Hip FracturesNCT05389800
Pre- and Post-Operative Exercise in Patients With Hip Fracture
A study testing Upper Extremity Aerobic Exercise in people with Hip Fractures, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The purposes of this study are to determine the benefits of a pre-operative aerobic exercise program and an 8-week postoperative aerobic exercise program with a portable upper extremity cycle-ergometer in patients with hip fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Upper Extremity Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2024to Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age: 65 years old and older
- Unilateral proximal femoral fracture/hip fracture (intertrochanteric or neck fracture)
- Ambulatory patients before fracture (with or without aid assistance)
- Agreed to participate and signed consent form
Who cannot join
- Pathological fractures (under musculoskeletal oncology)
- Severe neuropsychiatric disorder (eg severe psychiatric disorder, dementia, etc.) to the extent that the researcher deems the patient incompetent or likely unable to remain compliant with the follow-up
- Unable to implement the exercise program due to underlying pathology or disability in the upper extremities
- More than one fracture
- Severe and / or unstable cardiovascular disease [e.g. congenital heart disease, uncontrolled severe hypertension (systolic blood pressure ≥ 180 mmHg and / or diastolic blood pressure ≥ 120 mmHg), unstable angina]
- Neurological or other conditions that significantly impair function and independence (eg stage 3-5 Parkinson's disease according to Hoehn and Yahr, advanced Multiple Sclerosis, severe arthritis of degenerative or rheumatic etiology)
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- Severe metabolic bone disease (eg Paget's disease, renal bone disease, osteomalacia), excluding osteoporosis
- Active deadly aggressive disease (eg end-stage cancer with an estimated survival expectancy of less than 6 months)
- Unable to understand the consent document and / or protocol instructions
- Refusal to participate in the research
Trial locations and contacts
1 site in 1 country.
Greece1 site
1st Department of Orthopaedic Surgery, Medical School, National and Kapodistrian University of Athens
Athens, Attica, 12462
About this study
Official title: Pre- and Post-Operative Effects of Upper Extremity Aerobic Exercise in Mobility, Haemostatic Balance, and Mortality- and Morbidity-related Biomarkers in Hip Fracture Patients: A Randomized Controlled Trial
The purposes of this study are to determine the benefits of a pre-operative aerobic exercise program and an 8-week postoperative aerobic exercise program with a portable upper extremity cycle-ergometer in patients with hip fracture.
Read the detailed description
Hip fracture is one of the primary causes of significant morbidity in those over than 65 years old. Hip fracture is also among the top ten causes of loss of disability-adjusted life years in elderly. For the year 2020, in terms of the percentage of population over 80 years, Greece was second among the countries of the European Union, with this age group constituting 7.2% of its total population. In Greece, between 1977 and 2007, hip fractures doubled, with the annual impact rising to 343.96 per 100,000 inhabitants. For this population, a critical part of management is physical activity and exercise prescription both to prevent complications and to enhance rehabilitation after surgery. Postoperative (post-discharge) aerobic exercise programs of moderate intensity have already been used in patients with hip fracture proving its safety and positive effect in a variety of outcomes, such as aerobic capacity and quality of life. It is well established that these patients do not meet the minimum least amount of activity that should be done per week, based on Guidelines for Physical Activity by the World Health Organization neither during their hospitalization nor during their later life in the community. Also, although most Clinical Guidelines recommend a surgical management within 48 hours after hip trauma, there are many patient and system factors which can contribute to delayed surgery, such as surgical readiness, available resources, prioritisation and out-of-hours admission.
In terms of pre-operative exercise program, the investigators hypothesize that it will reduce surgical stress through the body's better response to lactate accumulation and the acute physiological effects on the patient's hematopoietic activity and hemostatic profile. Moderate intensity exercise will reduce platelet hyperactivity, increase fibrinolytic activity and reduce coagulation factors. In this more favorable environment, the immediate postoperative recovery of basic mobility can be accelerated. Regarding the post-operative exercise program, the investigators hypothesize that it will improve the independence and function of the lower extremity by increasing the cardiopulmonary capacity, while the improvement of the nutritional factors (albumin and pre-albumin) through the post-training protein synthesis will also contribute to this.
Apart from primary and secondary outcomes, at baseline the investigators will also evaluate the following: demographics; characteristics about the fracture and upcoming surgery, such as the type of fracture and the surgical procedure; New Mobility Score (NMS) to define the prefracture functional level; Addenbrooke's Cognitive Examination - III (ACE-III) to define the cognitive status.
The power analysis for the selection of the sample size for the postoperative program in the change of the 6-Minute Walk Test (primary outcome) after the completion of the program, in the 8 weeks postoperatively, was performed for significance level α = 0.05 and power = 90%.The investigators' assumption for power analysis stands to find a difference of 50 meters between the groups. Considering that the ratio between the groups will be 1: 1, the required sample size is 96 patients (48 in each group). Adding a drop-out rate of 20%, required sample size is defined in 116 patients (58 in each group). About the other primary outcome (postoperative 3-day Cumulated Ambulation Score - CAS), the investigators' power analysis revealed a required sample size of 80 patients, based on the assumptions of 2.4 points difference between the groups, α = 0.05 and power = 90%. In statistical analysis, only patients who completed at least a 3 days of preoperative program will be included.
