Hip OsteoarthritisNCT06744582
Estimating VO2 Max and Recovery
An observational study of Hip Osteoarthritis, run by Bournemouth University at 2 sites in United Kingdom.
Trial summary
The study aims to estimate VO2 max levels at pre- and post-operative timepoints before and after hip arthroplasty surgery, using non-exercise-based measurement methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- VO2 max
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 Mar 2025to 25 Mar 2026
- 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 undergoing Robot Assisted Total Hip Replacement at the Nuffield Health
Who may be able to join
- Male and female ≥ 18 years;
- Undergoing total hip replacement at Nuffield Hospital;
- Voluntary written Informed Consent obtained;
- Participant able to complete study follow-up.
Who cannot join
- Requiring revision hip arthroplasty;
- Patients with implanted electronic equipment, such as a pacemaker;
- Women judged by the Investigator to be of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period;
- Unable to provide informed consent (insufficient English, lives overseas, unable to return easily).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nuffield Health Hospital Bournemouth
Bournemouth, Dorset, BH1 1RW
Bournemouth University
Bournemouth, Dorset, BH12 2DR
About this study
Official title: Estimating VO2 Max and Recovery in Patients Undergoing Total Hip Arthroplasty: A Feasibility Study
The study aims to estimate VO2 max levels at pre- and post-operative timepoints before and after hip arthroplasty surgery, using non-exercise-based measurement methods.
Read the detailed description
This observational cohort study will measure an estimation of VO2 max prior to and following routine robotic arm assisted hip arthroplasty surgery, and examine its association with outcomes of recovery after surgery. Although VO2 max is usually measured using cardiopulmonary exercise testing, these tests are often unachievable for an elderly population with end stage hip osteoarthritis and in a lot of pain. For this reason, this study will estimate VO2 max using the Seismofit® System. This works by measuring vibrations arising from heart beats that are transmitted to the chest. The small Seismofit® device is battery powered, and uses Bluetooth to communicate the results to a smartphone app. The device is simply attached to the lower part of the participant's sternum using an adhesive patch and takes around 45 seconds to record the data.
The study will also assess recovery through measuring pain and functional ability via patient reported outcome measures (PROMs) and objective performance assessments. In addition, participants will be invited to wear activity monitors on their wrist prior to surgery, and for 12 weeks after surgery, to understand changes in physical activity and sleep patterns.
Patients undergoing a robot-assisted hip arthroplasty with Professor Middleton at the Nuffield Health Hospital will be invited to take part in the study by the clinical team at Nuffield, and will be given a patient information sheet. If they are interested in taking part in the study, they will be contacted by a member of the research team at BU and invited into ORI to give their informed consent. Once the participant has consented, they will undergo pre-surgery assessments. It is anticipated that it will take 12 months to recruit the 30 participants. Participants will then have follow-up study visits on Day-1 at Nuffield Hospital, and at 3-, 6-, and 12-weeks post-surgery at ORI. Data relating to surgery, discharge and medication will also be taken from routine data collected at Nuffield Hospital. Participants will continue to be followed up clinically as per standard care at Nuffield Hospital. Findings from this feasibility study will inform the design of future interventions to improve cardiovascular fitness in patients undergoing hip arthroplasty surgery.
- Conditions
- Hip Osteoarthritis
- Being tested
- VO2 max
- Keywords
- Osteoarthritis, Hip arthroplasty, Hip replacement, Musculoskeletal, VO2 max, Cardiovascular fitness
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VO2 maxOther
The aim of this study is to generate data on the estimation of natural variation in VO2 max changes before and after surgery using seismocardiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural variation in VO2 max
VO2 max will be estimated using seismocardiography prior to surgery, on day 1, and at 3 weeks, 6 weeks, and 12 weeks following surgery.
Measured: From enrollment to 12 weeks after surgery
Secondary outcomes (5)
Patient Reported Outcome Measure (PROM) - The Hip Disability and Osteoarthritis Outcome Score (HOOS)
The Hip Disability and Osteoarthritis Outcome Score (HOOS) will be assessed at pre-surgery, 3 weeks, 6 weeks, and 12 weeks following surgery. There are 5 subscales (pain, symptoms and stiffness, activities of daily living, function in sports and recreational activities, and quality of life), that are all scored individually on a scale of 0 to 100, with 0 indicating extreme symptoms and 100 indicating no symptoms.
Measured: From enrollment to 12 weeks after surgery
Functional Assessment - 30 Second Chair Stand Test
30s Chair Stand Test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6 weeks, and 12 weeks following surgery.
Measured: From enrollment to 12 weeks after surgery
Functional Assessment - 40 Metre Fast-Paced Walk Test
40m Fast-Paced Walk Test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6 weeks, and 12 weeks following surgery.
Measured: From enrollment to 12 weeks after surgery
Functional Assessment - Stair Climb Test
Stair Climb Test as recommended by the Osteoarthritis Research Society International (OARSI). Assessment will be done prior to surgery, and again at 3 weeks, 6 weeks, and 12 weeks following surgery.
