Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty

Study Overview
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Brief Summary
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This pilot cluster-randomized, two-arm parallel-group controlled trial, aims at enhancing the understanding of the effects of real-time feedback on functional deficits as knee valgus thrust, pelvic drop, and lateral trunk lean after total hip arthroplasty. Biomechanical and patient-reported outcomes will be assessed after a total hip arthroplasty as well as at three and six months follow-ups. The primary research question is, whether digital real-time feedback supported home-exercising improves the control of the frontal knee range of motion, pelvic obliquity, and lateral trunk lean, superior to exercising supported by written instructions as comparator. The secondary aspect focuses on potential differences between groups concerning aspects of quality of life, function, and physical activity. Tertiary functional outcomes between groups will be compared for reasons of quantification movement quality.

Official Title
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Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: a Pilot Cluster-randomized Controlled Trial

Conditions
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Hip Replacement

Intervention / Treatment
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* Other: Supervised group exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 50-75 years body mass index from 18.5 to 29.99 kg/m² able to walk without walking aids at baseline assessment scheduled for elective unilateral total hip arthroplasty surgery willing to comply with all study related procedures and provide informed consent Exclusion Criteria: symptoms of delayed healing concerning the implant cardio-respiratory symptoms limiting exercise therapy (for example severe heart disease) symptoms of musculoskeletal or cardio-respiratory overload neuro-motor diseases (for example previous Stroke, Multiple Sclerosis, Morbus Parkinson Disease) other reasons which would lead to obvious limitations concerning their participation in the intervention (for example severe contralateral osteoarthritis (OA), lower extremity fractures within previous 12 months, other elective lower extremity surgery within 6 months, inadequacy in German concerning questionnaires and exercise instructions, mentally unable to participate) non-adherence (see definition under therapeutic adherence).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster-randomized, two-arm parallel-group controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (IG)<br>IG will perform the home-exercise program supported by the digital real-time exercise feedback prototype for digitally guided training. | Other: Supervised group exercise therapy<br>* Participants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks.<br>|
| Active Comparator: Control Group (CG)<br>The CG will perform a usual care home-exercise by means of printed hand-outs describing each exercise. | Other: Supervised group exercise therapy<br>* Participants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion | Above listed angles derived from assessed Activities of Daily Living (ADL) tasks | Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) Hip Osteoarthritis Outcome Score (HOOS) Short-Form-Health Survey (SF12) International Physical Activity Questionnaire - short form (IPAQ) if applicable: Knee Injury and Osteoarthritis Outcome Score (KOOS) |  | Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip replacement, exercise therapy, real-time feedback, movement analysis