Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.

Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation. Randomized Controlled Clinical Trial

Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity.

Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteo Arthritis Knee and Hip; Lower Limb Arthroplasty
• Intervention / Treatment: Device: ELECTROSTIMULATION (ES); Other: EXERCISE (C)

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Marin; Phone Number: +39 347 2204734; Email: luca.marin@unipv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • "Città di Pavia Healthcare Institute"
    • Contact: Luca Marin; Phone Number: +39 0382 433658; Email: luca.marin@unipv.it
    • Principal Investigator: Luca Marin
    • Sub-Investigator: Matteo Chiodarono

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective Knee or Total Hip arthroplasty

Exclusion Criteria:

• concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroplasty has been indicated) that modify the ability to walk;
• pathologies that modify the balance (neurological and/or vestibular);
• contraindications to the use of medical equipment used in the study;
• inability to understand and sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ELECTROSTIMULATION (ESM); ESM will perform the Tele Prehab program based on indirect electrostimulation.	Device: ELECTROSTIMULATION (ES); ES will receive the electrostimulator directly at home and will do three weekly Tele supervised sessions of 30 minutes of indirect electrostimulation. The treatment will last 4 weeks.
Active Comparator: EXERCISE (C); Group C will perform the Tele Prehab program based on supervised exercise.	Other: EXERCISE (C); C will perform three weekly Tele supervised sessions of exercise. The treatment will last 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4	30CST is a validated tool to assess strength and endurance of Lower limbs. The patient is seated in a 17" high chair. Count the number of times the patient comes to a full standing position in 30 seconds.	Baseline and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4.	TUG is a validated tool to assess dynamic balance and functional mobility. The patient getting up from a chair from the sitting to the bipedal position, walking three meters, turning, returning, and sitting on the chair again. The variable measured is the total time, in seconds, taken by the test.	Baseline and week 4

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Luca Marin, PhD, University of Pavia (Italy)

Publications and helpful links

General Publications

• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
• Rooks DS, Huang J, Bierbaum BE, Bolus SA, Rubano J, Connolly CE, Alpert S, Iversen MD, Katz JN. Effect of preoperative exercise on measures of functional status in men and women undergoing total hip and knee arthroplasty. Arthritis Rheum. 2006 Oct 15;55(5):700-8. doi: 10.1002/art.22223.
• Coudeyre E, Jardin C, Givron P, Ribinik P, Revel M, Rannou F. Could preoperative rehabilitation modify postoperative outcomes after total hip and knee arthroplasty? Elaboration of French clinical practice guidelines. Ann Readapt Med Phys. 2007 Apr;50(3):189-97. doi: 10.1016/j.annrmp.2007.02.002. Epub 2007 Feb 15.
• Desmeules F, Hall J, Woodhouse LJ. Prehabilitation improves physical function of individuals with severe disability from hip or knee osteoarthritis. Physiother Can. 2013 Spring;65(2):116-24. doi: 10.3138/ptc.2011-60.
• Snow R, Granata J, Ruhil AV, Vogel K, McShane M, Wasielewski R. Associations between preoperative physical therapy and post-acute care utilization patterns and cost in total joint replacement. J Bone Joint Surg Am. 2014 Oct 1;96(19):e165. doi: 10.2106/JBJS.M.01285.
• Talbot LA, Gaines JM, Ling SM, Metter EJ. A home-based protocol of electrical muscle stimulation for quadriceps muscle strength in older adults with osteoarthritis of the knee. J Rheumatol. 2003 Jul;30(7):1571-8.
• Saw MM, Kruger-Jakins T, Edries N, Parker R. Significant improvements in pain after a six-week physiotherapist-led exercise and education intervention, in patients with osteoarthritis awaiting arthroplasty, in South Africa: a randomised controlled trial. BMC Musculoskelet Disord. 2016 May 27;17:236. doi: 10.1186/s12891-016-1088-6.
• Bhave A, Marker DR, Seyler TM, Ulrich SD, Plate JF, Mont MA. Functional problems and treatment solutions after total hip arthroplasty. J Arthroplasty. 2007 Sep;22(6 Suppl 2):116-24. doi: 10.1016/j.arth.2007.04.025. Epub 2007 Jul 26.
• Karimijashni M, Yoo S, Barnes K, Poitras S. Pre- and Post-Operative Rehabilitation Interventions in Patients at Risk of Poor Outcomes Following Knee or Hip Arthroplasty: Protocol for Two Systematic Reviews. Adv Rehabil Sci Pract. 2023 May 10;12:27536351231170956. doi: 10.1177/27536351231170956. eCollection 2023 Jan-Dec.
• De Klerk TC, Dounavi DM, Hamilton DF, Clement ND, Kaliarntas KT. Effects of home-based prehabilitation on pre- and postoperative outcomes following total hip and knee arthroplasty. Bone Jt Open. 2023 May 5;4(5):315-328. doi: 10.1302/2633-1462.45.BJO-2023-0021.
• Walls RJ, McHugh G, O'Gorman DJ, Moyna NM, O'Byrne JM. Effects of preoperative neuromuscular electrical stimulation on quadriceps strength and functional recovery in total knee arthroplasty. A pilot study. BMC Musculoskelet Disord. 2010 Jun 14;11:119. doi: 10.1186/1471-2474-11-119.
• Lyons CL, Robb JB, Irrgang JJ, Fitzgerald GK. Differences in quadriceps femoris muscle torque when using a clinical electrical stimulator versus a portable electrical stimulator. Phys Ther. 2005 Jan;85(1):44-51.
• Jaggers JR, Simpson CD, Frost KL, Quesada PM, Topp RV, Swank AM, Nyland JA. Prehabilitation before knee arthroplasty increases postsurgical function: a case study. J Strength Cond Res. 2007 May;21(2):632-4. doi: 10.1519/R-19465.1.
• Svinoy OE, Bergland A, Risberg MA, Pripp AH, Hilde G. Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway. BMJ Open. 2019 Dec 30;9(12):e031626. doi: 10.1136/bmjopen-2019-031626.

Study record dates

Study Major Dates

• Study Start (Estimated): April 22, 2024
• Primary Completion (Estimated): July 26, 2024
• Study Completion (Estimated): July 26, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Prehab01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The material will be shared as an attachment to the article. All the tools used in the study will be shared.
• IPD Sharing Time Frame: Data will be available when the article is published.
• IPD Sharing Access Criteria: Free access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No