Total Knee ReplacementNCT04081493
The Efficacy of Low-load Blood Flow Restricted Resistance Before TKR
A study testing Low-load blood flow restricted exercise in people with Total Knee Replacement, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The primary aim of this study is to investigate the efficacy of 8 weeks of Low-load blood flow restricted exercise (BFRE) compared to receiving standard care only (no preoperative training) before total knee replacement (TKR) on postoperative 30-seconds chair stand test (30s-CST). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Low-load blood flow restricted exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 3 sitesDenmark
- Study dates
- 17 Sep 2019to 1 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 50 years scheduled for TKA at Horsens- or Silkeborg Regional Hospital.
Who cannot join
- Severe cardiovascular diseases (New York Heart Association class III and IIII), previous stroke incident, thrombosis incident
- Traumatic nerve injury in affected limb
- Unregulated hypertension (Systolic ≥180 or diastolic ≥110 mmHg)
- Spinal cord injury
- Pregnancy
- Planned other lower limb surgery within 12 months
Show all 10Show fewer
- Cancer diagnosis and currently undergoing chemo-, immuno-, or radiotherapy
- Inadequacy in written and spoken Danish
- an existing prosthesis in the index limb
- living more than 45 minutes from either Horsens Regional Hospital or Silkeborg Regional Hospital.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hosspital
Aarhus, Aarhus N, 8200
Horsens Regional Hospital
Horsens, 8600
Silkeborg Regional Hospital
Silkeborg, 8600
About this study
Official title: The Efficacy of Low-load Blood Flow Restricted Resistance Exercise in Patients With Knee Osteoarthritis Scheduled for Total Knee Arthroplasty: A Multicenter, Randomized Controlled Trial
The primary aim of this study is to investigate the efficacy of 8 weeks of Low-load blood flow restricted exercise (BFRE) compared to receiving standard care only (no preoperative training) before total knee replacement (TKR) on postoperative 30-seconds chair stand test (30s-CST). We hypothesize that 8 weeks of preoperative BFRE will increase chair stand performance 3 months postoperatively. Secondary aims are to investigate the efficacy of 8 weeks of preoperative BFRE compared to receiving standard care only on changes in muscle strength 3 months after TKR and investigate associations to functional capacity and quality of life. Furthermore, it will be investigated if 8 weeks of BFRE induces muscle hypertrophy and increases satellite cell and myonuclei content of the vastus lateralis muscle.
Read the detailed description
BFRE is resistance training with low loads (30% 1repetition maximum (RM) performed with concurrent partial blood flow restriction by means of pneumatic cuff compression around the working limb.
Group 1 (BFRE):
BFRE group: Will perform 3/weekly supervised BFRE sessions for 8 weeks from a physiotherapist educated in administering BFRE. Each session will consist of a 10-min warm up followed by two different unilateral lower-limb resistance training exercises: leg press and knee extension. Each exercise will be performed with the affected lower limb only and consist of 4 rounds interspaced by 30 seconds of rest. 1st round: 30 repetitions (reps); 2nd round: 15 reps; 3rd round: 15 reps; 4th round: until exhaustion. Between each exercise the patients will rest for 5 minutes without blood flow restriction.
Patients will rest in a standardized resting position between each set to maintain the desired resting cuff-pressure.
The occlusion pressure will be set at 60% of total limb occlusion pressure and starting load intensity will be 30% 1repetition maximum (1RM) in both exercises. If patients can perform more than 15 repetitions in the 4th exercise set, the exercise load will be increased with the minimum extra load possible.
Group 2 (control Group):
CON group: Will follow standard procedures before a TKA and be encouraged to live their lives as usual up until TKA.
The study is a multicenter (2 sites), randomized (allocation 1:1), assessor blinded, controlled trial Outcomes will be measured at baseline (9-10 weeks before surgery), in the week of surgery and 3- and 12 months postoperatively. Muscle biopsies will be taken from all patients undergoing surgery at Horsens Regional Hospital. Muscle biopsies will be taken at baseline, during surgery and 3 months postoperatively.
The 12 months follow-up assessment will be analyzed and presented in papers during a subsequent Post Doc-period.
All patients will be scheduled to receive TKR and receive a standard multimodal surgical program with standardized perioperative care. Specifically, all patients will be invited to a preoperative information meeting 2-3 weeks prior to surgery where nurses, surgeons, and physiotherapists will be providing detailed information about pain management, nutrition, the surgical procedure (i.e. basic knowledge about a prosthesis, risks related to smoking, restrictions related to living with a TKR, long-term results, and living with a TKR), physical activity, postoperative home-based rehabilitation, load-management, etc.
On the day of surgery patients will be hospitalized at one of the two orthopedic departments and TKR procedures will be performed by an orthopedic surgeon. The day after surgery patients will be trained once or twice per day by a physiotherapist towards fulfilling the following discharge criterions: independency in in-and-out of bed and sit-to-stand activities, independency in walking and stair-negotiation with crutches, ADL activities, and home-based exercises during the hospitalization period. Patients will generally be discharged within ~1-2 days after fulfilling all the above discharge criteria. After discharge, all patients will receive a standard home-based rehabilitation program aimed at increasing knee mobility and lower extremity muscle strength. However, if considered necessary by the physiotherapist in charge of the patient, patients can receive additional supervised knee-specific exercise therapy at private physiotherapy clinics, municipal rehabilitation centers, or specialized hospital-based rehabilitation.
- Conditions
- Total Knee Replacement
- Being tested
- Low-load blood flow restricted exercise
- Keywords
- Low-load blood flow restricted exercise, Preconditioning, Functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-load blood flow restricted exerciseOther
Leg press and knee extension exercise 3 times per week for 8 weeks. Repetition scheme: 30-15-15-until exhaustion interspaced by 30 sec rest. 5 min "free-flow" rest between exercises
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (BFRE) | Experimental | Low-load blood flow restricted exercise 3/weekly for 8 weeks before TKR 10-min warm-up followed by unilateral leg press and unilateral knee extension Receives: Other: Low-load blood flow restricted exercise |
| Group 2 (CON) | No intervention | No training before TKR |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-seconds chair stand test (30-sec CST)
The 30s-CST measures the number of sit-to-stand repetitions completed within 30 seconds. Patients will be instructed to perform a sit-to-stand movement starting from a seated position (seat height 43 cm without armrests) having the feet placed flat on the floor shoulder width apart, and arms crossed on chest to a standing position (hip and knee joints fully extended) repeated as many times as possible for 30 seconds.
Measured: change in 30-sec CST from baseline to 3 months after surgery
Secondary outcomes (10)
Timed Up & Go
The TUG assesses the time required for patients to stand from a chair (seat height 46 cm) walk around a tape mark 3 meters away and sit into the chair at return.
Measured: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
4x10 meter fast-paced walk test (40m-FWT)
The 40m fast-paced walk test (40m-FWT) measures the total time taken to walk 4 x 10 m excluding turns (meter/sec).
Measured: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
1RM leg press strength
1 Repetition maximum (RM) is the maximal load (kg) a patient is able to concentrically press in the leg press machine. The 1RM will be estimated from a 5-8RM leg press test. The 1RM will be calculated as [1RM = load (kg)/1.0278-0.0278·number of repetitions)
Measured: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
1RM knee extension strength
1 Repetition maximum (RM) is the maximal load (kg) a patient is able to concentrically lift in the knee extension machine. The 1RM will be estimated from a 5-8RM leg press test. The 1RM will be calculated as [1RM = load (kg)/1.0278-0.0278·number of repetitions)
Measured: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
Isometric knee extensor strength
Isometric knee extensor muscle strength will be assed with the participants seated on a examination table with knees and hip positioned at 90 degree flexion. Assessment of muscle strength will be performed with a hand-held dynamometer, fixed with an adjustable rigid belt to the examination table.
Measured: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
Isometric knee flexor strength
Isometric knee flexor muscle strength will be assed with the participants seated on a examination table with knees and hip positioned at 90 degree flexion. Assessment of muscle strength will be performed with a hand-held dynamometer, fixed with an adjustable rigid belt to the examination table.
