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Physical Activity, Knee Joint Loading and Joint Health

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05306054
Enrollment
80
Registered
2022-03-31
Start date
2022-06-01
Completion date
2024-07-01
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Post-traumatic Osteoarthritis

Keywords

Physical Activity, Knee Joint Loading, Cumulative Load, Biomarkers, Musculoskeletal Modelling, Patient Reported Outcomes

Brief 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.

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.

Interventions

None listed

Sponsors

Versus Arthritis
CollaboratorOTHER
University of Bath
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Ratio of urine concentration of c-telopeptide of type II collagen to serum concentration of c-propeptide of type II procollagenDay 1Urine 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.

Secondary

MeasureTime frameDescription
Time spent in moderate to vigorous physical activityDay 3-10Time 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.
Step countDay 3-10Step count will be measured using GENEActiv accelerometers.
Urine concentration of c-telopeptide of type II collagenDay 1Urine concentration of c-telopeptide of type II collagen (uCTX-II) is a marker of cartilage degradation.
Knee joint reaction forceDay 11Knee 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.
Cumulative knee joint reaction forceDays 3-11We 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.
Muscle cross-sectional areaDay 1We are using peripheral quantitative computerised tomography (pQCT) to measure muscle cross-sectional area. pQCT has previously been validated to measure muscle cross-sectional area.
Muscle densityDay 1We are using peripheral quantitative computerised tomography (pQCT) to measure muscle density. pQCT has previously been validated to measure muscle density.
Subcutaneous adipose tissue areaDay 1We are using peripheral quantitative computerised tomography (pQCT) to measure subcutaneous adipose tissue area. pQCT has previously been validated to measure subcutaneous adipose tissue area.
Intra-muscular fat contentDay 1We are using peripheral quantitative computerised tomography (pQCT) to measure intra-muscular fat content. pQCT has previously been validated to measure intra-muscular fat content.
Serum concentration of c-propeptide of type II procollagenDay 1Serum concentration of c-propeptide of type II procollagen (sCP-II) is a marker of cartilage synthesis.
Lean mass indexDay 1We are using dual-energy x-ray absorptiometry (DEXA) to measure lean mass index. DEXA has previously been validated to measure lean mass index.
Knee Injury and Osteoarthritis Outcome ScoreDay 1The 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.
Tampa Scale of Kinesiophobia - 11 scoreDay 1The 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.
English Knee Self-Efficacy Scale scoreDay 1The 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.
Modified Godin Leisure Time Exercise Questionnaire scoreDay 1The Modified Godin Leisure Time Exercise Questionnaire (GLTEQ) measures subjective physical activity over a typical seven day period.
Time spent in lower body resistance training per weekDay 1Time 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.
Serum concentration of chondroitin sulphate 846 epitopeDay 11 and 12Serum concentration of chondroitin sulphate 846 epitope (sCS846) will be measured as marker of aggrecan synthesis.
Serum concentration of hyaluronic acidDay 11 and 12Serum concentration of hyaluronic acid (HA) will be measured as marker of proteoglycan breakdown.
Fat mass indexDay 1We are using dual-energy x-ray absorptiometry (DEXA) to measure fat mass index. DEXA has previously been validated to measure fat mass index.

Countries

United Kingdom

Contacts

Primary ContactKarl Morgan, MSc
kdm40@bath.ac.uk(0)7853220282
Backup ContactJean-Philippe Walhin, PhD
jpw23@bath.ac.uk(0)1225386478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026