Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.
NCT ID: NCT06363643
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
44 participants
INTERVENTIONAL
2024-04-22
2024-07-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ELECTROSTIMULATION (ESM)
ESM will perform the Tele Prehab program based on indirect electrostimulation.
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.
EXERCISE (C)
Group C will perform the Tele Prehab program based on supervised exercise.
EXERCISE (C)
C will perform three weekly Tele supervised sessions of exercise. The treatment will last 4 weeks.
Interventions
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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.
EXERCISE (C)
C will perform three weekly Tele supervised sessions of exercise. The treatment will last 4 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
55 Years
80 Years
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Principal Investigators
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Luca Marin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pavia (Italy)
Locations
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"Città di Pavia Healthcare Institute"
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Prehab01
Identifier Type: -
Identifier Source: org_study_id
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