NCT06744582

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 27, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

December 16, 2024

Last Update Submit

April 21, 2026

Conditions

Keywords

OsteoarthritisHip arthroplastyHip replacementMusculoskeletalVO2 maxCardiovascular fitness

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to 12 weeks after surgery

Secondary Outcomes (5)

  • Patient Reported Outcome Measure (PROM) - The Hip Disability and Osteoarthritis Outcome Score (HOOS)

    From enrollment to 12 weeks after surgery

  • Functional Assessment - 30 Second Chair Stand Test

    From enrollment to 12 weeks after surgery

  • Functional Assessment - 40 Metre Fast-Paced Walk Test

    From enrollment to 12 weeks after surgery

  • Functional Assessment - Stair Climb Test

    From enrollment to 12 weeks after surgery

  • Monitoring of physical activity

    From enrollment to 12 weeks after surgery

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing Robot Assisted Total Hip Replacement at the Nuffield Health

You may qualify if:

  • Male and female ≥ 18 years;
  • Undergoing total hip replacement at Nuffield Hospital;
  • Voluntary written Informed Consent obtained;
  • Participant able to complete study follow-up.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nuffield Health Hospital Bournemouth

Bournemouth, Dorset, BH1 1RW, United Kingdom

Location

Bournemouth University

Bournemouth, Dorset, BH12 2DR, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Thomas W. Wainwright

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopaedics

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 20, 2024

Study Start

March 27, 2025

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations