Physical Activity, Knee Joint Loading and Joint Health

March 12, 2024 updated by: Karl Morgan, University of Bath

Investigating the Associations Between Physical Activity, Knee Joint Loading and Joint Health Following Anterior Cruciate Ligament Reconstruction

The purpose of this study is to investigate the association between time spent in moderate to vigorous physical activity and markers of cartilage metabolism in the years following anterior cruciate ligament reconstruction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Participants attend the laboratory on two or three occasions and wear accelerometers for the 10 days in between the first and second laboratory session. The first laboratory session involves urine sample collection, the completion of questionnaires, blood sample collection, acquisition of cross-sectional images of the thigh and calf, and a whole-body composition scan. The researchers will use the accelerometers at the wrist to measure time spent in moderate to vigorous physical activity, and the accelerometers at the ankle as an analogue for knee joint loading. The second laboratory session will consist of a 30-minute run on an instrumented treadmill (measures force of each step taken) whilst wearing non-invasive reflective markers, electromyography devices, and an accelerometer at the ankle. Participants are also invited to undergo optional repeated blood sampling to measure levels of markers of cartilage production and breakdown during rest and in response to a 30-minute run. If participants volunteer for the optional repeated blood sampling, they will be asked to attend a third laboratory session where blood samples will be taken at 24 hours after the run in the second laboratory session.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Karl Morgan, MSc
  • Phone Number: +44 (0)7853220282
  • Email: kdm40@bath.ac.uk

Study Contact Backup

  • Name: Jean-Philippe Walhin, PhD
  • Phone Number: +44 (0)1225386478
  • Email: jpw23@bath.ac.uk

Study Locations

  • United Kingdom
      • Bath, United Kingdom
        • Recruiting
        • University of Bath
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Young men and women who are aged 18-39 years old and are 1-7 years following their anterior cruciate ligament injury and surgery.

Description

Inclusion Criteria:

  1. 18-39 years old (i.e., ≥18 and <40 years old)
  2. Had an anterior cruciate ligament injury and reconstruction 1-7 years ago (i.e., ≥1 and ≤7 years ago)
  3. Can have sustained damage to meniscus or cartilage, or sustained bone bruising when injured anterior cruciate ligament
  4. Can participate regardless of the type of reconstruction surgery and if undergone meniscectomy
  5. Completed anterior cruciate ligament reconstruction rehabilitation and either a surgeon, doctor or physiotherapist has provided clearance to participate in physical activity
  6. Be able to attend the University of Bath within 2 hours of waking

Exclusion Criteria:

