion rate, and shows no floor effects. It seems to be the most appropriate scale for assessment of physical activity levels in patients undergoing total joint arthroplasty. The UCLA scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as 'no physical activity, dependent on others' and 10 defined as 'regular participation in impact sports.' Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Harris Hip Score (HHS)
The HHS is the most widely used physician- or therapist-assessed measure of hip function following THA and associated rehabilitation. Although the HHS has also been used in a patient-report format, in this study we will obtain this measure via therapist report, to complement the patient-reported outcomes described above. This measure covers the domains of pain (severity and effects on activities and need for pain medication, function (daily activities and gait), deformity (hip flexion, adduction, internal rotation, and extremity length discrepancy) and range of motion (hip flexion, abduction, internal and external rotation, and adduction). The HHS includes 10 items, with a total score range of 0-100; higher scores indicating better function. The HHS has been shown to be a reliable and valid measure of hip function. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Lower Quarter Y-balance Test (YBT-LQ)
The YBT-LQ is a test of dynamic balance in unilateral stance . It will be administered to all patients who pass a clearance test, which consists of being able to stand on one leg for 10 seconds. The YBT-LQ is performed for both left and right limbs. Any trial that is failed will be repeated with a maximum of 4 additional trials to be performed in each reach direction, anterior, posterior, and lateral. NOTE: Only although 13 participants began the clearance test at both time points, only 5 participants were able to pass the clearance test required to do the YBT-LQ at 6 weeks. Therefore we have not provided a change score for YBT-LQ since this would involve a very small number of participants, and we are concerned about validity of the results that would be presented since those who completed the test at 6 weeks may be a biased sample. We therefore provide the difference (post minus pre) in the # of participants who completed the clearance test at 15 weeks (9) vs. 6 weeks (5).
Measured: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionDec 2016
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.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Kelli Dominick Allen, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878175
- Sponsor's protocol ID
- O1033-P
- Acronym
- FMR-THA
- Status last verified
- Jan 2017
- First submitted
- 5 Jun 2013
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Movement Retraining After Hip Arthroplasty in Veterans: Pilot Study
- ClinicalTrials.gov ID
- NCT01878175
- Acronym / sponsor ID
- FMR-THA / O1033-P
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Arthroplasty, Replacement, Hip, Veterans, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Duke University
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Posted 28 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often used to treat hip osteoarthritis, which is more common among Veterans than the general population. Some patients continue to experience functional limitations after THA, and studies have shown that these patients still tend to put greater loads on the opposite leg, which can increase the risk of developing osteoarthritis in that leg. One likely reason for these post-surgical limitations is that rehabilitation is very minimal following this procedure. This project will involve development and preliminary testing of a functional movement retraining program, designed to help Veterans improve their function and biomechanics after THA. The project will also develop processes for delivering this program in Veterans' homes, to increase accessibility.
Detailed description
Rehabilitation following total hip arthroplasty (THA) is limited in scope, and some patients continue to exhibit functional limitations, as well as loading asymmetries that place them at risk for developing osteoarthritis in contralateral joints. The purpose of this study is to collect preliminary data to support a larger project that will examine the effectiveness of a 12-session functional movement retraining (FMR) program for Veterans following THA. A novel aspect of the FMR program is that it focuses not only on improving overall function but also normalizing side-to-side asymmetries in balance and strength via patient-specific tailoring of exercises. The program also involves telerehabilitation processes to improve access.
Participants will be n=15 patients scheduled for THA at the Durham VAMC, identified from electronic medical records. Participants will complete assessments pre-operatively, then approximately 6-weeks post-THA, at which time FMR program will begin. The 12 FMR sessions will optimally be delivered twice weekly for 6 weeks. However, to account for missed visits, the investigators will allow for 9 total weeks to complete the 12 sessions. Therefore follow-up assessments will be scheduled at 15-weeks post-THA for all participants. FMR sessions will be a combination of: 1.) in-person, on-site visits and telephone contacts with a licensed physical therapist and 2.) in-home telehealth visits by a telehealth technologist or physical therapy assistant. The FMR program will focus on improving lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform a series of stretching exercises daily and strengthening exercises three times weekly. Exercises for each patient will be tailored according to results of the Lower Quarter Y-Balance Test (conducted at baseline and mid-way through the program), which assesses asymmetries between limbs and between anterior vs. posterior reach. Outcomes will include objective functional measures (timed up-and-go, sit-to-stand, walking speed, stair climb, Lower Quarter Y-Balance Test), self-reported pain and activity limitations (Hip disability and Osteoarthritis Outcome Score), and therapist-assessed function (Harris Hip Score). Basic descriptive statistics will be used to compare changes in each outcome (pre-operative to 15-week post-THA and 6-week post THA to 15-week post-THA) and inform sample size estimates for a larger trial. The investigators will also assess various aspects of program feasibility (recruitment success, adherence, telerehabilitation processes) and collect in-depth qualitative information from both patients and therapists to assess aspects of the intervention that may need to be modified prior to a larger study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Movement Retraining | Experimental | Behavioral: Functional Movement Retraining15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veteran, Scheduled for hip arthroplasty at Durham, NC VA Medical Center
Key exclusion criteria (12 listed)
- Dementia or other significant cognitive impairment;
- movement or motor neuron disorders (e.g., Parkinson's Disease, post-stroke neurological deficiencies);
- rheumatoid arthritis,
- fibromyalgia,
- or other systemic rheumatic disease;
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 Movement Retraining15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days). | Behavioural | Functional Movement Retraining |
Primary outcome
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.
9 secondary outcomes
Change in Satisfaction With Physical Function Questionnaire
Time frame: Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)
Global Assessment of Hip Symptom Change
Time frame: 15 weeks (post-intervention)
Change in Objective Functional Test: Timed Get Up-and-go
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective Functional Test: Sit to Stand
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective Functional Test: Walking Speed
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Objective Functional Test: Stair Climbing
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in University of California Los Angeles (UCLA) Activity Questionnaire
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Harris Hip Score (HHS)
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Change in Lower Quarter Y-balance Test (YBT-LQ)
Time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelli Dominick Allen, PhD principal investigator
Durham VA Medical Center, Durham, NC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Movement Retraining in people with Arthroplasty, Replacement, Hip, run by VA Office of Research and Development at 2 sites 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 1 inclusion and 12 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 28 Feb 2017). 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?
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale (time frame: Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2017.