Anterior Cruciate Ligament InjuriesNCT05306054
Physical Activity, Knee Joint Loading and Joint Health
An observational study of Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University of Bath at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2022to 1 Jul 2024
- 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 18-39 years old (i.e., ≥18 and <40 years old)
- Had an anterior cruciate ligament injury and reconstruction 1-7 years ago (i.e., ≥1 and ≤7 years ago)
- Can have sustained damage to meniscus or cartilage, or sustained bone bruising when injured anterior cruciate ligament
- Can participate regardless of the type of reconstruction surgery and if undergone meniscectomy
- Completed anterior cruciate ligament reconstruction rehabilitation and either a surgeon, doctor or physiotherapist has provided clearance to participate in physical activity
- Be able to attend the University of Bath within 2 hours of waking
Who cannot join
- 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)
- Injured the anterior cruciate ligament in both knees (bilateral ACL injury)
- Have/are experiencing a musculoskeletal, cardiovascular, respiratory, immune, metabolic or neurological disease or disorder
- Under 18 or over 39 (i.e., ≥40) years of age
- Body Mass Index ≥40 kg/m²
- Pregnancy
- Positive responses to the Physical Activity Readiness Questionnaire (aside from any involved knee joint issues)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bath
Bath
Karl Morgan, MSc, +44 (0) 1225 38 6399, kdm40@bath.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Post-traumatic Osteoarthritis, Anterior Cruciate Ligament Reconstruction
- Keywords
- Physical Activity, Knee Joint Loading, Cumulative Load, Biomarkers, Musculoskeletal Modelling, Patient Reported Outcomes
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Ratio of urine concentration of c-telopeptide of type II collagen to serum concentration of c-propeptide of type II procollagen
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.
Measured: Day 1
Secondary outcomes (19)
Urine concentration of c-telopeptide of type II collagen
Urine concentration of c-telopeptide of type II collagen (uCTX-II) is a marker of cartilage degradation.
Measured: Day 1
Serum concentration of c-propeptide of type II procollagen
Serum concentration of c-propeptide of type II procollagen (sCP-II) is a marker of cartilage synthesis.
Measured: Day 1
Time spent in moderate to vigorous physical activity
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.
Measured: Day 3-10
Step count
Step count will be measured using GENEActiv accelerometers.
Measured: Day 3-10
Knee joint reaction force
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.
Measured: Day 11
Cumulative knee joint reaction force
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.
Measured: Days 3-11
Muscle cross-sectional area
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.
Measured: Day 1
Muscle density
We are using peripheral quantitative computerised tomography (pQCT) to measure muscle density. pQCT has previously been validated to measure muscle density.
Measured: Day 1
Subcutaneous adipose tissue area
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.
Measured: Day 1
Intra-muscular fat content
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.
Measured: Day 1
Fat mass index
We are using dual-energy x-ray absorptiometry (DEXA) to measure fat mass index. DEXA has previously been validated to measure fat mass index.
Measured: Day 1
Lean mass index
We are using dual-energy x-ray absorptiometry (DEXA) to measure lean mass index. DEXA has previously been validated to measure lean mass index.
Measured: Day 1
Knee Injury and Osteoarthritis Outcome Score
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.
Measured: Day 1
Tampa Scale of Kinesiophobia - 11 score
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.
Measured: Day 1
English Knee Self-Efficacy Scale score
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.
Measured: Day 1
Modified Godin Leisure Time Exercise Questionnaire score
The Modified Godin Leisure Time Exercise Questionnaire (GLTEQ) measures subjective physical activity over a typical seven day period.
Measured: Day 1
Time spent in lower body resistance training per week
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.
Measured: Day 1
Serum concentration of chondroitin sulphate 846 epitope
Serum concentration of chondroitin sulphate 846 epitope (sCS846) will be measured as marker of aggrecan synthesis.
Measured: Day 11 and 12
Serum concentration of hyaluronic acid
Serum concentration of hyaluronic acid (HA) will be measured as marker of proteoglycan breakdown.
Measured: Day 11 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jun 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Versus Arthritis
- Responsible party
- Principal investigator, Karl Morgan, University of Bath
- Investigators
- Karl Morgan, MSc, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306054
- Sponsor's protocol ID
- 304181
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2022
- Last updated
- 15 Mar 2024
- Results posted
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Associations Between Physical Activity, Knee Joint Loading and Joint Health Following Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05306054
- Acronym / sponsor ID
- 304181
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Post-traumatic Osteoarthritis, Anterior Cruciate Ligament Reconstruction
- Keywords
- Physical Activity, Knee Joint Loading, Cumulative Load, Biomarkers, Musculoskeletal Modelling, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Versus Arthritis
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 31 Mar 2022 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 18-39 years old (i.e., ≥18 and <40 years old)
- Had an anterior cruciate ligament injury and reconstruction 1-7 years ago (i.e., ≥1 and ≤7 years ago)
- Can have sustained damage to meniscus or cartilage, or sustained bone bruising when injured anterior cruciate ligament
- Can participate regardless of the type of reconstruction surgery and if undergone meniscectomy
- Completed anterior cruciate ligament reconstruction rehabilitation and either a surgeon, doctor or physiotherapist has provided clearance to participate in physical activity
Key exclusion criteria (7 listed)
- 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)
- Injured the anterior cruciate ligament in both knees (bilateral ACL injury)
- Have/are experiencing a musculoskeletal, cardiovascular, respiratory, immune, metabolic or neurological disease or disorder
- Under 18 or over 39 (i.e., ≥40) years of age
- Body Mass Index ≥40 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
19 secondary outcomes
Urine concentration of c-telopeptide of type II collagen
Time frame: Day 1
Serum concentration of c-propeptide of type II procollagen
Time frame: Day 1
Time spent in moderate to vigorous physical activity
Time frame: Day 3-10
Step count
Time frame: Day 3-10
Knee joint reaction force
Time frame: Day 11
Cumulative knee joint reaction force
Time frame: Days 3-11
Muscle cross-sectional area
Time frame: Day 1
Muscle density
Time frame: Day 1
Subcutaneous adipose tissue area
Time frame: Day 1
Intra-muscular fat content
Time frame: Day 1
Fat mass index
Time frame: Day 1
Lean mass index
Time frame: Day 1
Knee Injury and Osteoarthritis Outcome Score
Time frame: Day 1
Tampa Scale of Kinesiophobia - 11 score
Time frame: Day 1
English Knee Self-Efficacy Scale score
Time frame: Day 1
Modified Godin Leisure Time Exercise Questionnaire score
Time frame: Day 1
Time spent in lower body resistance training per week
Time frame: Day 1
Serum concentration of chondroitin sulphate 846 epitope
Time frame: Day 11 and 12
Serum concentration of hyaluronic acid
Time frame: Day 11 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
Karl Morgan, MSc principal investigator
University of Bath
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 Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University of Bath at 1 site 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Morgan, MSc ((0)7853220282 ext. +44, kdm40@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 15 Mar 2024.