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Impact of Prehabilitation in Total Knee Replacement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01844934
Enrollment
43
Registered
2013-05-03
Start date
2014-01-01
Completion date
2016-12-01
Last updated
2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Keywords

Knee Arthroplasty, Knee Replacement, Prehabilitation

Brief summary

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

Detailed description

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.

Interventions

OTHERPrehabilitation

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.

Sponsors

Allina Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

2 arms, one intervention, one control

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgeryWOMAC, 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

MeasureTime frameDescription
Gait SpeedChange from baseline to pre-surgery, 4, 14 and 26 weeks post surgeryGait 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.
Knee Range of Motion (ROM)Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgeryKnee ROM (extension and flexion) will be measured with a goniometer at the surgical joint.
Six Minute WalkChange from baseline to pre-surgery, 4, 14, 26 weeks post-surgeryA valid and reliable measure of total distance walked in six minutes.
Sit-to-stand repetitions in 30 secondsChange from baseline to pre-surgery, 4, 14 and 26 weeks post surgeryNumber of complete stand up to sit down cycles is counted.
PainChange from baseline to pre-surgery, 4, 14 and 26 weeks post surgeryPain 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.
Medical Outcomes Study Short Form-36 (SF-36)Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgeryThe SF-36 measures 8 dimensions of outcome: physical functioning, social functioning, role-physical, bodily pain, mental health, role-emotional, vitality and general health.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026