Preoperative Rehabilitation in Greek Patients Undergoing Total Knee Arthroplasty

NCT04911205 | Completed

• 1 other identifier: 1819019724
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: The purpose of this study was to investigate the efficacy of a 6-week supervised high-intensity preoperative training program on muscle strength, functional performance and patient-reported outcomes in patients undergoing total knee arthroplasty (TKA). Methods: Eighty-eight patients scheduled for unilateral TKA for severe osteoarthritis (OA) were randomly allocated to intervention group (N=44) completed a 6-week preoperative training program, 5 days per week prior to surgery and to control group (N=44) who lived as usual. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Physical Functioning Scale of the Short Form-36 questionnaire (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS), quadriceps strength, 20 meters walk test and 30 seconds chair stand test were assessed at 6 weeks before surgery (T0), after 6 weeks of preoperative training / preoperatively (T1), 4 weeks (T2) and finally 12 weeks (T3) after TKA.

Conditions

Knee Osteoarthritis; Rehabilitation

Keywords

physiotherapy; preoperative rehabilitation; osteoarthritis; total knee replacement

Outcome Measures

Primary Outcomes (4)

• Change of Quadriceps strength

  All patients performed 3 maximal isometric contractions of the knee extensors at a knee joint angle of 700 (00 = full knee extension) and of the knee flexors at a knee joint angle of 200 with 60 seconds rest in between (Knapik et al., 1983). For further analysis we selected the attempt with the highest peak torque (Nm). The patients performed 6 maximal concentric contractions in full possible range of motion (ROM); the attempt with the highest peak torque was selected for further analysis. Peak torque values were normalized to body weight and reported as Nm/kg

  Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty

• Knee pain

  the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) score was applied in the Greek-language version. All patients completed the questionnaire 6 weeks before the surgical procedure, 2-3 days before TKA and 4 and12 weeks postoperatively. The WOMAC is a disease-specific, self-administered questionnaire developed to study patients with hip or knee OA and requires about 10-12 minutes to complete. It has a multidimensional scale made up of 24 items grouped into three dimensions: pain (five items), stiffness (two items), and physical function (17 items). The test questions are scored on a scale of 0-4 and the scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function.

  Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty

• Daily living activities

  The SF-36 is a valid and reliable instrument for assessing the general health and function of undergoing TKA patients and is a core component of suggested outcome measures for this procedure. The scores of each subscale are normalized to a scale ranging from 0 to 100, with a higher score reflecting a better health status. We used the Greek version of SF-36 Health Survey and we evaluate physical functioning. Knee injury and Osteoarthritis Outcome Score (KOOS) is a useful scale in evaluating symptoms and functional status related to knee injury and knee OA. This tool has five subscales, namely pain, symptoms, daily living, sports and recreational activities, and quality of life related to the knee. KOOS has high test-retest reliability.

  Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty

• Knee joint function

  The 20-meter walk test is frequently used in clinical trials and cohort studies involving individuals with OA, as well as in physical therapy. We measured the 20-meter walk course with a measure wheel and we measured how many seconds each patients neede to complete this distance. The investigator stopped timing as soon as the participant's first heel completely crossed the strip of tape. Studies reported that the 20-meter walk test has a high test-re-test reliability among patients with end-stage OA awaiting knee replacements Additionally, we used the 30-second chair stand test that involves recording the number of stands a person can complete in 30 seconds. The participant is seated back straight in the middle of a chair without arms (seat height 45 cm).The participant is instructed to fully sit between each stand and encouraged to complete as many full stands as possible within 30 seconds.

  Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients who were randomly allocated to intervention group (N=44) completed a 6-week preoperative training program, 5 days per week prior to surgery

Other: Preoperative training program

Control Group

NO INTERVENTION

Patients who were randomly allocated to control group (N=44), they continued to live as usual, prior to surgery

Interventions

Preoperative training program OTHER

Patients of intervention group (N=44) followed a 6-week supervised high-intensity preoperative training program. They had a session of preoperative resistance training five days per week for a period of 6 weeks before TKA. Each session was supervised by a physiotherapist specifically trained in progressive resistance training. The duration of each session was approximately 60 minutes. If a participant missed a training session, it was attempted to substitute the session on an alternative day.

Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• Patients were diagnosed with advanced idiopathic knee OA (according to the radiological criteria of the American College of Rheumatology Guidelines)
• Patients who were scheduled for unilateral total knee arthroplasty in Orthopedic Clinic of University Hospital of Alexandroupolis

You may not qualify if:

• \) Medical conditions that exercise was contraindicated (i.e cardiopulmonary comorbidities that precluded modest exercise 2) Diseases that affected their functional performance (suffering from neuromuscular or neurodegenerative conditions) 3) Mental diseases 4) Previous hip or knee joint replacement surgery 5) Severe pain on the controlateral limp that would not allow them to follow any pre- or postoperative interventions

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Mr Dimitrios Vasileiadis

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 2, 2021
• Study Start: March 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2019
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share