Osteoarthritis, HipNCT01214954
Early Rehabilitation After Total Hip Replacement
A study testing Supervised progressive resistance training in people with Osteoarthritis, Hip, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Supervised progressive resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total hip replacement for osteoarthrosis
- Living within 30 km from the hospital
- Motivated to attend training 2 times/week in 10 weeks
- Reduced functional ability measured as: HOOS score < 67
- written informed consent
Who cannot join
- Comorbidities such as cancer, neuromuscular diseases, heart diseases etc.
- Cognitive impairment
- Body mass index > 35
- Resurfacing prosthesis
- Scheduled additional prosthetic surgery in lower extremity within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Rehabilitation After Toal Hip Replacement. -Effect of Supervised Progressive Resistance Training
The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise.
Read the detailed description
After total hip replacement (THR) surgery there is a documented deficit in muscle strength and functional performance. There is a lack of evidence concerning the effectiveness of postoperative physiotherapy and training, however a few small studies have shown promising effect of resistance training.
The present study will provide new and important knowledge concerning the effect of different rehabilitation strategies after THR. This might lead to a change in the rehabilitation regimes and faster and better recovery after THR surgery.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Supervised progressive resistance training, Control group
- Keywords
- Total Hip Replacement, Rehabilitation, Resistance training
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised progressive resistance trainingOther
Resistance training 2 times/week initiated within the first week after total hip replacement. The training is supervised by physiotherapists and individually progressed.
Control groupOther
Standard rehabilitation consisting of home-based exercises with 2 postoperative instructions by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard rehabilitation Receives: Other: Control group |
| Resistance training | Experimental | 10 weeks of supervised progressive resistance training initiated within the first week after total hip replacement. Receives: Other: Supervised progressive resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg extension power
The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)
Measured: 10 weeks postoperative
Secondary outcomes (19)
Walking speed
Maximal walking speed measured over 20 m.
Measured: 4 weeks postoperative
Sit-to-stand
The maximal number of rises from a chair within 30 seconds
Measured: 10 weeks postoperative
Stair test
The time taken to ascend 18 steps as fast as possible
Measured: 10 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Measured: 6 months postoperative
Walking speed
Maximal walking speed measured over 20 m.
Measured: 10 weeks
Walking speed
Maximal walking speed measured over 20 m.
Measured: 6 months postoperative
Leg extension power
The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)
Measured: 6 months postoperative
Sit-to-stand
The maximal number of rises from a chair within 30 seconds
Measured: 6 months postoperative
Stair test
The time taken to ascend 18 steps as fast as possible
Measured: 6 months postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Measured: 2 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Measured: 4 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Measured: 6 weeks postoperative
Isometric muscle strength
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Measured: 4 weeks postoperative
Isometric muscle strength
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Measured: 10 weeks postoperative
Isometric muscle strength
Test of isometric muscle strength in hip abduction and hip flexion using hand-held dynamometry
Measured: 6 months postoperative
Gait quality
Instrumented gait analysis using a combined accelerometer and gyro-sensor in 20 meter walk test and stair climb test. The purpose is to measure asymmetry between limps during walking and stair climbing and compare the two groups according to these variables. This outcome measure is performed on a subgroup of participants (n=26, 13 in each group)
Measured: 10 weeks postoperative
Gait quality
Instrumented gait analysis using a combined accelerometer and gyro-sensor in 20 meter walk test and stair climb test. The purpose is to measure asymmetry between limps during walking and stair climbing and compare the two groups according to these variables. This outcome measure is performed on a subgroup of participants (n=26, 13 in each group)
Measured: 6 months postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Measured: 10 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Questionnaire. A disease-specific patient reported outcome measure of function, pain, sport/recreation and quality of life related to the hip.
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Silkeborg
- Responsible party
- Sponsor
- Investigators
- Lone R Mikkelsen, MSc., Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214954
- Sponsor's protocol ID
- M-20090231
- Status last verified
- Nov 2013
- First submitted
- 17 Sep 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mikkelsen LR, Petersen AK, Mechlenburg I, Mikkelsen S, Soballe K, Bandholm T. Description of load progression and pain response during progressive resistance training early after total hip arthroplasty: secondary analyses from a randomized controlled trial. Clin Rehabil. 2017 Jan;31(1):11-22. doi: 10.1177/0269215516628305. Epub 2016 Jul 10.
