Physical Activity, Knee Joint Loading and Joint Health

NCT05306054 | Recruiting

• 1 other identifier: 304181
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Urine concentration of c-telopeptide of type II collagen

  Day 1

• Serum concentration of c-propeptide of type II procollagen

  Day 1

• Time spent in moderate to vigorous physical activity

  Day 3-10

• Step count

  Day 3-10

• Knee joint reaction force

  Day 11

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bath: lead
• Versus Arthritis: collaborator

Study Sites (1)

University of Bath

Bath, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Serum and Plasma. Urine.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Behavior

Study Officials

• Karl Morgan, MSc

  University of Bath

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl Morgan, MSc

CONTACT

(0)7853220282; kdm40@bath.ac.uk

Jean-Philippe Walhin, PhD

CONTACT

(0)1225386478; jpw23@bath.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)