Arthroplasty, Replacement, HipPHETHAS-1NCT03109821
Home-based Rehabilitation Following a Total Hip Replacement
An observational study of Arthroplasty, Replacement, Hip, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
In this study we will investigate the relation between performed exercise dose and recovery after total hip replacement (THA). A dose-response relationship is hypothesized. It is the primary objective to indicate the preliminary efficacy of home-based rehabilitation using elastic band exercise on performance-based… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Home-based exercise
- How many people
- 94 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Apr 2017to 8 Jan 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage hip osteoarthritis, who are scheduled for primary THA at the Elective Surgery Centre at the public hospital, Silkeborg Regional Hospital.
Who may be able to join
- Above 18 years
- Scheduled for a primary THA, at Elective Surgery Centre, due to osteoarthritis
- Able to understand written and spoken Danish
Who cannot join
- Referral to supervised rehabilitation in the municipality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Rehabilitation Following a Total Hip Replacement - do Patients Follow the Exercise Prescription and How Does it Relate to Postoperative Recovery? The Pragmatic Home-Based Exercise After Total Hip Arthroplasty Silkeborg 1 (PHETHAS-1) Trial
In this study we will investigate the relation between performed exercise dose and recovery after total hip replacement (THA). A dose-response relationship is hypothesized.
It is the primary objective to indicate the preliminary efficacy of home-based rehabilitation using elastic band exercise on performance-based function after THA, based on the relationship between the performed exercise dose (objectively quantified time under tension summary dose) and the change in 40 meter maximal gait speed (performance-based function) from 3 (start of intervention) to 10 weeks (end of intervention) after surgery.
Read the detailed description
The study is a pragmatic, single center, prospective cohort study (single cohort) to be conducted in Silkeborg, Denmark. The outcomes will be collected in the period from 3 to 10 weeks after surgery by an assessor blinded to exercise compliance. The study will adhere methodologically to the STROBE guidelines and checklist for prospective cohort studies (www.strobe-statement.org).
The study design and completion is conducted in a research collaboration between the Interdisciplinary Research Unit at Elective Surgery Centre based at Silkeborg Regional Hospital and Physical Medicine \& Rehabilitation Research - Copenhagen (PMR-C) based at Hvidovre Hospital.
Primary objective, eligibility criteria, exposure/intervention and outcome measures are entered elsewhere. At June 28, 2017, two outcome measures were added to the study. At 10 weeks after surgery, patients will be asked both to describe change in hip problems (from preoperatively to 10 weeks after surgery) and to describe their perception of outcome after surgery. The outcome measures will be used for exploratory analysis of patient acceptable symptom state (PASS) and minimal clinically important improvement (MCII)
Primary analysis:
A simple linear regression analysis will be performed to evaluate the association between performed exercise dose and change in score on gait speed. Furthermore descriptive statistics will be used to quantify exercise compliance and to indicate the exercise dosage with the greatest response. Patients will be divided into four compliance-quartiles and summary statistics of the primary outcome (change in gait speed) will be presented graphically to illustrate possible dose-response relationship.
Secondary analyses:
For change in patient-reported function the analysis will be similar to the analysis for change in gait speed. Summary statistics on the rest of the secondary outcomes will be presented for the compliance-quartiles.
In a multiple regression analysis the association between gait speed (at 10 weeks follow up) and self-efficacy, 24-hour physical activity, performed exercise dose and gait speed (at baseline) will be analyzed.
Furthermore summary statistics will be presented for demographic data and other pre-specified outcomes.
Additionally, an embedded qualitative study will be performed to explore motivation and barriers related to exercise compliance. This study will be reported in a secondary paper with a clear reference to the primary trial and trial registration.
Regional Hospital Central Jutland and The Danish Rheumatism Association is partly funding the salary for physiotherapists involved in the study. Further external funding will be applied for.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Home-based exercise
- Keywords
- Exercise Therapy, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exerciseOther
The intervention reflects the standard rehabilitation practice at Elective Surgery Centre. 3 weeks after surgery the patients will receive a thorough instruction and supervision in the strength training exercises that they are to perform without supervision at their own homes the following 7 weeks. The instruction is conducted one-to-one by physiotherapists and supported by an instruction booklet with written and illustrated exercise descriptions. The exercises included are: hip abduction, flexion and extension with elastic band resistance and sit-to-stand and one-legged stance. The prescribed training load will be two sets with repetitions to failure and a relative load of 10 to 20 RM (Repetition Maximum), performed every second day (3-4 times a week).
Exposure: Performed exercise dose will be quantified as the total physiological exercise stimulus (Time under tension summary dose) recorded by a sensor (BandCizer) attached to the elastic exercise band.
| Study group | Role | What they receive |
|---|---|---|
| THA patients | Not described Receives: Other: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
Measured by the 40m fast-paced walk test (continous, m/sec)
Measured: Change from 3 to 10 weeks after surgery.
