Clinical trial NCT01844934: Impact of Prehabilitation in Total Knee Replacement
Official title: Impact of Prehabilitation in Total Knee Arthroplasty: Outcomes and Healthcare Service Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Knee Arthroplasty
Knee Replacement
Prehabilitation
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms, one intervention, one control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Secondary outcomes:
measure: Six Minute Walk
timeFrame: Change from baseline to pre-surgery, 4, 14, 26 weeks post-surgery
measure: Gait Speed
timeFrame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
measure: Knee Range of Motion (ROM)
timeFrame: Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgery
measure: Medical Outcomes Study Short Form-36 (SF-36)
timeFrame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
measure: Sit-to-stand repetitions in 30 seconds
timeFrame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
measure: Pain
timeFrame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Other outcomes:
Locations:
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
Study officials:
affiliation: Unity Hospital, Allina Health
name: Robin Crandall, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Courage Kenny Rehabilitation Institute, Allina Health
name: Laura Franco, PT, OCS
role: PRINCIPAL_INVESTIGATOR
References: