Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761367
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2021-02-05
Brief Title:
Exercise Program After Total Hip and Knee Replacement a Randomized Controlled Trial
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Efficacy and Safety of PAIR Exercise Program After Total Hip and Knee Replacement a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAIR
Brief Summary:
Randomized controlled trial Patients will be enrolled at the moment of the pre-surgery assessment after verifying the inclusionexclusion 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 inclusionexclusion criteria verified again For each type of surgical procedure ie 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
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 performedtotal 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
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 performedtotal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None