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Completed

NCT Number: NCT01844934

Impact of Prehabilitation in Total Knee Replacement

A study comparing the benefits of pre-habilitation exercise to standard care prior to total knee arthroplasy

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Key information

Conditions

Total Knee Arthroplasty

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unity Hospital

Fridley, Minnesota, 55432, United States

About this study

Recovery post Total Knee Replacement Surgery ((TKA) has been a subject of interest. In a study of 379 patients who had hip or knee replacement surgery, it was reported that at 6 months post-surgery patients with better baseline function had superior functional ability and less pain than patients with lower function at baseline. Another study of 276 patients undergoing TKA reported that pre-operative joint function was a predictor of joint function and overall function at 6 months post-surgery. These findings suggest that prehabilitation to increase functional ability prior to TKA may have a positive effect in recovering post-surgery. In a randomized control trial of patients receiving TKA, the group receiving an Exercise Program (prehabilitation) made significant improvements in performance from baseline to before surgery, and at 1 and 3 months post surgery. For the group that did not receive the Exercise Program pre-surgery, significant improvement did not occur until 3 months post surgery. The overall objective of the proposed single-blinded randomized controlled trial is to demonstrate that a well designed prehabilitation program for patients receiving TKA surgery will significantly improve outcomes related to pain and function and may reduce utilization of health care services post surgery.

In this randomized control trial we hypothesize that the group of participants who receive a prehabilitation Exercise Program will recover quicker than patients who do not receive the Exercise Program based on several measures of performance including pain, quadriceps strength, range of motion and quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo unilateral TKA surgery
  • Ambulatory
  • Community dwelling (living at home)
  • Able to participate in moderate intensity exercise
  • American Society of Anesthesiologists Physical Status Classification(ASA) 1 - 3
  • Speaks English

Exclusion criteria

  • Patients who are planning a second surgery of the lower limbs during the six months post-surgery
  • Have the effect of peripheral vascular disease or stroke on walking

Treatment and study plan

Prehabilitation

Other

The three week, 3 days / week prehabilitation exercise program will consist of resistance training, step training and stretching(flexibility) as well as cardiovascular endurance training. Intensity of training will increase over the three weeks. Classes will be delivered over a four week period with a gap during the third week allowing additional time for participants to practice their exercises. The home exercise program will be designed to account for the additional week.

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

    WOMAC, a self-assessment tool, is a valid and reliable instrument developed specifically to measure outcomes related to interventions for treatment of the hip and knee. Consisting of three domains: physical, pain and stiffness; a total score is derived by aggregating the domain scores.

Secondary outcomes

  1. Six Minute Walk

    Time frame: Change from baseline to pre-surgery, 4, 14, 26 weeks post-surgery

    A valid and reliable measure of total distance walked in six minutes.

  2. Gait Speed

    Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

    Gait speed will be measured with the 10 meter walk. It will be assessed under two conditions: 1) instructed to walk at normal speed, 2) instructed to walk as fast as possible.

  3. Knee Range of Motion (ROM)

    Time frame: Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgery

    Knee ROM (extension and flexion) will be measured with a goniometer at the surgical joint.

  4. Medical Outcomes Study Short Form-36 (SF-36)

    Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

    The SF-36 measures 8 dimensions of outcome: physical functioning, social functioning, role-physical, bodily pain, mental health, role-emotional, vitality and general health.

  5. Sit-to-stand repetitions in 30 seconds

    Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

    Number of complete stand up to sit down cycles is counted.

  6. Pain

    Time frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

    Pain will be measured upon completion of each of the functional tasks (gait speed, six-minute walk and sit to stand) using a Visual Analog Scale from 0 to 10 where 0 is no pain and 10 is severe pain.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Official study title

Impact of Prehabilitation in Total Knee Arthroplasty: Outcomes and Healthcare Service Utilization

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 3, 2013
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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