Secondary outcomes (11)
Gait speed
Measured by the 40m fast-paced walk test (continous, m/sec)
Measured: 10 weeks after surgery
Change in patient-reported function
Measured by the ADL (Activities of Daily Living) subscale of Hip disability and Osteoarthritis Outcome Score (HOOS). HOOS is a disease-specific patient-reported outcome measure (continous)
Measured: Change from 3 to 10 weeks after surgery.
Change in patient-reported symptoms
Measured by the symptoms subscale of HOOS (continous)
Measured: Change from 3 to 10 weeks after surgery.
Change in patient-reported pain
Measured by the pain subscale of HOOS (continous)
Measured: Change from 3 to 10 weeks after surgery.
Change in patient-reported hip related quality of life
Measured by the quality of life subscale (QoL) of HOOS (continous)
Measured: Change from 3 to 10 weeks after surgery.
Change in lower-extremity function
Measured by the Chair stand test (The maximal number of rises from a chair within 30 seconds) (continous)
Measured: Change from 3 to 10 weeks after surgery
Change in hip abductor muscle strength
Test of isometric muscle strength in hip abduction in the operated leg. The hand-held dynamometer Power Track II Commander will be used to assess this using standardized test procedures (continous, Nm/kg)
Measured: Change from 3 to 10 weeks after surgery
Change in hip flexor muscle strength
Test of isometric muscle strength in hip flexion in the operated leg. The hand-held dynamometer Power Track II Commander will be used to assess this using standardized test procedures (continous, Nm/kg)
Measured: Change from 3 to 10 weeks after surgery
Self-efficacy
The general self-efficacy scale will be used to measure self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments (continous)
Measured: 3 weeks after surgery
24-hour physical activity (mean upright time).
An ActivPAL movement-sensor will be used to measure mean time per day in upright position (standing and walking) based on 7 days of data collection. The sensor will be applied 3 weeks after surgery and used the following week (continous, min/day)
Measured: 4 weeks after surgery
24-hour physical activity (mean number of steps)
An ActivPAL movement-sensor will be used to measure mean number of steps per day based on 7 days of data collection. The sensor will be applied 3 weeks after surgery and used the following week (continous, min/day)
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start21 Apr 2017
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
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 Arthroplasty, Replacement, HipStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lone R Mikkelsen, PhD, Principal investigator, Silkeborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109821
- Sponsor's protocol ID
- 654894
- Acronym
- PHETHAS-1
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Madsen MN, Mikkelsen LR, Rathleff MS, Thorborg K, Kallemose T, Bandholm T. Hip strengthening exercise dosage is not associated with clinical improvements after total hip arthroplasty - a prospective cohort study (the PHETHAS-1 study). BMC Musculoskelet Disord. 2024 Nov 19;25(1):928. doi: 10.1186/s12891-024-08057-x.
PubMed 39563311Mikkelsen LR, Madsen MN, Rathleff MS, Thorborg K, Rossen CB, Kallemose T, Bandholm T. Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1). F1000Res. 2019 Jun 25;8:965. doi: 10.12688/f1000research.19570.2. eCollection 2019.
PubMed 31448107
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Rehabilitation Following a Total Hip Replacement - do Patients Follow the Exercise Prescription and How Does it Relate to Postoperative Recovery? The Pragmatic Home-Based Exercise After Total Hip Arthroplasty Silkeborg 1 (PHETHAS-1) Trial
- ClinicalTrials.gov ID
- NCT03109821
- Acronym / sponsor ID
- PHETHAS-1 / 654894
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Exercise Therapy, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 12 Apr 2017 (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.
In this study we will investigate the relation between performed exercise dose and recovery after total hip replacement (THA). A dose-response relationship is hypothesized.
It is the primary objective to indicate the preliminary efficacy of home-based rehabilitation using elastic band exercise on performance-based function after THA, based on the relationship between the performed exercise dose (objectively quantified time under tension summary dose) and the change in 40 meter maximal gait speed (performance-based function) from 3 (start of intervention) to 10 weeks (end of intervention) after surgery.
Detailed description
The study is a pragmatic, single center, prospective cohort study (single cohort) to be conducted in Silkeborg, Denmark. The outcomes will be collected in the period from 3 to 10 weeks after surgery by an assessor blinded to exercise compliance. The study will adhere methodologically to the STROBE guidelines and checklist for prospective cohort studies (www.strobe-statement.org).
The study design and completion is conducted in a research collaboration between the Interdisciplinary Research Unit at Elective Surgery Centre based at Silkeborg Regional Hospital and Physical Medicine \& Rehabilitation Research - Copenhagen (PMR-C) based at Hvidovre Hospital.
