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

Not Applicable

Active, not recruiting

• Conditions: Hip Replacement
• Interventions: Other: Supervised group exercise therapy

• Registration Number: NCT06161194
• Lead Sponsor: Klaus Widhalm

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-07
• Study Start: 2024-01-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2024-11-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

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").

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (IG)	Supervised group exercise therapy	IG will perform the home-exercise program supported by the digital real-time exercise feedback prototype for digitally guided training.
Control Group (CG)	Supervised group exercise therapy	The CG will perform a usual care home-exercise by means of printed hand-outs describing each exercise.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Orthopaedic Hospital Vienna Speising; 🇦🇹 Vienna, Austria