Osteo Arthritis Knee and HipNCT06363643
Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.
A study testing ELECTROSTIMULATION (ES) and EXERCISE (C) in people with Osteo Arthritis Knee and Hip and Lower Limb Arthroplasty, run by University of Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee and Hip, Lower Limb Arthroplasty
- What is being tested?
- ELECTROSTIMULATION (ES) and EXERCISE (C)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2024to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Knee or Total Hip arthroplasty
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
"Città di Pavia Healthcare Institute"
Pavia, 27100
Luca Marin, 0382 433658 ext. +39, luca.marin@unipv.it
Luca Marin
About this study
Official title: 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.
- Being tested
- ELECTROSTIMULATION (ES), EXERCISE (C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELECTROSTIMULATION (ES)Device
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)Other
C will perform three weekly Tele supervised sessions of exercise. The treatment will last 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ELECTROSTIMULATION (ESM) | Experimental | ESM will perform the Tele Prehab program based on indirect electrostimulation. Receives: Device: ELECTROSTIMULATION (ES) |
| EXERCISE (C) | Active comparator | Group C will perform the Tele Prehab program based on supervised exercise. Receives: Other: EXERCISE (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4
Secondary outcomes (1)
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.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start22 Apr 2024 (estimated)
- Primary completion26 Jul 2024 (estimated)
- Study completion26 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis Knee and HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Marin, PhD, Principal investigator, University of Pavia (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363643
- Sponsor's protocol ID
- Prehab01
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The material will be shared as an attachment to the article. All the tools used in the study will be shared.
Publications
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.
PubMed 17823029Coudeyre 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.
PubMed 17343953Rooks 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.
PubMed 17013852Snow 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.
PubMed 25274793Desmeules 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.
PubMed 24403671Saw 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.
PubMed 27233479Karimijashni 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.
PubMed 37188054De 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.
PubMed 37142259Walls 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.
PubMed 20540807Talbot 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.
PubMed 12858461Lyons 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.
PubMed 15623361Jaggers 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.
PubMed 17530958Svinoy 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.
PubMed 31892650World 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.
PubMed 24141714Patane P, Pellino VC, Manzoni F, Caldarella E, Febbi M, Pedrotti L, Vandoni M, Gatti A, de Caro F, Marin L. Effectiveness of three remote tele-prehabilitation strategies in patients awaiting lower limb arthroplasty: a three-arm randomized controlled trial. BMC Musculoskelet Disord. 2026 Jul 25;27(1):896. doi: 10.1186/s12891-026-10281-6.
PubMed 42902309
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06363643
- Acronym / sponsor ID
- Prehab01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 26 Jul 2024 (estimated)
- Study completion
- 26 Jul 2024 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELECTROSTIMULATION (ESM) | Experimental | Device: ELECTROSTIMULATION (ES)ESM will perform the Tele Prehab program based on indirect electrostimulation. |
| EXERCISE (C) | Active comparator | Other: EXERCISE (C)Group C will perform the Tele Prehab program based on supervised exercise. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective Knee or Total Hip arthroplasty
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ELECTROSTIMULATION (ESM) |
| EXERCISE (C)C will perform three weekly Tele supervised sessions of exercise. The treatment will last 4 weeks. | Other | EXERCISE (C) |
Primary outcome
Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4
Time frame: Baseline and 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.
1 secondary outcome
Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4.
Time frame: Baseline and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 17823029Bhave 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.
- Background: PubMed 17343953Coudeyre 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.
- Background: PubMed 17013852Rooks 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.
- Background: PubMed 25274793Snow 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.
- Background: PubMed 24403671Desmeules 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.
- Background: PubMed 27233479Saw 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.
- Background: PubMed 37188054Karimijashni 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.
- Background: PubMed 37142259De 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.
- Background: PubMed 20540807Walls 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.
- Background: PubMed 12858461Talbot 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.
- Background: PubMed 15623361Lyons 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.
- Background: PubMed 17530958Jaggers 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.
- Individual participant dataSharing planned: Yes. The material will be shared as an attachment to the article. All the tools used in the study will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Marin, PhD principal investigator
University of Pavia (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELECTROSTIMULATION (ES) and EXERCISE (C) in people with Osteo Arthritis Knee and Hip and Lower Limb Arthroplasty, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Marin (347 2204734 ext. +39, luca.marin@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4 (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06363643, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.