Hip ReplacementNCT06161194
Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty
A study testing Supervised group exercise therapy in people with Hip Replacement, run by Klaus Widhalm at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hip Replacement
- What is being tested?
- Supervised group exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jan 2024to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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").
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: a Pilot Cluster-randomized Controlled Trial
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
- Being tested
- Supervised group exercise therapy
- Keywords
- hip replacement, exercise therapy, real-time feedback, movement analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised group exercise therapyOther
Participants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Experimental | IG will perform the home-exercise program supported by the digital real-time exercise feedback prototype for digitally guided training. Receives: 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. Receives: Other: Supervised group exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start10 Jan 2024
- Primary completion15 Apr 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster-randomized, two-arm parallel-group controlled trial
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klaus Widhalm
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Hospital Vienna Speising
- Responsible party
- Sponsor-investigator, Klaus Widhalm, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Investigators
- Klaus Widhalm, Study director, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161194
- Sponsor's protocol ID
- CIP_SETT_RCT-THA
- Status last verified
- Aug 2025
- First submitted
- 30 Nov 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Widhalm K, Berger-Maul L, Penasso H, Durstberger S, Putz P, Leder-Berg S, Kainz H, Augat P. Efficacy of real-time feedback exercise therapy in patients following total hip arthroplasty: a pilot cluster-randomized controlled trial. BMC Musculoskelet Disord. 2026 Aug 4;27(1):946. doi: 10.1186/s12891-026-10321-1.
PubMed 42977959Widhalm 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.
PubMed 39163589
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: a Pilot Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06161194
- Acronym / sponsor ID
- CIP_SETT_RCT-THA
- Conditions
- Hip Replacement
- Keywords
- hip replacement, exercise therapy, real-time feedback, movement analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Klaus WidhalmUniversity, hospital or other
- Collaborators
- Orthopedic Hospital Vienna Speising
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster-randomized, two-arm parallel-group controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Other: Supervised group exercise therapyIG will perform the home-exercise program supported by the digital real-time exercise feedback prototype for digitally guided training. |
| Control Group (CG) | Active comparator | Other: Supervised group exercise therapyThe CG will perform a usual care home-exercise by means of printed hand-outs describing each exercise. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised group exercise therapyParticipants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks. | Other | Control Group (CG), Intervention Group (IG) |
Primary outcome
Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion
Time frame: 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
1 secondary outcome
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)
Time frame: Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 42977959Widhalm K, Berger-Maul L, Penasso H, Durstberger S, Putz P, Leder-Berg S, Kainz H, Augat P. Efficacy of real-time feedback exercise therapy in patients following total hip arthroplasty: a pilot cluster-randomized controlled trial. BMC Musculoskelet Disord. 2026 Aug 4;27(1):946. doi: 10.1186/s12891-026-10321-1.
- Derived from this study: PubMed 39163589Widhalm 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.
- Individual participant dataSharing planned: Yes
Related trials for Hip Replacement
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The restor3d Outcomes Registry
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Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Widhalm study director
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised group exercise therapy in people with Hip Replacement, run by Klaus Widhalm at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion (time frame: Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06161194, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.