- Conditions
- Hip Fractures
- Being tested
- Upper Extremity Aerobic Exercise
- Keywords
- hip fracture, exercise therapy, surgical stress, haemostasis, basic mobility
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity Aerobic ExerciseOther
Using a cycle-ergometer (Monark 881E)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise (Moderate-Intensity Interval Training) | Experimental | Preoperative program: 120 seconds of moderate intensity exercise (64-76% HRmax, 12-13 in rate of perceived exertion (RPE), based on ACSM) and 120 seconds of passive rest in a total of 4 cycles. The basic program will last about 14 minutes, plus 6 minutes for warm-up and recovery. The program will be performed twice a day.
Postoperative program: 120 seconds of moderate intensity exercise (64-76% HRmax, 12-13 in RPE, based on ACSM) and 120 seconds of passive rest in a total of 8 cycles. The basic program will last about 30 minutes, plus 6 minutes for warm-up and recovery. The program will be performed 3 times a week for a total of 8 weeks. Receives: Other: Upper Extremity Aerobic Exercise |
| Control | No intervention | Preoperatively: mild intensity activities focusing on memory and attention performing with upper limb movements using the interactive platform Kinems. The program will last about 20 minutes. To ensure that the intensity of activities is mild, there will be a simultaneous recording of heart rate, while at the end of each session the RPE scale will be evaluated. Postoperatively: none |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated Ambulation Score
The Cumulated Ambulation Score (CAS) is a reliable and valid instrument for assessing patients' basic mobility (getting in and out of bed, sit-to-stand from a chair, and walking), in orthopaedic wards. The minimum value is 0 and maximum 3 per day. The total 3-day CAS has a better prognostic value than the 1-day CAS, and is based on the sum score of the first three post-operative days, with a minimum value being 0 and maximum 9, for the total 3-day CAS, with a higher score means better outcome.
Measured: Total 3-day Cumulated Ambulation Score post-operatively.
Six Minute Walk Test (6MWT)
The 6MWT is a sub-maximal exercise test that is used to determine aerobic capacity and endurance.
Measured: 8 weeks post-operatively
Secondary outcomes (20)
Cumulated Ambulation Score
The Cumulated Ambulation Score (CAS) is a reliable and valid instrument for assessing patients' basic mobility (getting in and out of bed, sit-to-stand from a chair, and walking), in orthopaedic wards. Higher score means a better outcome.
Measured: 4 weeks post-operatively
Six Minute Walk Test (6MWT)
The 6MWT is a sub-maximal exercise test that is used to determine aerobic capacity and endurance.
Measured: 4, 26 & 52 weeks post-operatively
Timed-Up & Go
The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that assess mobility and balance impairments in older adults. Patients wear their usual shoes and, if necessary, can utilize a walking assistance. Begin by having the patient sit back in a normal armchair and drawing a line on the floor 3 meters (10 feet) away.
Measured: 4, 8, 26 & 52 weeks post-operatively
Modified Harris Hip Score
The modified Harris Hip Score (mHHS) is a reliable and valid self-reported questionnaire assessing hip pain and functionality. One question evaluates pain (score from 0-44) and 7 questions functionality (score from 0-47). The overall score is multiplied by 1.1 leading to a possible score of 0 to 100, with 100 being the best possible score for hip pain and function.
Measured: At admission (for pre-operative status) and 4, 8, 26 & 52 weeks post-operatively (for current status)
Lower Extremity Functional Scale
The Lower Extremtiy Functional Scale (LEFS) is a reliable and valid self-reported questionnaire assessing lower extremity function. The LEFS consists of 20 questions, evaluated on a 5-point scale (0-4˙ 0 = extremely high degree of difficulty, 4 = no difficulty, with a total score up to 80 degrees).
Measured: At admission (for pre-operative status) and 4, 8, 26 & 52 weeks post-operatively (for current status)
Lactate levels
Capillary blood with Lactate Scout+
Measured: Day 0 (at admission), Intraoperatively (at the beginning, 30 minutes later, and at the end of the surgery), & 12h postoperatively
Albumin levels
Measured: First day of admission, one day before surgery, 3 days, 4, 8, 26 & 52 weeks post-operatively
Tissue plasminogen activator
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Plasminogen activator inhibitor-1
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Thrombin-Antithrombin Complex
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Endogenous Thrombin Potential
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Fibrinogen plasma levels
The fibrinogen normal range is 200 to 400 mg/dL (2.0 to 4.0 g/L). Determination of fibrinogen plasma concentrations will be made performing a modification of the Clauss method with Fibrinogen Multifibren U reagent (Siemens Healthcare Diagnostics, Marburg, Germany). Fibrinogen increased levels are significantly associated with inflammatory markers, disease severity and thrombotic tendency.
The effect of the pre-operative and post-operative aerobic exercise on this variable and its association with clinical outcome will be assessed.
