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

NCT06161194 | Completed DMC

• 1 other identifier: CIP_SETT_RCT-THA
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Replacement

Keywords

hip replacement; exercise therapy; real-time feedback; movement analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• 3D-movement-analysis parameters (kinematic, kinetic, spatio-temporal)

  Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

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

Control Group (CG)

ACTIVE COMPARATOR

The CG will perform a usual care home-exercise by means of printed hand-outs describing each exercise.

Other: Supervised group exercise therapy

Interventions

Supervised group exercise therapy OTHER

Participants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks.

Control Group (CG); Intervention Group (IG)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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").

Sponsors & Collaborators

• Klaus Widhalm: lead
• Orthopedic Hospital Vienna Speising: collaborator

Study Sites (1)

Orthopaedic Hospital Vienna Speising

Vienna, 1130, Austria

Location

Related Publications (1)

• Widhalm K, Maul L, Durstberger S, Putz P, Leder-Berg S, Kainz H, Augat P. Efficacy of Real-Time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: Protocol for a Pilot Cluster-Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 20;13:e59755. doi: 10.2196/59755.

  PMID: 39163589 DERIVED

Study Officials

• Klaus Widhalm

  FH Campus Wien, University of Applied Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be randomly assigned to IG or CG after baseline assessment. Due to the nature of the studied conditions, it will not be possible to blind researchers or participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of study

Model Details: cluster-randomized, two-arm parallel-group controlled trial

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: January 10, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 5, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The study protocol including the statistic analysis plan will be submitted for publication in Trials Journal at begin of 2024. The final results will be submitted for publication to a relevant journal by the end of 2025.
• Access Criteria: Open Access publication

Locations

AU (1)