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

Efficacy and Safety of PAIR Exercise Program After Total Hip and Knee Replacement: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Improve Quality of Life
• Intervention / Treatment: Other: Physical activity. Physical Activity program is performed in a group in a gym

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-SPO-SCP). It is aimed at evaluating the efficacy and safety of an exercise program specifically designed for improving physical function and QoL in people who had undergone THR or TKR for primary osteoarthritis after completing the surgical and rehabilitative treatment.

The primary objective of the study is to compare modifications of QoL measured with the Short-Form Health Survey (SF-36) induced in the intervention groups (IG) by the PAIR exercise program versus a control groups (CG) who will undergo usual care. SF-36 is one of the most widely used questionnaire to measure the health related QoL (HRQoL) in total hip and total knee arthroplasty patients.

The secondary objectives of the study are to investigate differences between IG and CG on domains which are considered to be determinants of QoL:

Hip- and knee-related impairments and functional limitations

• Harris Hip Score (HHS), American Knee Society scoring (KSS),
• Visual analog scale (VAS) to evaluate pain, High-Activity Arthroplasty Score (HAAS), ---Western Ontario and McMasters Universities Osteoarthritis
• Index (WOMAC),
• Knee Injury and Osteoarthritis Outcome Score (KOOS)
• Hip Disability and Osteoarthritis Score (HOOS).

Hip- and knee-related functional status

• Time Up and GO (TUG),
• Single Stance test,
• The 30-second Chair-Stand Test (30s-CST),
• Hand Grip test, Maximal strength of the lower limb,
• Hip and knee joints mobility (by goniometry).

Life style The ultimate goal of the PAIR exercise program is to increase physical activity in a sedentary population. The exercise program, through its beneficial effects on health, is expected to generate a virtuous circle promoting a more active life-style. For this domain 2 instruments will be used: Recent Physical Activity Questionnaire (RPAQ) and PAIR questionnaire for patients' attitudes toward physical (instrument generated within the PAIR project).

Safety: Adverse clinical events (ACEs) occurred to the participants both inside and outside gym classes.

Adherence: adherence of each subjects to the exercise program will be monitored in the IG. The adherence will be measured as percent of exercise sessions actually performed/total number of scheduled exercise sessions. Other factors considered to influence the adherence to an exercise program will be also recorded (age, gender, comorbidity, BMI, educational level, marital status, working activity, and home gym-distance).

Participants' satisfaction Satisfaction of PAIR exercise program is a very important domain since influence adherence. It will be verified by asking few questions with structured responses based on a 7-point Likert scale, to get participants' opinion about the PAIR exercise program.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura LB Bragonzoni, RDT B; Phone Number: +390516366516; Email: laura.bragonzoni4@unibo.it
• Study Contact Backup: Name: Dante Dallari; Phone Number: +39051-6366318; Email: dante.dallari@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Laura Bragonzoni, Phd; Phone Number: +0390516366516; Email: laura.bragonzoni4@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: INTERVENTION GROUP; 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; 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
No Intervention: CONTROL GROUP; The CG will receive only educational sessions and material on the importance of maintaining an active life style after THR or TKR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical score about Hip	Harris Hip Score (HHS)41 is a disease-specific, health-related quality of life (HRQoL) instrument, widely used as an outcome measure after THR. The domains covered are pain, function, absence of deformity and range of movement	6 months
Clinical Score about Hip	American Knee Society scoring (KSS) is a disease-specific scoring system developed to assess clinical outcomes and functional ability on patients before and after total knee arthroplasty. Knees are examined for ROM, flexion contractures, extension leg, alignment and stability; functional score rates the patient's ability to walk and climb stairs.	6 months
Pain score	Visual analog scale (VAS) is scale to measure the pain	6 months
Lower limb function	High-Activity Arthroplasty Score (HAAS) focuses on lower limb functions and was specifically developed to assess the variations in functional ability after lower limb arthroplasty with particular regard to highly functioning individuals. The score is a 4-item self-assessment measure covering the 4 domains of walking, running, stair climbing, and general activities	6 months
Disability	Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)47,48 is a valid and reliable scale, designed to provide a disease-specific measure for patients with osteoarthritis of hip and knee. It includes 24 items in three dimensions: pain (5 items), function (17 items) and stiffness (2 items).	6 months
Clinical outcome	Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item self-administered questionnaire which proved to be a reliable and valid instrument for evaluating the outcome of surgery and physical therapy50,51 for knee impairments. It includes subscales were sport and recreation function and knee-related QoL are considered. KOOS assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.	6 months
Clinical score	Hip Disability and Osteoarthritis Score (HOOS),It is a 39-item self-administered questionnaire with five separate sub-scales: pain, symptoms, stiffness, activities of daily living, sport and recreation function, and hip-related quality of life	6 months
Physical performance	Time Up and GO (TUG) is a valid and reliable test used to examine physical performance and lower extremity	6 months
Balance	Single Stance test is useful to estimate standing balance and to discriminate from low to high functional ability in individuals of various ages and functional levels	6 months
Lower body strength	The 30-second Chair-Stand Test (30s-CST) is a valid and reliable single-item test for the assessment of lower body strength	6 months
Upper limb strength	Hand Grip test	6 months
Range of Motion (ROM)	Hip range of motion in degree, knee range of motion in degree, shoulder range of motion in degree	6 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: University of Bologna
• Investigators: Principal Investigator: D Dallari, MD, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 12, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; total knee replacement; total hip replacement; total knee prosthesis; total hip prosthesis
• Other Study ID Numbers: 1005/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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