OsteoarthritisARTHANCT02933632
Accelerated Rehabilitation in Hip Arthroplasty
A study testing Physical Therapy-SAP and Physical Therapy-ARP in people with Osteoarthritis, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
Trial summary
Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Physical Therapy-SAP and Physical Therapy-ARP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesBrazil
- Study dates
- Aug 2013to Nov 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of the Public Health System of our Country that were admitted with hip osteoarthritis diagnose and submitted to a total hip arthroplasty surgery in the Hospital de Clínicas de Porto Alegre (HCPA).
Who cannot join
- Patients who refused to participate in this study;
- Patients lived in another city;
- Patients undergoing surgery for total hip arthroplasty due to hip fracture;
- Patients with cognitive disorders or diseases that adversely affect its cognitive function (Alzheimer's disease, senile dementia).
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 55
Federal University Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90040-060
About this study
Official title: Accelerated Rehabilitation Versus Conventional Rehabilitation in Total Hip Arthroplasty: A Randomized Double Blinded Clinical Trial
Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).
Read the detailed description
The accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR) was designed to improve the functionality and optimize early discharge of patients undergoing THA surgery. This study compared physical therapy protocol in Total Hip Arthroplasty (THA-PT) already deployed in Porto Alegre Clinical Hospital with THA-AR.
- Conditions
- Osteoarthritis
- Being tested
- Physical Therapy-SAP, Physical Therapy-ARP
- Keywords
- Osteoarthritis, Physiotherapy, Rehabilitation, Clinical Trials, Accelerated rehabilitation, Hip Replacement Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy-SAPOther
- Day 1) Patients started approach after discharged anesthesia. Patients received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise;
- Day 2) Patients repeated the exercises learned from day 1. Following the proposed activities patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this second day only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to the next day;
- Day 3) Patients repeated the day 2. And the patient who had not started gait training in the day 2, began it on the day 3;
- Day 4 and other days) Patients repeated the gait training until the discharge date.
Physical Therapy-ARPOther
- Day 1-1°approach) Patients started after discharged anesthesia. Received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise;
- Day 1-2°approach) Patients repeated the exercises learned from day 1-1°approach. Following patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this Day 1-2°approach only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to next approach;
- Day 1-3°approach) Patients repeat the day 1-2°approach. And the patient, who had not started gait training in the day 1 - second approach, began it in this third approach;
- Day 2) Patients repeated three times the day 1-3°approach;
- Day 3) Patients repeated three times the day 1-3°approach.
| Study group | Role | What they receive |
|---|---|---|
| Standard Assistance Protocol-SAP | Active comparator | Patients underwent physical therapy once a day. Patients receive intervention by Physical Therapy-SAP. Receives: Other: Physical Therapy-SAP |
| Accelerated Rehabilitation Protocol-ARP | Active comparator | Patients underwent physical therapy three times a day. Patients receive intervention by Physical Therapy-ARP. Receives: Other: Physical Therapy-ARP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Merle D'Aubigné and Postel score
Measured: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Secondary outcomes (4)
Length of hospital stay
Measured: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Muscle strength force
Measured based on Kendall's criteria. Measured in the operated hip.
Measured: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Goniometry
Evaluate the range of motion in flexion, extension, adduction, abduction, and internal and external rotation in the operated hip.
Measured: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Time to beginning the gait.
Measured: From the date of hospitalization until the day that began gait, assessed up to four days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Elizabeth Marchisio, Federal University of Rio Grande do Sul
- Investigators
- Carlos R Galia, Doctor, Principal investigator, Federal University Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933632
- Sponsor's protocol ID
- FederalURS
- Acronym
- ARTHA
- Status last verified
- Oct 2020
- First submitted
- 13 Apr 2015
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marchisio AE, Ribeiro TA, Umpierres CSA, GalvAo L, Rosito R, Macedo CAS, Galia CR. Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial. Rev Col Bras Cir. 2020;47:e20202548. doi: 10.1590/0100-6991e-20202548. Epub 2020 Aug 12. English, Portuguese.
PubMed 32844909
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Rehabilitation Versus Conventional Rehabilitation in Total Hip Arthroplasty: A Randomized Double Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02933632
- Acronym / sponsor ID
- ARTHA / FederalURS
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Physiotherapy, Rehabilitation, Clinical Trials, Accelerated rehabilitation, Hip Replacement Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).
Detailed description
The accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR) was designed to improve the functionality and optimize early discharge of patients undergoing THA surgery. This study compared physical therapy protocol in Total Hip Arthroplasty (THA-PT) already deployed in Porto Alegre Clinical Hospital with THA-AR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Assistance Protocol-SAP | Active comparator | Other: Physical Therapy-SAPPatients underwent physical therapy once a day. Patients receive intervention by Physical Therapy-SAP. |
| Accelerated Rehabilitation Protocol-ARP | Active comparator | Other: Physical Therapy-ARPPatients underwent physical therapy three times a day. Patients receive intervention by Physical Therapy-ARP. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of the Public Health System of our Country that were admitted with hip osteoarthritis diagnose and submitted to a total hip arthroplasty surgery in the Hospital de Clínicas de Porto Alegre (HCPA).
Key exclusion criteria (4 listed)
- Patients who refused to participate in this study;
- Patients lived in another city;
- Patients undergoing surgery for total hip arthroplasty due to hip fracture;
- Patients with cognitive disorders or diseases that adversely affect its cognitive function (Alzheimer's disease, senile dementia).
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 Therapy-SAP* Day 1) Patients started approach after discharged anesthesia. Patients received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise; * Day 2) Patients repeated the exercises learned from day 1. Following the proposed activities patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this second day only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to the next day; * Day 3) Patients repeated the day 2. And the patient who had not started gait training in the day 2, began it on the day 3; * Day 4 and other days) Patients repeated the gait training until the discharge date. | Other | Standard Assistance Protocol-SAP |
| Physical Therapy-ARP* Day 1-1°approach) Patients started after discharged anesthesia. Received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise; * Day 1-2°approach) Patients repeated the exercises learned from day 1-1°approach. Following patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this Day 1-2°approach only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to next approach; * Day 1-3°approach) Patients repeat the day 1-2°approach. And the patient, who had not started gait training in the day 1 - second approach, began it in this third approach; * Day 2) Patients repeated three times the day 1-3°approach; * Day 3) Patients repeated three times the day 1-3°approach. | Other | Accelerated Rehabilitation Protocol-ARP |
Primary outcome
Merle D'Aubigné and Postel score
Time frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
4 secondary outcomes
Length of hospital stay
Time frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Muscle strength force
Time frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Goniometry
Time frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Time to beginning the gait.
Time frame: From the date of hospitalization until the day that began gait, assessed up to four days.
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 6 Oct 2020.
- Results publication: PubMed 32844909Marchisio AE, Ribeiro TA, Umpierres CSA, GalvAo L, Rosito R, Macedo CAS, Galia CR. Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial. Rev Col Bras Cir. 2020;47:e20202548. doi: 10.1590/0100-6991e-20202548. Epub 2020 Aug 12. English, Portuguese.
- Link to publicationLink provided by the sponsor.
- 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.
Carlos R Galia, Doctor principal investigator
Federal University Rio Grande do Sul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy-SAP and Physical Therapy-ARP in people with Osteoarthritis, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
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 1 inclusion and 4 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Merle D'Aubigné and Postel score (time frame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933632, which also lists 1 linked publication.
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 6 Oct 2020.