Improve Quality of LifePAIRNCT04761367
Exercise Program After Total Hip and Knee Replacement: a Randomized Controlled Trial
A study testing Physical activity. Physical Activity program is performed in a group in a gym in people with Improve Quality of Life, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Improve Quality of Life
- What is being tested?
- Physical activity. Physical Activity program is performed in a group in a gym
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Post-surgery criteria
- Functional performance: Able to stand and walk >500 meters independently;
- Pain: score ≤ 4 in VAS
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Improve Quality of Life
- Being tested
- Physical activity. Physical Activity program is performed in a group in a gym
- Keywords
- total knee replacement, total hip replacement, Physical activity, total knee prosthesis, total hip prosthesis
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity. Physical Activity program is performed in a group in a gymOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (12)
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
Measured: 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.
Measured: 6 months
Pain score
Visual analog scale (VAS) is scale to measure the pain
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 6 months
Physical performance
Time Up and GO (TUG) is a valid and reliable test used to examine physical performance and lower extremity
Measured: 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
Measured: 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
Measured: 6 months
Upper limb strength
Hand Grip test
Measured: 6 months
Range of Motion (ROM)
Hip range of motion in degree, knee range of motion in degree, shoulder range of motion in degree
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve Quality of LifeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Sponsor
- Investigators
- D Dallari, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761367
- Sponsor's protocol ID
- 1005/2020
- Acronym
- PAIR
- Status last verified
- Sep 2024
- First submitted
- 5 Feb 2021
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PAIR Exercise Program After Total Hip and Knee Replacement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04761367
- Acronym / sponsor ID
- PAIR / 1005/2020
- Conditions
- Improve Quality of Life
- Keywords
- total knee replacement, total hip replacement, Physical activity, total knee prosthesis, total hip prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Feb 2021 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Other | Other: Physical activity. Physical Activity program is performed in a group in a gymThe 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 |
| 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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);
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 |
|---|---|---|
| Physical activity. Physical Activity program is performed in a group in a gymThe 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 | Other | INTERVENTION GROUP |
Primary outcome
Quality of life questionnaire
Time frame: 6 months
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
12 secondary outcomes
Clinical score about Hip
Time frame: 6 months
Clinical Score about Hip
Time frame: 6 months
Pain score
Time frame: 6 months
Lower limb function
Time frame: 6 months
Disability
Time frame: 6 months
Clinical outcome
Time frame: 6 months
Clinical score
Time frame: 6 months
Physical performance
Time frame: 6 months
Balance
Time frame: 6 months
Lower body strength
Time frame: 6 months
Upper limb strength
Time frame: 6 months
Range of Motion (ROM)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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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.
D Dallari, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity. Physical Activity program is performed in a group in a gym in people with Improve Quality of Life, run by Istituto Ortopedico Rizzoli 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 23 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.