Measured: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
Muscle biopsy sampling and analysis - myofiber morphology (cross sectional area, fiber type composition, myonuclei number) and myogenic stemm cell (satellite cell) content
needle biopsies (100-150 mg) will be obtained from the vastus lateralis muscle of patients undergoing TKR at Horsens Regional Hospital
Measured: Measured at baseline, in the week of surgery, and 3 months after surgery
Knee disability and Osteoarthritis Outcome Score (KOOS)
KOOS is a patient-administered knee specific questionnaire comprising five subscales Pain; Symptoms; Activities of daily living; Sport \& Recreation; and Knee-Related Quality of Life.
Measured: Measured at baseline, in the week of surgery, 6 weeks after surgery, 3 months after surgery, and 12 months after surgery
EuroQol Group 5-dimension (EQ-5D-5L)
The EQ-5D-L5 is a self-completion questionnaire consisting of two parts; first part of the EQ-5D-5L comprises five dimensions involving mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Measured at baseline, in the week of surgery, 6 weeks after surgery, 3 months after surgery, and 12 months after surgery
Adverse events
Adverse events will be defined as unpredicted or unintended events, signs, or disease occurring during the period from inclusion until the 3-month follow-up (primary end-point) resulting in contact with the healthcare system (hospital or general practitioner) independent of whether or not the event is related to the intervention or outcome assessments
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start17 Sep 2019
- Primary completion10 Jun 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Horsens Hospital, Regionshospitalet Silkeborg
- Responsible party
- Sponsor
- Investigators
- Stian L Jørgensen, MSc, Principal investigator, Department of Physio and Occupational Therapy, Horsens Regional HospitalInger Mechlenburg, DMSc, PhD, Study director, Department of Clinical Medicine, Aarhus University, DenmarkPer Aagaard, Prof, PhD, Study director, Department of Sports Science and Clinical BiomechanicsMarie B Bohn, PhD, Study director, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081493
- Sponsor's protocol ID
- Okklusionsprojektet
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Horsens Regional is responsible for handling all personal data provided by both sites in accordance to the Clinical Trial Agreement and the EU General Data Protection Regulation (GDPR)
Publications
Jorgensen SL, Aagaard P, Bohn MB, Hansen P, Hansen PM, Holm C, Mortensen L, Garval M, Tonning LU, Mechlenburg I. The Effect of Blood Flow Restriction Exercise Prior to Total Knee Arthroplasty on Postoperative Physical Function, Lower Limb Strength and Patient-Reported Outcomes: A Randomized Controlled Trial. Scand J Med Sci Sports. 2024 Nov;34(11):e14750. doi: 10.1111/sms.14750.
PubMed 39461901Langgard Jorgensen S, Mechlenburg I, Bagger Bohn M, Aagaard P. Sit-to-stand power predicts functional performance and patient-reported outcomes in patients with advanced knee osteoarthritis. A cross-sectional study. Musculoskelet Sci Pract. 2024 Feb;69:102899. doi: 10.1016/j.msksp.2023.102899. Epub 2023 Dec 17.
PubMed 38141496Jorgensen SL, Bohn MB, Aagaard P, Mechlenburg I. Efficacy of low-load blood flow restricted resistance EXercise in patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee): protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Oct 1;10(10):e034376. doi: 10.1136/bmjopen-2019-034376.
PubMed 33004382
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Low-load Blood Flow Restricted Resistance Exercise in Patients With Knee Osteoarthritis Scheduled for Total Knee Arthroplasty: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04081493
- Acronym / sponsor ID
- Okklusionsprojektet
- Conditions
- Total Knee Replacement
- Keywords
- Low-load blood flow restricted exercise, Preconditioning, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Horsens Hospital, Regionshospitalet Silkeborg
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 9 Sep 2019 (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.
