The Effect of Therapeutic Exercise on Cartilage Morphology and Physical Function for Individuals at High Risk of Knee Osteoarthritis

NCT06532851 | Recruiting

• 1 other identifier: 20230630
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial aims to evaluate the efficacy of progressive resistance exercises (PRE) versus aerobic exercises on cartilage morphology and physical function in patients with degenerative meniscus tears. 54 participants, aged 35-55, will be randomly assigned to one of three groups: PRE, aerobic exercise, or control (standard of care physical and medical therapy). The study will utilize MRI T2 mapping to assess changes in cartilage composition and patient-reported and performance-based measures to evaluate clinical outcomes. This pilot study will also determine the feasibility and issues related to recruitment and retention for a larger trial.

Conditions

Meniscus Tear

Keywords

Degenerative Meniscus Tear; MRI T2 Mapping; Progressive Resistance Exercise; Aerobic Exercise; Knee Pain; Cartilage Morphology; Exercise Therapy; Early Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Short echo T2*

  Short echo time T2\* imaging is used to diagnose early cartilage degeneration. T2\* measures the rate at which the MRI signal decays, particularly focusing on short-T2 signals (less than 10 milliseconds) which decay rapidly (3-6).

  Baseline, 3-month, 12-month, and 5 years follow-ups.

Secondary Outcomes (8)

• Single leg hop test for a distance

  Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.

• Single Leg Squat Test

  Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.

• The Timed Stair Climbing Test (SCT)

  Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.

• The Single Leg Chair Rise (SLCR) test

  Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.

• Maximal voluntary isometric contraction test

  Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.

Study Arms (3)

Progressive Resistance Exercise (PRE)

EXPERIMENTAL

Participants will perform progressive resistance exercises focusing on strengthening the quadriceps muscles. The exercises will be adjusted based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique.

Other: Progressive Resistance Exercise (PRE)

Aerobic Exercise

EXPERIMENTAL

Participants will engage in aerobic exercise sessions using a stationary bike, aimed at improving cardiovascular fitness and knee joint mobility.

Other: Aerobic Exercise

Control

ACTIVE COMPARATOR

Participants will receive standard of care, including general strength and balance exercises as per current clinical guidelines.

Other: Control

Interventions

Progressive Resistance Exercise (PRE) OTHER

A structured exercise regimen focusing on increasing muscular strength and endurance through progressive resistance.

Also known as: Exercise Therapy, Resistance Training

Progressive Resistance Exercise (PRE)

Aerobic Exercise OTHER

An exercise program focusing on cardiovascular conditioning using a stationary bike.

Also known as: Exercise Therapy, Aerobic Training

Aerobic Exercise

Control OTHER

A set of general strength and balance exercises that do not target the specific therapeutic goals of the other interventions.

Also known as: Comparator

Control

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are between 35 and 55 years of age.
• Have a symptomatic degenerative medial meniscus tear as evidenced by:
• Presence of medial knee pain.
• Medial joint line tenderness.
• Pain and limited motion when attempting to perform a full squat and
• Increased intra-meniscal signal on at least 2 consecutive MRI slices and
• Have clearance from their personal physician to participate in an exercise program.

You may not qualify if:

• Radiographic evidence of OA (K-L grade 2 or above).
• A repairable meniscus injury (longitudinal tear in the outer 1/3 of the meniscus).
• A meniscus injury that requires meniscectomy (locked knee).
• Prior or current ligament injury or surgery of the involved knee.
• Prior or current injury or surgery to contra-lateral knee.
• Pathological ligamentous laxity upon examination of the knee
• An inflammatory arthritic condition or
• Any injury or condition involving the lower extremities that affects their ability to walk.
• Because participation in this study requires undergoing MRI, subjects will be excluded if they:
• If female, pregnant at the time of enrollment.
• Had prior surgery for an aneurysm; any medical illness that may interfere with the patient's general fitness or exercise capability.
• Had any contraindication with MRI.
• Had surgery within the past two months.
• Have a cardiac pacemaker.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (2)

King Abdullah University Hospital

Ar Ramtha, Jordan

RECRUITING

Jordan University of Science and Technology

Irbid, Jordan

RECRUITING

Related Links

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy; Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, the outcomes assessor and the investigators will be blinded to the group allocation. The outcomes assessor will be unaware of the participants' group assignments to minimize the potential bias in evaluating outcomes. Similarly, the treatment assignment will only be displayed to the principal investigator once it has been determined that the subject meets all eligibility criteria, thus preserving concealed allocation of the randomization assignment from the study investigators and the individuals responsible for subject recruitment and follow-up. To minimize bias throughout the study, individuals responsible for collecting the outcome measures will remain blinded to group assignment for the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this model, participants are assigned to one of the three groups (PRE, aerobic exercise, control) and remain in that group for the duration of the study. Each group receives a different intervention, allowing for direct comparisons between the interventions.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

JO (2)