Impact of Prehabilitation in Total Knee Replacement

NCT01844934 | Completed

• 1 other identifier: Study 3963-2 IRB
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Total Knee Arthroplasty

Keywords

Knee Arthroplasty; Knee Replacement; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  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.

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

Secondary Outcomes (6)

• Six Minute Walk

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

• Gait Speed

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

• Knee Range of Motion (ROM)

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

• Medical Outcomes Study Short Form-36 (SF-36)

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

• Sit-to-stand repetitions in 30 seconds

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

Study Arms (2)

Standard treatment

NO INTERVENTION

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.

Prehabilitation

EXPERIMENTAL

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

Other: Prehabilitation

Interventions

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.

Prehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robin Crandall, M.D.

  Unity Hospital, Allina Health

  PRINCIPAL INVESTIGATOR

• Laura Franco, PT, OCS

  Courage Kenny Rehabilitation Institute, Allina Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: 2 arms, one intervention, one control

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)