Efficacy of Preoperative Muscle Training on Postoperative Orthopaedic Surgery Recovery

NCT03483519 | Completed

• 1 other identifier: 20150684
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge readiness and functional capacity in both the short and long-term. One of the key factors affecting recovery after TJA is how well the patient functions before their surgery. Thus, interventions addressing preoperative function are expected to be beneficial.

Conditions

Arthroplasty; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• HOOS or KOOS Questionnaire to assess self-reported pain

  The Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS). A standardized set of questions to assess the function of the hip or knee (dependent on which surgery the patient is undergoing). The KOOS/HOOS are comprised of 6 sections: 1) Symptoms (3 items), 2) Stiffness (2 items), 3) Pain (10 items), 4) Function Daily Living (17 items), 5) Function/Sports and Recreation (4 items), 6) Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

  12 months

Secondary Outcomes (7)

• Timed-Up-and-Go (TUG)

  12 months

• Timed Stair Test

  12 months

• Length of hospital stay

  1 month

• Post-surgical Complications

  30 days

• Hip or Knee Muscle Strength

  12 months

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Patients in the Prehabilitation Group and are randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care

Other: Rehabilitation

Standard of Care

ACTIVE COMPARATOR

Patients in the Standard of Care will not receive an additional an exercise program, patients will receive the usual care received by all orthopaedic patients.

Other: Standard of Care

Interventions

Rehabilitation OTHER

Patients randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care

Prehabilitation

Standard of Care OTHER

Patients randomized to the Active Comparator Group will not undergo an exercise program, patients will receive the standard of care used at The Ottawa Hospital for hip and knee surgeries. Standard of care protocol will be explained by each individual surgeon.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis;
• WOMAC functional subscale less than 66.5/100.

You may not qualify if:

• Patients under 18 years of age;
• Patients undergoing joint revision on the affected side;
• patients under the same day discharge protocol;
• Patients undergoing bilateral arthroplasty;
• Patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program;
• Patients having surgery in less than 16 weeks after verbal consent;
• Patients unable or unwilling to commit to required study follow-ups;
• Patients with no fixed address;
• Patients with a cognitive impairment that may preclude questionnaire completion;
• Pregnant or suspected pregnant women as dual-energy x-ray (DXA) used in this study may be harmful to a fetus.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (2)

• Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.

  PMID: 20378679 BACKGROUND

• Pacheco-Brousseau L, Dobransky J, Jane A, Beaule PE, Poitras S. Feasibility of a preoperative strengthening exercise program on postoperative function in patients undergoing hip or knee arthroplasty: a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Jul 30;8(1):162. doi: 10.1186/s40814-022-01126-9.

  PMID: 35908037 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Rehabilitation; Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paul Beaule, MD

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: March 30, 2018
• Study Start: December 1, 2016
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

CA (1)