Impact of Prehabilitation in Total Knee Replacement

NCT ID: NCT01844934

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2016-12-01

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard treatment

The no intervention group will receive standard treatment that includes a four hour class pre-surgery consisting of a description of the surgery, what to expect in the hospital and during recovery and some exercises to be done in preparation for surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Prehabilitation

Prehabilitation:The experimental group will receive a three week prehabilitation program prior to surgery in addition to standard treatment.

Group Type: EXPERIMENTAL

Prehabilitation

Intervention Type: 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.

Interventions

Prehabilitation

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allina Health System

OTHER

Sponsor Role: lead

Responsible Party

Laura Franco

Physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin Crandall, M.D.

Role: PRINCIPAL_INVESTIGATOR

Unity Hospital, Allina Health

Laura Franco, PT, OCS

Role: PRINCIPAL_INVESTIGATOR

Courage Kenny Rehabilitation Institute, Allina Health

Locations

Unity Hospital

Fridley, Minnesota, United States

Countries

United States

Other Identifiers

Study 3963-2 IRB

Identifier Type: -

Identifier Source: org_study_id