Clinical trial NCT05306054: Physical Activity, Knee Joint Loading and Joint Health
Official title: Investigating the Associations Between Physical Activity, Knee Joint Loading and Joint Health Following Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: Versus Arthritis
First posted: 2022-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Ratio of urine concentration of c-telopeptide of type II collagen to serum concentration of c-propeptide of type II procollagen
timeFrame: Day 1
Secondary outcomes:
measure: Urine concentration of c-telopeptide of type II collagen
timeFrame: Day 1
measure: Serum concentration of c-propeptide of type II procollagen
timeFrame: Day 1
measure: Time spent in moderate to vigorous physical activity
timeFrame: Day 3-10
measure: Step count
timeFrame: Day 3-10
measure: Knee joint reaction force
timeFrame: Day 11
measure: Cumulative knee joint reaction force
timeFrame: Days 3-11
measure: Muscle cross-sectional area
timeFrame: Day 1
measure: Muscle density
timeFrame: Day 1
measure: Subcutaneous adipose tissue area
timeFrame: Day 1
measure: Intra-muscular fat content
timeFrame: Day 1
measure: Fat mass index
timeFrame: Day 1
measure: Lean mass index
timeFrame: Day 1
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Day 1
measure: Tampa Scale of Kinesiophobia - 11 score
timeFrame: Day 1
measure: English Knee Self-Efficacy Scale score
timeFrame: Day 1
measure: Modified Godin Leisure Time Exercise Questionnaire score
timeFrame: Day 1
measure: Time spent in lower body resistance training per week
timeFrame: Day 1
measure: Serum concentration of chondroitin sulphate 846 epitope
timeFrame: Day 11 and 12
measure: Serum concentration of hyaluronic acid
timeFrame: Day 11 and 12
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
affiliation: University of Bath
name: Karl Morgan, MSc
role: PRINCIPAL_INVESTIGATOR
References: