Hip OsteoarthritisNCT03208829
Exercises in the Post-operative Rehabilitation of THA
A study testing Rehabilitation exercises and Postoperative guidance in people with Hip Osteoarthritis, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Rehabilitation exercises and Postoperative guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 4 May 2018to Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
- Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
- Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.
Who cannot join
- Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
- previous surgical procedures in the coxofemoral joint;
- surgical procedures and osteoarticular diseases in the lumbar spine;
- osteoarticular diseases in lower limb joints;
- muscle injuries in lower limbs;
- presence of signs or symptoms of osteoarthritis in the contralateral hip;
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- postoperative complications such as prosthesis dislocation, deep venous thrombosis, periarticular fractures and neural lesions;
- intra-articular injection of corticosteroids in the lower limbs during the last six months;
- cardiovascular diseases with presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
- presence of neurological diseases.
Trial locations and contacts
1 site in 1 country.
Marcelo F Silva, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Federal Health Science University of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Marcelo F Silva, PhD, marcelofs@ufcspa.edu.br
Bruno M Baroni, PhD, bruno.baroni@yahoo.com.br
About this study
Official title: Effects of an Exercise Program Based on Muscle Strengthening in the Rehabilitation of Individuals Undergoing Total Hip Arthroplasty: a Randomized Clinical Trial.
Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening.
Read the detailed description
Individuals with osteoarthritis (OA) of the hip submitted to total hip arthroplasty (THA) may present alterations in their functional capacity, and associated, among other aspects, the reduction in muscle strength. Our overall objective is to compare the effects of an exercise program based on training of muscular strength to orientations and functional home exercises in patients submitted to THA, as well as to compare the outcomes of both groups with those of healthy individuals. Individuals with THA will be randomly assigned to two groups. One group will receive face-to-face treatment (G1) and the other will receive postoperative guidance (G2). A blinded appraiser regarding the allocation will apply the evaluation tools at the moments: preintervention, after completing 7 days and after 10 weeks of the end of the treatment. The research will present as clinical outcomes: the muscular strength, through the values of torque peaks obtained in dynamometry; the functional capacity through the results of the Timed Up and Go test and the Harris Hip Score questionnaire; the range of joint motion measured with and flexometer; the pain through the results of the numerical scale of pain; and kinesiophobia, through the scores obtained in the Tampa Scale.
- Conditions
- Hip Osteoarthritis
- Being tested
- Rehabilitation exercises, Postoperative guidance
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation exercisesOther
Patients in group 1 will participate in a physical exercise protocol supervised by a physiotherapist. The sessions will focus on the rehabilitation of muscle strength and the exercises will be performed with increased external load.
Postoperative guidanceOther
Group 2 will receive only guidelines regarding postoperative care.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Rehabilitation Exercises Group 1 will be submitted to an exercise protocol based on muscle strength training, with duration of 6 weeks and frequency of two weekly sessions, lasting 45 minutes. Receives: Other: Rehabilitation exercises |
| Group 2 | Active comparator | Postoperative guidance Group 2 will receive an orientation booklet and weekly links from researchers to address possible questions. Receives: Other: Postoperative guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Weeks Post-Intervention Muscle Strength
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Measured: Will be measured post intervention 6 weeks after intervention).
Secondary outcomes (6)
Functional Capacity (TUG)
Functional capacity will be evaluated through the timed up and go test.
Measured: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Functional Capacity (HHS)
Functional capacity will be evaluated through the harris hip score questionnaire.
Measured: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Hip Range of Motion
Hip range of motion will be measured with a flexometer and presented in degrees of movement.
Measured: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Pain in the operated hip (last seven days)
The patient will be asked about pain felt in the operated hip within the last 7 days. Pain will be assessed with the numeric pain scale and will be represented by the number selected by the patient.
Measured: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
1 Week Post-Intervention Muscle Strength
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
Measured: Will be measured post intervention (1 week after intervention).
Pre-Intervention Muscle Strength
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m)
Measured: Will be measured pre-intervention (30 days after the surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start4 May 2018
- Primary completionJul 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Model description
- Patients with total hip arthroplasty, will be assigned to two different treatment groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruna de Moraes Lopes, Federal University of Health Science of Porto Alegre
- Investigators
- Bruna M Lopes, PhD Student, Principal investigator, Federal Health Science University of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208829
- Sponsor's protocol ID
- THA Rehabilitation
- Status last verified
- Apr 2020
- First submitted
- 1 Jul 2017
- Last updated
- 7 Apr 2020
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Program Based on Muscle Strengthening in the Rehabilitation of Individuals Undergoing Total Hip Arthroplasty: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03208829
- Acronym / sponsor ID
- THA Rehabilitation
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 6 Jul 2017 (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.
Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening.
Detailed description
Individuals with osteoarthritis (OA) of the hip submitted to total hip arthroplasty (THA) may present alterations in their functional capacity, and associated, among other aspects, the reduction in muscle strength. Our overall objective is to compare the effects of an exercise program based on training of muscular strength to orientations and functional home exercises in patients submitted to THA, as well as to compare the outcomes of both groups with those of healthy individuals. Individuals with THA will be randomly assigned to two groups. One group will receive face-to-face treatment (G1) and the other will receive postoperative guidance (G2). A blinded appraiser regarding the allocation will apply the evaluation tools at the moments: preintervention, after completing 7 days and after 10 weeks of the end of the treatment. The research will present as clinical outcomes: the muscular strength, through the values of torque peaks obtained in dynamometry; the functional capacity through the results of the Timed Up and Go test and the Harris Hip Score questionnaire; the range of joint motion measured with and flexometer; the pain through the results of the numerical scale of pain; and kinesiophobia, through the scores obtained in the Tampa Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with total hip arthroplasty, will be assigned to two different treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Rehabilitation exercisesRehabilitation Exercises Group 1 will be submitted to an exercise protocol based on muscle strength training, with duration of 6 weeks and frequency of two weekly sessions, lasting 45 minutes. |
| Group 2 | Active comparator | Other: Postoperative guidancePostoperative guidance Group 2 will receive an orientation booklet and weekly links from researchers to address possible questions. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
- Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
- Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.
Key exclusion criteria (10 listed)
- Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
- previous surgical procedures in the coxofemoral joint;
- surgical procedures and osteoarticular diseases in the lumbar spine;
- osteoarticular diseases in lower limb joints;
- muscle injuries in lower limbs;
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 |
|---|---|---|
| Rehabilitation exercisesPatients in group 1 will participate in a physical exercise protocol supervised by a physiotherapist. The sessions will focus on the rehabilitation of muscle strength and the exercises will be performed with increased external load. | Other | Group 1 |
| Postoperative guidanceGroup 2 will receive only guidelines regarding postoperative care. | Other | Group 2 |
Primary outcome
6 Weeks Post-Intervention Muscle Strength
Time frame: Will be measured post intervention 6 weeks after intervention).
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
6 secondary outcomes
Functional Capacity (TUG)
Time frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Functional Capacity (HHS)
Time frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Hip Range of Motion
Time frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
Pain in the operated hip (last seven days)
Time frame: Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).
1 Week Post-Intervention Muscle Strength
Time frame: Will be measured post intervention (1 week after intervention).
Pre-Intervention Muscle Strength
Time frame: Will be measured pre-intervention (30 days after the surgery).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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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.
Marcelo F Silva, PhD contact
Bruna M Lopes, PhD Student principal investigator
Federal Health Science University of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation exercises and Postoperative guidance in people with Hip Osteoarthritis, run by Federal University of Health Science of Porto Alegre at 1 site 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Apr 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruna M Lopes, PhD Student (+5551993276096, blopes.fisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Weeks Post-Intervention Muscle Strength (time frame: Will be measured post intervention 6 weeks after intervention).). 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 7 Apr 2020.