Status:
COMPLETED
Exercise Program After Total Hip and Knee Replacement: a Randomized Controlled Trial
Lead Sponsor:
Istituto Ortopedico Rizzoli
Collaborating Sponsors:
University of Bologna
Conditions:
Improve Quality of Life
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
Randomized controlled trial. Patients will be enrolled at the moment of the pre-surgery assessment after verifying the inclusion/exclusion criteria and signing written informed consent. After surgical...
Detailed Description
The present study is carried out within the project "Physical ActIvity after hip and knee Replacement" (PAIR) and funded within the Erasmus Plus Sport program (Grant Agreement 613008-EPP-1-2019-1-IT-S...
Eligibility Criteria
Inclusion
- Pre-surgery criteria
- Signed informed consent
- Age: 50-80 years
- Indications: Patient with unilateral advanced Osteo-Arthrosis (OA) requiring primary THR or TKR;
- General: American Society of Anesthesiologists (ASA) class 1 or 2
- Resident in Bologna metropolitan area
- Post-surgery criteria
- Functional performance: Able to stand and walk \>500 meters independently;
- Pain: score ≤ 4 in VAS
Exclusion
- Unable/unwilling to sign the informed consent form of the study and/or willing to comply with the study requests
- Poor knowledge of Italian language which prevents understanding of the content of the consent form and/or of instructions for assessment and/or training;
- Severe functional limitations of other lower extremity joints besides that for which surgery is planned;
- Impairment of communicative and/or sensory functions so severe to make impossible understanding or executing trainer's instructions (dementia, aphasia, blindness, deafness);
- Heart failure (NYHA class \>2);
- Unstable angina;
- Pulmonary disease requiring oxygen therapy;
- Symptomatic peripheral arteriopathy;
- Recent myocardial infarction or hospital admission for any other reason in the previous 6 months;
- Symptomatic orthostatic hypotension;
- Hypertension in poor pharmacologic control (diastolic \>95 mmHg, systolic \>160 mmHg);
- Relevant neurological condition impairing motor or cognitive function;
- Any other condition that the medical doctor (MD) considers to contraindicate the participation in an exercise program of moderate intensity;
- Severe depression.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04761367
Start Date
January 1 2021
End Date
December 31 2023
Last Update
September 23 2024
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136