Preoperative Rehabilitation Training and Total Knee Arthroplasty Outcomes

NCT06983912 | Not Yet Recruiting

• 1 other identifier: FuzhouAffiliated
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Joint replacement surgery is an effective treatment for severe joint diseases, but the postoperative recovery process is complex and lengthy. Preoperative rehabilitation training, as an important part of preoperative preparation, has been proven to significantly improve postoperative recovery outcomes. However, there is currently a lack of systematic research on the optimal protocols and duration of preoperative rehabilitation training and their specific impacts on postoperative recovery. This study aims to evaluate the effects of preoperative rehabilitation training on postoperative recovery after joint replacement through a randomized controlled trial, providing scientific evidence for clinical practice.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Knee Joint Function Assessment

  Knee injury and Osteoarthritis Outcome Score (KOSS): KOOS is a scale used to assess symptoms and function in patients with knee injury and osteoarthritis, widely applied in clinical practice and research. It includes five dimensions (pain, other symptoms, function in daily living, function in sport and recreation, quality of life), with each dimension comprising several questions that patients rate based on their personal conditions. The scoring range for each question is 0-10 points, where 0 indicates no symptoms or difficulty, and 10 indicates the most severe symptoms or difficulties. The total score for each dimension is the average of all the questions within that dimension, ranging from 0 to 100 points. The higher the score, the milder the symptoms and the better the function.

  Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery

Secondary Outcomes (1)

• Postoperative Assessment

  Following total knee arthroplasty, assessments are typically conducted at the 1st, 3rd, 6th, and 12th month post-surgery.

Study Arms (2)

No intervention

NO INTERVENTION

Preoperative Rehabilitation Training

EXPERIMENTAL

Behavioral: Preoperative Rehabilitation Training

Interventions

Preoperative Rehabilitation Training BEHAVIORAL

Initiate preoperative Physical Rehabilitation Training (PRT) starting from the preoperative period, with training five days a week up until the day before surgery. This includes: Muscle Strength Training: Isometric contractions of the quadriceps, straight leg raises, etc., for 15-20 minutes per session, twice daily. Joint Mobility Training: Flexion and extension exercises of the knee joint, ankle pump exercises, etc., for 10-15 minutes per session, twice daily. Balance Training: One-legged standing, center of gravity shifting exercises, etc., for 10-15 minutes per session, twice daily. Activities of Daily Living Training: Transfer training from sitting to standing, walking exercises, etc., for 10-15 minutes per session, twice daily.

Preoperative Rehabilitation Training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis is osteoarthritis and Scheduled for joint replacement surgery.
• Age ≥18 years old and ≤90 years old, with no gender restrictions.
• Patients voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• Severe cardiopulmonary insufficiency, unable to tolerate rehabilitation training.
• Neurological disorders leading to motor dysfunction.
• Mental illnesses that prevent cooperation with rehabilitation training.
• Severe joint deformities or muscle atrophy present before surgery, affecting the implementation of rehabilitation training.

Sponsors & Collaborators

• Fuzhou University Affiliated Provincial Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Haiqi Ding

CONTACT

0591-88217200; dhq9119@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 21, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-04