Exercise Program After Total Hip and Knee Replacement: a Randomized Controlled Trial

NCT04761367 | Completed

• 1 other identifier: 1005/2020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 treatment (THR or TKR) and subsequent rehabilitation treatment (which usually lasts 3-4 months) patients will be contacted and the persistence of inclusion/exclusion criteria verified again. For each type of surgical procedure (i.e. THR or TKR) those, with confirmed inclusion criteria will be randomly assigned to the IG or the CG. The IG will participate in a 6-month exercise program based on the PAIR exercise protocol and will receive educational sessions and material on the importance of maintaining an active life style after THR or TKR. The CG will receive only educational sessions and material on the importance of maintaining an active life style after THR or TKR. Participants of both IG and CG will be assessed at the moment of randomization (post-surgery baseline) and, subsequently, after 3 and 6 months.

Conditions

Improve Quality of Life

Keywords

total knee replacement; total hip replacement; Physical activity; total knee prosthesis; total hip prosthesis

Outcome Measures

Primary Outcomes (1)

• Quality of life questionnaire

  Short-Form Health Survey (SF-36). SF-36 is one of the most widely used questionnaire to measure the health related quality of life (QoL) items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100

  6 months

Secondary Outcomes (12)

• Clinical score about Hip

  6 months

• Clinical Score about Hip

  6 months

• Pain score

  6 months

• Lower limb function

  6 months

• Disability

  6 months

Study Arms (2)

INTERVENTION GROUP

OTHER

The IG will participate in a 6-month exercise program based on the PAIR exercise protocol and will receive educational sessions and material on the importance of maintaining an active life style after THR or TKR

Other: Physical activity. Physical Activity program is performed in a group in a gym

CONTROL GROUP

NO INTERVENTION

The CG will receive only educational sessions and material on the importance of maintaining an active life style after THR or TKR

Interventions

Physical activity. Physical Activity program is performed in a group in a gym OTHER

The intervention groups will be trained in a gyms under the direct supervision of a graduate trainer. All subjects will be requested to choose an additional third day of the week to carry out at least one of the following activities: walking, cycling or swimming

INTERVENTION 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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• University of Bologna: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• D Dallari, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 18, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)