Primary objective, eligibility criteria, exposure/intervention and outcome measures are entered elsewhere. At June 28, 2017, two outcome measures were added to the study. At 10 weeks after surgery, patients will be asked both to describe change in hip problems (from preoperatively to 10 weeks after surgery) and to describe their perception of outcome after surgery. The outcome measures will be used for exploratory analysis of patient acceptable symptom state (PASS) and minimal clinically important improvement (MCII)
Primary analysis:
A simple linear regression analysis will be performed to evaluate the association between performed exercise dose and change in score on gait speed. Furthermore descriptive statistics will be used to quantify exercise compliance and to indicate the exercise dosage with the greatest response. Patients will be divided into four compliance-quartiles and summary statistics of the primary outcome (change in gait speed) will be presented graphically to illustrate possible dose-response relationship.
Secondary analyses:
For change in patient-reported function the analysis will be similar to the analysis for change in gait speed. Summary statistics on the rest of the secondary outcomes will be presented for the compliance-quartiles.
In a multiple regression analysis the association between gait speed (at 10 weeks follow up) and self-efficacy, 24-hour physical activity, performed exercise dose and gait speed (at baseline) will be analyzed.
Furthermore summary statistics will be presented for demographic data and other pre-specified outcomes.
Additionally, an embedded qualitative study will be performed to explore motivation and barriers related to exercise compliance. This study will be reported in a secondary paper with a clear reference to the primary trial and trial registration.
Regional Hospital Central Jutland and The Danish Rheumatism Association is partly funding the salary for physiotherapists involved in the study. Further external funding will be applied for.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THA patients | – | Other: Home-based exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage hip osteoarthritis, who are scheduled for primary THA at the Elective Surgery Centre at the public hospital, Silkeborg Regional Hospital.
Key inclusion criteria (3 listed)
- Above 18 years
- Scheduled for a primary THA, at Elective Surgery Centre, due to osteoarthritis
- Able to understand written and spoken Danish
Key exclusion criteria (1 listed)
- Referral to supervised rehabilitation in the municipality
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 |
|---|---|---|
| Home-based exerciseThe intervention reflects the standard rehabilitation practice at Elective Surgery Centre. 3 weeks after surgery the patients will receive a thorough instruction and supervision in the strength training exercises that they are to perform without supervision at their own homes the following 7 weeks. The instruction is conducted one-to-one by physiotherapists and supported by an instruction booklet with written and illustrated exercise descriptions. The exercises included are: hip abduction, flexion and extension with elastic band resistance and sit-to-stand and one-legged stance. The prescribed training load will be two sets with repetitions to failure and a relative load of 10 to 20 RM (Repetition Maximum), performed every second day (3-4 times a week). Exposure: Performed exercise dose will be quantified as the total physiological exercise stimulus (Time under tension summary dose) recorded by a sensor (BandCizer) attached to the elastic exercise band. | Other | THA patients |
Primary outcome
Change in gait speed
Time frame: Change from 3 to 10 weeks after surgery.
Measured by the 40m fast-paced walk test (continous, m/sec)
11 secondary outcomes
Gait speed
Time frame: 10 weeks after surgery
Change in patient-reported function
Time frame: Change from 3 to 10 weeks after surgery.
Change in patient-reported symptoms
Time frame: Change from 3 to 10 weeks after surgery.
Change in patient-reported pain
Time frame: Change from 3 to 10 weeks after surgery.
Change in patient-reported hip related quality of life
Time frame: Change from 3 to 10 weeks after surgery.
Change in lower-extremity function
Time frame: Change from 3 to 10 weeks after surgery
Change in hip abductor muscle strength
Time frame: Change from 3 to 10 weeks after surgery
Change in hip flexor muscle strength
Time frame: Change from 3 to 10 weeks after surgery
Self-efficacy
Time frame: 3 weeks after surgery
24-hour physical activity (mean upright time).
Time frame: 4 weeks after surgery
24-hour physical activity (mean number of steps)
Time frame: 4 weeks after 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 17 Mar 2020.
- Derived from this study: PubMed 39563311Madsen MN, Mikkelsen LR, Rathleff MS, Thorborg K, Kallemose T, Bandholm T. Hip strengthening exercise dosage is not associated with clinical improvements after total hip arthroplasty - a prospective cohort study (the PHETHAS-1 study). BMC Musculoskelet Disord. 2024 Nov 19;25(1):928. doi: 10.1186/s12891-024-08057-x.
- Derived from this study: PubMed 31448107Mikkelsen LR, Madsen MN, Rathleff MS, Thorborg K, Rossen CB, Kallemose T, Bandholm T. Pragmatic Home-Based Exercise after Total Hip Arthroplasty - Silkeborg: Protocol for a prospective cohort study (PHETHAS-1). F1000Res. 2019 Jun 25;8:965. doi: 10.12688/f1000research.19570.2. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
Lone R Mikkelsen, PhD principal investigator
Silkeborg Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Hip, run by Central Jutland Regional Hospital at 1 site in Denmark.
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 3 inclusion and 1 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 Mar 2020. 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 Denmark. 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?
Change in gait speed (time frame: Change from 3 to 10 weeks after 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 NCT03109821, 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 17 Mar 2020; AzTrials last refreshed its copy on 1 Nov 2026.