PubMed 26851251Mikkelsen LR, Mechlenburg I, Soballe K, Jorgensen LB, Mikkelsen S, Bandholm T, Petersen AK. Effect of early supervised progressive resistance training compared to unsupervised home-based exercise after fast-track total hip replacement applied to patients with preoperative functional limitations. A single-blinded randomised controlled trial. Osteoarthritis Cartilage. 2014 Dec;22(12):2051-8. doi: 10.1016/j.joca.2014.09.025. Epub 2014 Oct 22.
PubMed 25305374
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation After Toal Hip Replacement. -Effect of Supervised Progressive Resistance Training
- ClinicalTrials.gov ID
- NCT01214954
- Acronym / sponsor ID
- M-20090231
- Conditions
- Osteoarthritis, Hip
- Keywords
- Total Hip Replacement, Rehabilitation, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Silkeborg
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Oct 2010 (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.
The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise.
Detailed description
After total hip replacement (THR) surgery there is a documented deficit in muscle strength and functional performance. There is a lack of evidence concerning the effectiveness of postoperative physiotherapy and training, however a few small studies have shown promising effect of resistance training.
The present study will provide new and important knowledge concerning the effect of different rehabilitation strategies after THR. This might lead to a change in the rehabilitation regimes and faster and better recovery after THR surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupStandard rehabilitation |
| Resistance training | Experimental | Other: Supervised progressive resistance training10 weeks of supervised progressive resistance training initiated within the first week after total hip replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Total hip replacement for osteoarthrosis
- Living within 30 km from the hospital
- Motivated to attend training 2 times/week in 10 weeks
- Reduced functional ability measured as: HOOS score < 67
- written informed consent
Key exclusion criteria (5 listed)
- Comorbidities such as cancer, neuromuscular diseases, heart diseases etc.
- Cognitive impairment
- Body mass index > 35
- Resurfacing prosthesis
- Scheduled additional prosthetic surgery in lower extremity within 6 months
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 |
|---|---|---|
| Supervised progressive resistance trainingResistance training 2 times/week initiated within the first week after total hip replacement. The training is supervised by physiotherapists and individually progressed. | Other | Resistance training |
| Control groupStandard rehabilitation consisting of home-based exercises with 2 postoperative instructions by a physiotherapist. | Other | Control group |
Primary outcome
Leg extension power
Time frame: 10 weeks postoperative
The power in leg extension is measured using the Nottingham leg extension power rig. Data is provided in watt and adjusted for bodyweight (watt/kg)
19 secondary outcomes
Walking speed
Time frame: 4 weeks postoperative
Sit-to-stand
Time frame: 10 weeks postoperative
Stair test
Time frame: 10 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time frame: 6 months postoperative
Walking speed
Time frame: 10 weeks
Walking speed
Time frame: 6 months postoperative
Leg extension power
Time frame: 6 months postoperative
Sit-to-stand
Time frame: 6 months postoperative
Stair test
Time frame: 6 months postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time frame: 2 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time frame: 4 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time frame: 6 weeks postoperative
Isometric muscle strength
Time frame: 4 weeks postoperative
Isometric muscle strength
Time frame: 10 weeks postoperative
Isometric muscle strength
Time frame: 6 months postoperative
Gait quality
Time frame: 10 weeks postoperative
Gait quality
Time frame: 6 months postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time frame: 10 weeks postoperative
Hip Osteoarthritis Outcome Score (HOOS)
Time frame: 1 year postoperative
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 25 Nov 2013.
- Derived from this study: PubMed 26851251Mikkelsen LR, Petersen AK, Mechlenburg I, Mikkelsen S, Soballe K, Bandholm T. Description of load progression and pain response during progressive resistance training early after total hip arthroplasty: secondary analyses from a randomized controlled trial. Clin Rehabil. 2017 Jan;31(1):11-22. doi: 10.1177/0269215516628305. Epub 2016 Jul 10.
- Derived from this study: PubMed 25305374Mikkelsen LR, Mechlenburg I, Soballe K, Jorgensen LB, Mikkelsen S, Bandholm T, Petersen AK. Effect of early supervised progressive resistance training compared to unsupervised home-based exercise after fast-track total hip replacement applied to patients with preoperative functional limitations. A single-blinded randomised controlled trial. Osteoarthritis Cartilage. 2014 Dec;22(12):2051-8. doi: 10.1016/j.joca.2014.09.025. Epub 2014 Oct 22.
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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.
Lone R Mikkelsen, MSc. principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised progressive resistance training in people with Osteoarthritis, Hip, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 5 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 25 Nov 2013. 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 Denmark. 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?
Leg extension power (time frame: 10 weeks postoperative). 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 NCT01214954, which also lists 2 linked publications.
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 25 Nov 2013.