The primary aim of this study is to investigate the efficacy of 8 weeks of Low-load blood flow restricted exercise (BFRE) compared to receiving standard care only (no preoperative training) before total knee replacement (TKR) on postoperative 30-seconds chair stand test (30s-CST). We hypothesize that 8 weeks of preoperative BFRE will increase chair stand performance 3 months postoperatively. Secondary aims are to investigate the efficacy of 8 weeks of preoperative BFRE compared to receiving standard care only on changes in muscle strength 3 months after TKR and investigate associations to functional capacity and quality of life. Furthermore, it will be investigated if 8 weeks of BFRE induces muscle hypertrophy and increases satellite cell and myonuclei content of the vastus lateralis muscle.
Detailed description
BFRE is resistance training with low loads (30% 1repetition maximum (RM) performed with concurrent partial blood flow restriction by means of pneumatic cuff compression around the working limb.
Group 1 (BFRE):
BFRE group: Will perform 3/weekly supervised BFRE sessions for 8 weeks from a physiotherapist educated in administering BFRE. Each session will consist of a 10-min warm up followed by two different unilateral lower-limb resistance training exercises: leg press and knee extension. Each exercise will be performed with the affected lower limb only and consist of 4 rounds interspaced by 30 seconds of rest. 1st round: 30 repetitions (reps); 2nd round: 15 reps; 3rd round: 15 reps; 4th round: until exhaustion. Between each exercise the patients will rest for 5 minutes without blood flow restriction.
Patients will rest in a standardized resting position between each set to maintain the desired resting cuff-pressure.
The occlusion pressure will be set at 60% of total limb occlusion pressure and starting load intensity will be 30% 1repetition maximum (1RM) in both exercises. If patients can perform more than 15 repetitions in the 4th exercise set, the exercise load will be increased with the minimum extra load possible.
Group 2 (control Group):
CON group: Will follow standard procedures before a TKA and be encouraged to live their lives as usual up until TKA.
The study is a multicenter (2 sites), randomized (allocation 1:1), assessor blinded, controlled trial Outcomes will be measured at baseline (9-10 weeks before surgery), in the week of surgery and 3- and 12 months postoperatively. Muscle biopsies will be taken from all patients undergoing surgery at Horsens Regional Hospital. Muscle biopsies will be taken at baseline, during surgery and 3 months postoperatively.
The 12 months follow-up assessment will be analyzed and presented in papers during a subsequent Post Doc-period.
All patients will be scheduled to receive TKR and receive a standard multimodal surgical program with standardized perioperative care. Specifically, all patients will be invited to a preoperative information meeting 2-3 weeks prior to surgery where nurses, surgeons, and physiotherapists will be providing detailed information about pain management, nutrition, the surgical procedure (i.e. basic knowledge about a prosthesis, risks related to smoking, restrictions related to living with a TKR, long-term results, and living with a TKR), physical activity, postoperative home-based rehabilitation, load-management, etc.
On the day of surgery patients will be hospitalized at one of the two orthopedic departments and TKR procedures will be performed by an orthopedic surgeon. The day after surgery patients will be trained once or twice per day by a physiotherapist towards fulfilling the following discharge criterions: independency in in-and-out of bed and sit-to-stand activities, independency in walking and stair-negotiation with crutches, ADL activities, and home-based exercises during the hospitalization period. Patients will generally be discharged within ~1-2 days after fulfilling all the above discharge criteria. After discharge, all patients will receive a standard home-based rehabilitation program aimed at increasing knee mobility and lower extremity muscle strength. However, if considered necessary by the physiotherapist in charge of the patient, patients can receive additional supervised knee-specific exercise therapy at private physiotherapy clinics, municipal rehabilitation centers, or specialized hospital-based rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (BFRE) | Experimental | Other: Low-load blood flow restricted exerciseLow-load blood flow restricted exercise 3/weekly for 8 weeks before TKR 10-min warm-up followed by unilateral leg press and unilateral knee extension |
| Group 2 (CON) | No intervention | –No training before TKR |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 50 years scheduled for TKA at Horsens- or Silkeborg Regional Hospital.