  1. Had another significant knee injury either before, at the same time, or after the anterior cruciate ligament injury (e.g., if they injured another ligament in their knee or had a fracture or dislocation)
  2. Injured the anterior cruciate ligament in both knees (bilateral ACL injury)
  3. Have/are experiencing a musculoskeletal, cardiovascular, respiratory, immune, metabolic or neurological disease or disorder
  4. Under 18 or over 39 (i.e., ≥40) years of age
  5. Body Mass Index ≥40 kg/m²
  6. Pregnancy
  7. Positive responses to the Physical Activity Readiness Questionnaire (aside from any involved knee joint issues)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intra-Articular Knee Injury
Forty men and women aged 18-45 years old who are 1-7 years following an intra-articular knee injury.
Controls
Forty men and women aged 18-45 years old who are matched to the injured group by age, sex and body mass index.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ratio of urine concentration of c-telopeptide of type II collagen to serum concentration of c-propeptide of type II procollagen
Time Frame: Day 1
Urine concentration of c-telopeptide of type II collagen (uCTX-II) is a marker of cartilage degradation. Serum concentration of c-propeptide of type II procollagen (sCP-II) is a marker of cartilage synthesis. The ratio between these two biomarkers as an indicator of knee joint health has previously been validated.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urine concentration of c-telopeptide of type II collagen
Time Frame: Day 1
Urine concentration of c-telopeptide of type II collagen (uCTX-II) is a marker of cartilage degradation.
Day 1
Serum concentration of c-propeptide of type II procollagen
Time Frame: Day 1
Serum concentration of c-propeptide of type II procollagen (sCP-II) is a marker of cartilage synthesis.
Day 1
Time spent in moderate to vigorous physical activity
Time Frame: Day 3-10
Time spent in moderate to vigorous physical activity will be measured using GENEActiv accelerometers worn on the wrist. The devices have previously been validated to quantify physical activity domains.
Day 3-10
Step count
Time Frame: Day 3-10
Step count will be measured using GENEActiv accelerometers.
Day 3-10
Knee joint reaction force
Time Frame: Day 11
Knee joint reaction force will be measured using musculoskeletal modelling in OpenSim. We will use 3D motion capture to measure joint kinematics, an instrumented treadmill to measure ground reaction forces, and electromyography devices to measure muscle activation.
Day 11
Cumulative knee joint reaction force
Time Frame: Days 3-11
We are synchronising data collected by the GENEActiv tri-axial accelerometer with knee joint reaction force during walking and running. We then apply the relationship between these two variables (ascertained during the lab session) to the data collected during the 10 days of wear in free living to provide an estimation of cumulative knee joint reaction force.
Days 3-11
Muscle cross-sectional area
Time Frame: Day 1
We are using peripheral quantitative computerised tomography (pQCT) to measure muscle cross-sectional area. pQCT has previously been validated to measure muscle cross-sectional area.
Day 1
Muscle density
Time Frame: Day 1
We are using peripheral quantitative computerised tomography (pQCT) to measure muscle density. pQCT has previously been validated to measure muscle density.
Day 1
Subcutaneous adipose tissue area
Time Frame: Day 1
We are using peripheral quantitative computerised tomography (pQCT) to measure subcutaneous adipose tissue area. pQCT has previously been validated to measure subcutaneous adipose tissue area.
Day 1
Intra-muscular fat content
Time Frame: Day 1
We are using peripheral quantitative computerised tomography (pQCT) to measure intra-muscular fat content. pQCT has previously been validated to measure intra-muscular fat content.
Day 1
Fat mass index
Time Frame: Day 1
We are using dual-energy x-ray absorptiometry (DEXA) to measure fat mass index. DEXA has previously been validated to measure fat mass index.
Day 1
Lean mass index
Time Frame: Day 1
We are using dual-energy x-ray absorptiometry (DEXA) to measure lean mass index. DEXA has previously been validated to measure lean mass index.
Day 1
Knee Injury and Osteoarthritis Outcome Score
Time Frame: Day 1
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to measure subjective knee joint health. It asks participants to report their symptoms (e.g., pain, stiffness) and function. The KOOS has been validated in a number of populations including those after knee injury.
Day 1
Tampa Scale of Kinesiophobia - 11 score
Time Frame: Day 1
The Tampa Scale of Kinesiophobia - 11 (TSK-11) will be used to measure fear of reinjury/movement. It has been validated in patients with musculoskeletal pain and in knee injury populations.
Day 1
English Knee Self-Efficacy Scale score
Time Frame: Day 1
The English Knee Self-Efficacy Scale (KSES-E) measures knee specific confidence during everyday tasks and physical activity. The KSES-E has been validated in knee injury populations.
Day 1
Modified Godin Leisure Time Exercise Questionnaire score
Time Frame: Day 1
The Modified Godin Leisure Time Exercise Questionnaire (GLTEQ) measures subjective physical activity over a typical seven day period.
Day 1
Time spent in lower body resistance training per week
Time Frame: Day 1
Time spent in lower body resistance training per week will be used to measure subjective time spent in lower body resistance training such as weights or body weight exercise.
Day 1
Serum concentration of chondroitin sulphate 846 epitope
Time Frame: Day 11 and 12
Serum concentration of chondroitin sulphate 846 epitope (sCS846) will be measured as marker of aggrecan synthesis.
Day 11 and 12
Serum concentration of hyaluronic acid
Time Frame: Day 11 and 12
Serum concentration of hyaluronic acid (HA) will be measured as marker of proteoglycan breakdown.
Day 11 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bath

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Versus Arthritis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karl Morgan, MSc, University of Bath

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 304181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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