Total Hip ArthroplastyNCT03584451
Evaluation of the Effect of Rehabilitation Sport After Total Hip Arthroplasty (THA)
A study testing rehabilitation sport in people with Total Hip Arthroplasty and Osteoarthritis, Hip, run by Technische Universität Dresden.
Trial summary
160 patients who received a total hip arthroplasty (THA) were included and randomized to receive specific rehabilitation sport (RS) or not (control) in addition to a conventional rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty, Osteoarthritis, Hip, Sports Physical Therapy
- What is being tested?
- rehabilitation sport
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-complicated THA
- written informed consent
Who cannot join
- complicated THA
- partial weight-bearing after surgery
- cardial comorbidities
About this study
Official title: Randomized, Clinical Survey for Evaluating the Effect of Rehabilitation Sport on Patients Who Underwent Total Hip Arthroplasty (THA)
160 patients who received a total hip arthroplasty (THA) were included and randomized to receive specific rehabilitation sport (RS) or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements.
Read the detailed description
In Germany, rehabilitation sport (RS) is a reimbursed postoperative measure in order to support socio-professional reintegration and self-help.
160 patients who received a primary total hip arthroplasty (THA) were included and randomized to receive specific RS or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements. The goal of the study was to prospectively randomized evaluate the effect of RS on hip-related muscular strength, endurance and postural stability on patients who underwent THA.
- Being tested
- rehabilitation sport
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation sportBehavioural
rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| with rehabilitation sport | Active comparator | rehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively Receives: Behavioral: rehabilitation sport |
| without rehabilitation sport | No intervention | no further rehabilitation program after THA |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip-related muscular strength
hip-related muscular strength measured with isokinetic dynamometry
Measured: change from baseline (6 weeks) at 6 months after THA
Secondary outcomes (11)
Hip pain - WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (worst=0, best=100)
Measured: change from 6 months to 12 months after THA
Physical function hip - WOMAC
WOMAC Total Score (worst=0, best=100)
Measured: change from 6 months to 12 months after THA
Physical function hip - HHS
Harris-Hip-Score (worst=0, best=100)
Measured: change from 6 months to 12 months after THA
Physical Activity
University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)
Measured: change from 6 months to 12 months after THA
health related Quality of life
EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1), EQ-VAS (worst=0, best=100)
Measured: change from 6 months to 12 months after THA
Hip pain
Visual Analogue Scale (worst=0, best=10)
Measured: change from 6 months to 12 months after THA
cardiovascular endurance
cardiovascular endurance via lactate measurements
Measured: change from baseline (6 weeks) at 6 months after THA
cardiovascular endurance
cardiovascular endurance via lactate measurements
Measured: change from baseline (6 weeks) at 12 months after THA
postural control
postural control with a force measuring platform
Measured: change from baseline (6 weeks) at 6 months after THA
postural control
postural control with a force measuring platform
Measured: change from baseline (6 weeks) at 12 months after THA
hip-related muscular strength
hip-related muscular strength measured with isokinetic dynamometry
Measured: change from baseline (6 weeks) at 12 months after THA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study startFeb 2015
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584451
- Sponsor's protocol ID
- rehasport after THA
- Status last verified
- Aug 2018
- First submitted
- 4 Jun 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Clinical Survey for Evaluating the Effect of Rehabilitation Sport on Patients Who Underwent Total Hip Arthroplasty (THA)
- ClinicalTrials.gov ID
- NCT03584451
- Acronym / sponsor ID
- rehasport after THA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Jul 2018 (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.
160 patients who received a total hip arthroplasty (THA) were included and randomized to receive specific rehabilitation sport (RS) or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements.
Detailed description
In Germany, rehabilitation sport (RS) is a reimbursed postoperative measure in order to support socio-professional reintegration and self-help.
160 patients who received a primary total hip arthroplasty (THA) were included and randomized to receive specific RS or not (control) in addition to a conventional rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. Strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements. The goal of the study was to prospectively randomized evaluate the effect of RS on hip-related muscular strength, endurance and postural stability on patients who underwent THA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with rehabilitation sport | Active comparator | Behavioral: rehabilitation sportrehabilitation sport over 52 weeks after THA, start 6 weeks postoperatively |
| without rehabilitation sport | No intervention | –no further rehabilitation program after THA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-complicated THA
- written informed consent
Key exclusion criteria (3 listed)
- complicated THA
- partial weight-bearing after surgery
- cardial comorbidities
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 |
|---|---|---|
| rehabilitation sportrehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively | Behavioural | with rehabilitation sport |
Primary outcome
hip-related muscular strength
Time frame: change from baseline (6 weeks) at 6 months after THA
hip-related muscular strength measured with isokinetic dynamometry
11 secondary outcomes
Hip pain - WOMAC
Time frame: change from 6 months to 12 months after THA
Physical function hip - WOMAC
Time frame: change from 6 months to 12 months after THA
Physical function hip - HHS
Time frame: change from 6 months to 12 months after THA
Physical Activity
Time frame: change from 6 months to 12 months after THA
health related Quality of life
Time frame: change from 6 months to 12 months after THA
Hip pain
Time frame: change from 6 months to 12 months after THA
cardiovascular endurance
Time frame: change from baseline (6 weeks) at 6 months after THA
cardiovascular endurance
Time frame: change from baseline (6 weeks) at 12 months after THA
postural control
Time frame: change from baseline (6 weeks) at 6 months after THA
postural control
Time frame: change from baseline (6 weeks) at 12 months after THA
hip-related muscular strength
Time frame: change from baseline (6 weeks) at 12 months after THA
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 17 Aug 2018.
- Individual participant dataSharing planned: No. no plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation sport in people with Total Hip Arthroplasty and Osteoarthritis, Hip, run by Technische Universität Dresden.
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 2 inclusion and 3 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
hip-related muscular strength (time frame: change from baseline (6 weeks) at 6 months after THA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2018.