Key exclusion criteria (10 listed)
- Severe cardiovascular diseases (New York Heart Association class III and IIII), previous stroke incident, thrombosis incident
- Traumatic nerve injury in affected limb
- Unregulated hypertension (Systolic ≥180 or diastolic ≥110 mmHg)
- Spinal cord injury
- Pregnancy
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 |
|---|---|---|
| Low-load blood flow restricted exerciseLeg press and knee extension exercise 3 times per week for 8 weeks. Repetition scheme: 30-15-15-until exhaustion interspaced by 30 sec rest. 5 min "free-flow" rest between exercises | Other | Group 1 (BFRE) |
Primary outcome
30-seconds chair stand test (30-sec CST)
Time frame: change in 30-sec CST from baseline to 3 months after surgery
The 30s-CST measures the number of sit-to-stand repetitions completed within 30 seconds. Patients will be instructed to perform a sit-to-stand movement starting from a seated position (seat height 43 cm without armrests) having the feet placed flat on the floor shoulder width apart, and arms crossed on chest to a standing position (hip and knee joints fully extended) repeated as many times as possible for 30 seconds.
10 secondary outcomes
Timed Up & Go
Time frame: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
4x10 meter fast-paced walk test (40m-FWT)
Time frame: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
1RM leg press strength
Time frame: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
1RM knee extension strength
Time frame: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
Isometric knee extensor strength
Time frame: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
Isometric knee flexor strength
Time frame: Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery
Muscle biopsy sampling and analysis - myofiber morphology (cross sectional area, fiber type composition, myonuclei number) and myogenic stemm cell (satellite cell) content
Time frame: Measured at baseline, in the week of surgery, and 3 months after surgery
Knee disability and Osteoarthritis Outcome Score (KOOS)
Time frame: Measured at baseline, in the week of surgery, 6 weeks after surgery, 3 months after surgery, and 12 months after surgery
EuroQol Group 5-dimension (EQ-5D-5L)
Time frame: Measured at baseline, in the week of surgery, 6 weeks after surgery, 3 months after surgery, and 12 months after surgery
Adverse events
Time frame: 3 months after surgery
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 19 Sep 2024.
- Derived from this study: PubMed 39461901Jorgensen SL, Aagaard P, Bohn MB, Hansen P, Hansen PM, Holm C, Mortensen L, Garval M, Tonning LU, Mechlenburg I. The Effect of Blood Flow Restriction Exercise Prior to Total Knee Arthroplasty on Postoperative Physical Function, Lower Limb Strength and Patient-Reported Outcomes: A Randomized Controlled Trial. Scand J Med Sci Sports. 2024 Nov;34(11):e14750. doi: 10.1111/sms.14750.
- Derived from this study: PubMed 38141496Langgard Jorgensen S, Mechlenburg I, Bagger Bohn M, Aagaard P. Sit-to-stand power predicts functional performance and patient-reported outcomes in patients with advanced knee osteoarthritis. A cross-sectional study. Musculoskelet Sci Pract. 2024 Feb;69:102899. doi: 10.1016/j.msksp.2023.102899. Epub 2023 Dec 17.
- Derived from this study: PubMed 33004382Jorgensen SL, Bohn MB, Aagaard P, Mechlenburg I. Efficacy of low-load blood flow restricted resistance EXercise in patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee): protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Oct 1;10(10):e034376. doi: 10.1136/bmjopen-2019-034376.
- Individual participant dataSharing planned: Yes. Horsens Regional is responsible for handling all personal data provided by both sites in accordance to the Clinical Trial Agreement and the EU General Data Protection Regulation (GDPR)
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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.
Stian L Jørgensen, MSc principal investigator
Department of Physio and Occupational Therapy, Horsens Regional Hospital
Inger Mechlenburg, DMSc, PhD study director
Department of Clinical Medicine, Aarhus University, Denmark
Per Aagaard, Prof, PhD study director
Department of Sports Science and Clinical Biomechanics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-load blood flow restricted exercise in people with Total Knee Replacement, run by University of Aarhus at 3 sites 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 1 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: finished, as of the sponsor's last update on 19 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 3 sites 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?
30-seconds chair stand test (30-sec CST) (time frame: change in 30-sec CST from baseline to 3 months after surgery). 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 NCT04081493, which also lists 3 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 19 Sep 2024.