Physical Activity, Knee Joint Loading and Joint Health

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306054
• Other study ID #: 304181
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: University of Bath
• Contact: Karl Morgan, MSc
• Phone: (0)7853220282
• Email: kdm40[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath

Sponsors (2)

Lead Sponsor	Collaborator
University of Bath	Versus Arthritis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 3-10
Secondary	Step count	Step count will be measured using GENEActiv accelerometers.	Day 3-10
Secondary	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.	Day 11
Secondary	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.	Days 3-11
Secondary	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.	Day 1
Secondary	Muscle density	We are using peripheral quantitative computerised tomography (pQCT) to measure muscle density. pQCT has previously been validated to measure muscle density.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	Serum concentration of chondroitin sulphate 846 epitope	Serum concentration of chondroitin sulphate 846 epitope (sCS846) will be measured as marker of aggrecan synthesis.	Day 11 and 12
Secondary	Serum concentration of hyaluronic acid	Serum concentration of hyaluronic acid (HA) will be measured as marker of proteoglycan breakdown.	Day 11 and 12