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

Hip Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161194
• Other study ID #: CIP_SETT_RCT-THA
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: FH Campus Wien, University of Applied Sciences
• Contact: Klaus Widhalm
• Phone: +43 1 6066877 4743
• Email: klaus.widhalm[@]fh-campuswien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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").

Related Conditions & MeSH terms

• Hip Replacement

Intervention

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

Locations

Country	Name	City	State
Austria	Orthopaedic Hospital Vienna Speising	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Klaus Widhalm	Orthopedic Hospital Vienna Speising

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3D-movement-analysis parameters (kinematic, kinetic, spatio-temporal)		Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery
Primary	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	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