Exercise and Cycle Ergometry Post TKA - A Randomized Controlled Trial

NCT02265523 | Completed

• 1 other identifier: NOAMA - Sanzo2014
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to examine the effect of, and improve patient compliance and motivation following total knee arthroplasty; to determine the efficacy of two post-surgical exercise programs on knee pain, function, range of motion, strength, and swelling (girth); and to establish a panel of biomarkers that will allow: a) early identification of patients at risk (i.e. unable to complete post-operative treatment) and; b) predict the likelihood of a successful treatment outcome post-surgically.

Conditions

Osteoarthritis; Deep Venous Thrombosis

Keywords

Arthroplasties, Replacement, Knee

Outcome Measures

Primary Outcomes (2)

• Knee pain/functional status/swelling/ROM/strength

  Knee pain will be measured using the visual analog scale (VAS), and functional status will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Knee swelling will be measured via girth measures taken 15 cm superior to the superior pole of the patella; at the supra and infrapatellar regions; and 15 cm inferior to the inferior pole of patella, and flexion and extension ROM will be measured in degrees using a goniometer. The mean of three trials of resisted isometric knee flexor and extensor strength will be measured in lbs of force using a Lafayette Manual Muscle Tester.

  All will be measured pre-operatively (baseline measure), and at day 2 post-operatively, upon discharge (anywhere from day 5-14 post-operatively), and 12 weeks post-operatively to observe changes from the baseline measure.

• Blood markers of inflammation/nutritional status/thrombogenesis risk

  Plasma and serum will be isolated from whole blood samples and various assays will be completed to detect markers indicative of inflammation, poor nutritional status, and increased risk of thromboembolic events.

  All will be measured pre-operatively (baseline measure), at day 2 post-operatively, and upon discharge (anywhere from day 5-14 post-operatively) to observe changes from the baseline measure.

Secondary Outcomes (2)

• Participant motivation.

  Questionnaire will be completed pre-operatively, at day 2 post-operatively, upon discharge (anywhere from 5-14 days post-operatively), and 12 weeks post-operatively.

• Patient compliance.

  Questionnaire will be completed pre-operatively, at day 2 post-operatively, upon discharge (anywhere from 5-14 days post-operatively), and 12 weeks post-operatively.

Other Outcomes (1)

• Adverse events.

  Will be completed from pre-operative to 12 weeks post-operatively as they arise.

Study Arms (2)

Standard Post-op Exercise Group

NO INTERVENTION

The standard post-operative exercises are already currently recommended to patients. Briefly, they include deep breathing and coughing, ankle pumping, buttock contractions, and static quadriceps strengthening. These are performed on a daily basis , 2-3 times per day, 30 repetitions.

Viscus Group

EXPERIMENTAL

The Viscus (intervention) group will complete the standard post-operative exercises and will also have access to a Viscus V1.5 cycle ergometer 24 hours per day in their recovery room to use at their leisure.

Other: Cycle ergometer

Interventions

Cycle ergometer OTHER

The Viscus V1.5 is a kinetic flywheel cycle ergometer that will allow participants' pedal revolutions to be tracked as well as time of use.

Viscus Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 50-80 years awaiting unilateral total knee arthroplasties
• Willing to provide informed consent
• Willing to be randomized to either of the post-operative treatment pathways and willing to follow the study protocol

You may not qualify if:

• Serious cardiac, renal, hepatic, neoplastic and psychiatric diseases
• Diabetes
• Abnormal thyroid and adrenal function.

Sponsors & Collaborators

• Lakehead University: lead
• Northern Ontario School of Medicine: collaborator

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B 5E1, Canada

Location

Related Publications (1)

• Sanzo P, Niccoli S, Droll K, Puskas D, Cullinan C, Lees SJ. The effects of exercise and active assisted cycle ergometry in post-operative total knee arthroplasty patients - a randomized controlled trial. J Exp Orthop. 2021 Jun 22;8(1):41. doi: 10.1186/s40634-021-00363-w.

  PMID: 34159469 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Venous Thrombosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Paolo Sanzo

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 16, 2014
• Study Start: January 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

CA (1)