VO2 max
OtherThe aim of this study is to generate data on the estimation of natural variation in VO2 max changes before and after surgery using seismocardiography.
NCT Number: NCT06744582
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Bournemouth University, Bournemouth, Dorset, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From enrollment to 12 weeks after surgery
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.
Time frame: From enrollment to 12 weeks after surgery
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.
Time frame: From enrollment to 12 weeks after surgery
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.
Time frame: From enrollment to 12 weeks after surgery
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.
Time frame: From enrollment to 12 weeks after surgery
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.
Bournemouth University
Other
Estimating VO2 Max and Recovery in Patients Undergoing Total Hip Arthroplasty: A Feasibility Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06783452
Arthritis, Behavior
Izmir, Turkey (Türkiye)
View Trial DetailsNCT07186374
Arthritis, Hip Osteoarthritis
Artvin, Turkey (Türkiye)
View Trial DetailsNCT06734845
Arthritis, Deficiency Diseases
Hartford, Connecticut, United States
View Trial DetailsNCT05164575
Arthritis, Hip Osteoarthritis
Edmonton, Alberta, Canada
View Trial Details