Measured: From enrollment to 12 weeks after surgery
Monitoring of physical activity
Participants will be invited to wear an activity monitor on their wrist for at least three consecutive days prior to surgery, and for the 12 weeks following discharge. The Actiwatch device is a wrist-worn activity data recorder that records the amount of physical activity the patient does by measuring the motion in the wrist.
Measured: From enrollment to 12 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 posted20 Dec 2024
- Study start27 Mar 2025
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Nuffield Health Bournemouth
- Responsible party
- Principal investigator, Tom Wainwright, Bournemouth University
- Investigators
- Thomas W. Wainwright, Principal investigator, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744582
- Sponsor's protocol ID
- ORI/VO2/24
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating VO2 Max and Recovery in Patients Undergoing Total Hip Arthroplasty: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06744582
- Acronym / sponsor ID
- ORI/VO2/24
- Conditions
- Hip Osteoarthritis
- Keywords
- Osteoarthritis, Hip arthroplasty, Hip replacement, Musculoskeletal, VO2 max, Cardiovascular fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Nuffield Health Bournemouth
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 20 Dec 2024 (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.
The study aims to estimate VO2 max levels at pre- and post-operative timepoints before and after hip arthroplasty surgery, using non-exercise-based measurement methods.
Detailed description
This observational cohort study will measure an estimation of VO2 max prior to and following routine robotic arm assisted hip arthroplasty surgery, and examine its association with outcomes of recovery after surgery. Although VO2 max is usually measured using cardiopulmonary exercise testing, these tests are often unachievable for an elderly population with end stage hip osteoarthritis and in a lot of pain. For this reason, this study will estimate VO2 max using the Seismofit® System. This works by measuring vibrations arising from heart beats that are transmitted to the chest. The small Seismofit® device is battery powered, and uses Bluetooth to communicate the results to a smartphone app. The device is simply attached to the lower part of the participant's sternum using an adhesive patch and takes around 45 seconds to record the data.
The study will also assess recovery through measuring pain and functional ability via patient reported outcome measures (PROMs) and objective performance assessments. In addition, participants will be invited to wear activity monitors on their wrist prior to surgery, and for 12 weeks after surgery, to understand changes in physical activity and sleep patterns.
Patients undergoing a robot-assisted hip arthroplasty with Professor Middleton at the Nuffield Health Hospital will be invited to take part in the study by the clinical team at Nuffield, and will be given a patient information sheet. If they are interested in taking part in the study, they will be contacted by a member of the research team at BU and invited into ORI to give their informed consent. Once the participant has consented, they will undergo pre-surgery assessments. It is anticipated that it will take 12 months to recruit the 30 participants. Participants will then have follow-up study visits on Day-1 at Nuffield Hospital, and at 3-, 6-, and 12-weeks post-surgery at ORI. Data relating to surgery, discharge and medication will also be taken from routine data collected at Nuffield Hospital. Participants will continue to be followed up clinically as per standard care at Nuffield Hospital. Findings from this feasibility study will inform the design of future interventions to improve cardiovascular fitness in patients undergoing hip arthroplasty surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health
Key inclusion criteria (4 listed)
- Male and female ≥ 18 years;
- Undergoing total hip replacement at Nuffield Hospital;
- Voluntary written Informed Consent obtained;
- Participant able to complete study follow-up.
Key exclusion criteria (4 listed)
- Requiring revision hip arthroplasty;
- Patients with implanted electronic equipment, such as a pacemaker;
- Women judged by the Investigator to be of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period;
- Unable to provide informed consent (insufficient English, lives overseas, unable to return easily).
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 |
|---|---|---|
| VO2 maxThe aim of this study is to generate data on the estimation of natural variation in VO2 max changes before and after surgery using seismocardiography. | Other | – |
Primary outcome
Natural variation in VO2 max
Time frame: From enrollment to 12 weeks after surgery
VO2 max will be estimated using seismocardiography prior to surgery, on day 1, and at 3 weeks, 6 weeks, and 12 weeks following surgery.
5 secondary outcomes
Patient Reported Outcome Measure (PROM) - The Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: From enrollment to 12 weeks after surgery
Functional Assessment - 30 Second Chair Stand Test
Time frame: From enrollment to 12 weeks after surgery
Functional Assessment - 40 Metre Fast-Paced Walk Test
Time frame: From enrollment to 12 weeks after surgery
Functional Assessment - Stair Climb Test
Time frame: From enrollment to 12 weeks after surgery
Monitoring of physical activity
Time frame: From enrollment to 12 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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Thomas W. Wainwright principal investigator
Bournemouth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis, run by Bournemouth University at 2 sites in United Kingdom.
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 4 inclusion and 4 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Natural variation in VO2 max (time frame: From enrollment to 12 weeks after surgery). 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 22 Apr 2026.