Physical Activity, Knee Joint Loading and Joint Health

NCT ID: NCT05306054

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-07-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Intra-Articular Knee Injury

Forty men and women aged 18-45 years old who are 1-7 years following an intra-articular knee injury.

No interventions assigned to this group

Controls

Forty men and women aged 18-45 years old who are matched to the injured group by age, sex and body mass index.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versus Arthritis

OTHER

Sponsor Role: collaborator

University of Bath

OTHER

Sponsor Role: lead

Responsible Party

Karl Morgan

Chief Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl Morgan, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Bath

Locations

University of Bath

Bath, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Karl Morgan, MSc

Role: CONTACT

kdm40@bath.ac.uk

(0)7853220282 ext. +44

Jean-Philippe Walhin, PhD

Role: CONTACT

jpw23@bath.ac.uk

(0)1225386478 ext. +44

Facility Contacts

Karl Morgan, MSc

Role: primary

kdm40@bath.ac.uk

+44 (0) 1225 38 6399

Other Identifiers

304181

Identifier Type: -

Identifier Source: org_study_id