NCT02920866

Improving Rehabilitation Outcomes After Total Hip Arthroplasty

Completed NA Results posted Last updated 21 May 2024

What this trial tests

NA trial testing Functional Strength Integration (FSI) in Total Hip Arthroplasty in 95 participants. Completed in 31 March 2022.

Timeline

1 November 2016

Primary endpoint
30 September 2021

31 March 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	95
Start date	1 November 2016
Primary completion	30 September 2021
Estimated completion	31 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Functional Strength Integration (FSI)
• Control Group (CON)

Conditions studied

• Total Hip Arthroplasty — all drugs for Total Hip Arthroplasty →
• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 50 to 85, any sex, with Total Hip Arthroplasty or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

6 Minute Walk Test (6MW) Primary · 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).

Group	Value	95% CI
Functional Strength Integration (FSI)	252.4	194.2 – 310.5
Control Group (CON)	207.0	151.5 – 262.5

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

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).

Group	Value	95% CI
Functional Strength Integration (FSI)	-0.69	-0.83 – -0.56
Control Group (CON)	-0.54	-0.67 – -0.41

30 Second Sit-to-stand (30 STS) Secondary · Change in 30 STS from baseline to intervention end-point (after 8 week intervention; POST2)

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).

Group	Value	95% CI
Functional Strength Integration (FSI)	4.22	3.07 – 5.36
Control Group (CON)	3.39	2.30 – 4.47

Functional Gait Assessment (FGA) Secondary · Change in FGA from baseline to intervention end-point (after 8 week intervention; POST2)

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).

Group	Value	95% CI
Functional Strength Integration (FSI)	3.71	2.66 – 4.76
Control Group (CON)	3.63	2.65 – 4.61

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

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 isometri

Involved Hip Abductor

Group	Value	95% CI
Functional Strength Integration (FSI)	0.15	0.02 – 0.28
Control Group (CON)	0.06	-0.07 – 0.18

Uninvolved Hip Abductor

Group	Value	95% CI
Functional Strength Integration (FSI)	0.14	0.04 – 0.24
Control Group (CON)	0.02	-0.07 – 0.11

Involved Quad Strength

Group	Value	95% CI
Functional Strength Integration (FSI)	0.64	0.43 – 0.86
Control Group (CON)	0.54	0.34 – 0.75

Uninvolved Quad Strength

Group	Value	95% CI
Functional Strength Integration (FSI)	0.31	0.09 – 0.53
Control Group (CON)	0.23	0.03 – 0.44

Involved Hamstring

Group	Value	95% CI
Functional Strength Integration (FSI)	0.24	0.14 – 0.34
Control Group (CON)	0.18	0.08 – 0.28

Uninvolved Hamstring

Group	Value	95% CI
Functional Strength Integration (FSI)	0.09	-0.01 – 0.20
Control Group (CON)	0.06	-0.04 – 0.16

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

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 durin

Group	Value	95% CI
Functional Strength Integration (FSI)	4.27	2.09 – 6.46
Control Group (CON)	2.81	0.80 – 4.81

Peak Internal Hip Abduction Moment Secondary · Change in moment from baseline to intervention end-point (after 8 week intervention; POST2)

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 dur

Involved Hip Abduction Moment

Group	Value	95% CI
Functional Strength Integration (FSI)	3.44	1.04 – 5.84
Control Group (CON)	0.62	-1.62 – 2.85

Uninvolved Hip Abduction Moment

Group	Value	95% CI
Functional Strength Integration (FSI)	3.27	1.23 – 5.30
Control Group (CON)	0.42	-1.50 – 2.32

ActiGraph Secondary · Change in physical activity from baseline to intervention end-point (after 8 week intervention; POST2)

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).

Group	Value	95% CI
Functional Strength Integration (FSI)	892	152 – 1631
Control Group (CON)	1014	306 – 1722

Veterans RAND 12-item Health Survey (VR-12) Secondary · Change in VR-12 from baseline to intervention end-point (after 8 week intervention; POST2)

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

Physical Component Score

Group	Value	95% CI
Functional Strength Integration (FSI)	15.2	12.7 – 17.7
Control Group (CON)	16.4	14.0 – 18.8

Mental Component Score

Group	Value	95% CI
Functional Strength Integration (FSI)	4.16	2.02 – 6.30
Control Group (CON)	3.82	1.78 – 5.86

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Secondary · Change in WOMAC from baseline to intervention end-point (after 8 week intervention; POST2)

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).

Group	Value	95% CI
Functional Strength Integration (FSI)	-35.0	-39.2 – 30.9
Control Group (CON)	-38.4	-42.4 – -34.5

Patient Activation Measure (PAM) Secondary · Assessed at baseline only

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: tak

Continuous

Group	Value	95% CI
Functional Strength Integration (FSI)	71.3	± 12.7
Control Group (CON)	70.6	± 14.2

PAM Level

Group	Value	95% CI
Functional Strength Integration (FSI)	3.34	± 0.57
Control Group (CON)	3.27	± 0.70

Patient Activation Measure (PAM) Categorical Secondary · Assessed at baseline only

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

Categorical Level 2

Group	Value	95% CI
Functional Strength Integration (FSI)	2
Control Group (CON)	7

Categorical Level 3

Group	Value	95% CI
Functional Strength Integration (FSI)	25
Control Group (CON)	22

Categorical Level 4

Group	Value	95% CI
Functional Strength Integration (FSI)	17
Control Group (CON)	20

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Functional Strength Integration (FSI)

Serious: 0/45 (0%)

Deaths: 0/45

Control Group (CON)

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (1 terms — click to expand)

Reaction	System	Functional Strength Integr…	Control Group (CON)
Falls	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT02920866 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.