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
D-Dimers plasma levels
The reference concentration of D-dimer is < 250 ng/mL. D-dimers were assessed by the INNOVANCE D-Dimer assay (Siemens Healthcare Diagnostics, Marburg, Germany), a particle-enhanced immunoturbidimetric method. Besides the value of normal D-dimer measurements in allowing exclusion of venous thromboembolism (VTE) or pulmonary embolism (PE), D-dimer test also helps clinicians to stratify patients with the risk for deep venous thrombosis (DVT), since high levels of D-dimer in blood are associated with a major clot. That's why increased D-Dimer levels are considered as a marker of hemostatic imbalance.
The effect of the pre-operative aerobic and post-operative exercise on this variable and its association with clinical outcome will be assessed.
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Thrombomodulin plasma levels
Thrombomodulin (TM)levels range from 3 to 300 ng/ml. with normal levels fluctuating between 3.1 ± 1.3 ng/ml. A TM sandwich ELISA double antibody kit will be used for the measurements. TM, which is predominantly expressed on the endothelium, plays an important role in maintaining vascular homeostasis by regulating the coagulation system. During the hypercoagulable state after endothelial injury, TM is released into the intravascular space, thus reflecting derangements of hemostatic balance due to endothelial dysfunction. Moreover, TM reduces blood coagulation by converting thrombin to an anticoagulant enzyme from a procoagulant enzyme, while it has the potential to regulate intravascular injury via pleiotropic effects.
The effect of the pre-operative and post-operative aerobic exercise on this variable and its association with clinical outcome will be assessed.
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
von Willebrand factor (VWF); VWF:Antigen and VWF:Activity plasma levels
VWF:Antigen(Ag) and VWF:Activity(Ac) are used as markers of Platelet and Endothelial Dysfunction affecting hemostatic balance. VWF:Ag and VWF:Ac plasma levels will be determined by an automated latex enhanced immunoassay (HaemosIL™ assay, Instrumentation Laboratory Company, Lexington, KY, USA) on IL (Instrumentation Laboratory) coagulation systems (ACL TOP). VWF:Ac will be assessed by measuring the variations in turbidity generated by the agglutination of the latex reagent. An anti-VWF monoclonal antibody adsorbed onto the latex reagent reacts with the VWF of the blood sample. Agglutination is proportional to VWF:Ac and is calculated by the diminished light transmission caused by the aggregates. Results are presented as percentage of normality.
The effect of the pre-operative and post-operative aerobic exercise on this variable and its association with clinical outcome will be assessed.
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Haemostatic profile using ROTEM
Measured: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Transfusion requirements (litre)
Measured: Post-operative day 1, 2 and 3
Deep vein thrombosis & Pulmonary embolism (DVT & PE)
Number of every thromboembolic event
Measured: 4, 8, 26 & 52 weeks post-operatively
Re-admission
Re-admission rate for any reason
Measured: 4, 8, 26 & 52 weeks post-operatively
All-cause mortality
Measured: 4, 8, 26 & 52 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Koulouvaris, National and Kapodistrian University of Athens
- Investigators
- Panagiotis Koulouvaris, MD, Principal investigator, 1st Department of Orthopaedic Surgery, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389800
- Sponsor's protocol ID
- 402/26-7-2021
- Status last verified
- Mar 2024
- First submitted
- 8 Oct 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of this study will be available from the corresponding author, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Post-Operative Effects of Upper Extremity Aerobic Exercise in Mobility, Haemostatic Balance, and Mortality- and Morbidity-related Biomarkers in Hip Fracture Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05389800
- Acronym / sponsor ID
- 402/26-7-2021
- Conditions
- Hip Fractures
- Keywords
- hip fracture, exercise therapy, surgical stress, haemostasis, basic mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 May 2022 (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 purposes of this study are to determine the benefits of a pre-operative aerobic exercise program and an 8-week postoperative aerobic exercise program with a portable upper extremity cycle-ergometer in patients with hip fracture.
Detailed description
Hip fracture is one of the primary causes of significant morbidity in those over than 65 years old. Hip fracture is also among the top ten causes of loss of disability-adjusted life years in elderly. For the year 2020, in terms of the percentage of population over 80 years, Greece was second among the countries of the European Union, with this age group constituting 7.2% of its total population. In Greece, between 1977 and 2007, hip fractures doubled, with the annual impact rising to 343.96 per 100,000 inhabitants. For this population, a critical part of management is physical activity and exercise prescription both to prevent complications and to enhance rehabilitation after surgery. Postoperative (post-discharge) aerobic exercise programs of moderate intensity have already been used in patients with hip fracture proving its safety and positive effect in a variety of outcomes, such as aerobic capacity and quality of life. It is well established that these patients do not meet the minimum least amount of activity that should be done per week, based on Guidelines for Physical Activity by the World Health Organization neither during their hospitalization nor during their later life in the community. Also, although most Clinical Guidelines recommend a surgical management within 48 hours after hip trauma, there are many patient and system factors which can contribute to delayed surgery, such as surgical readiness, available resources, prioritisation and out-of-hours admission.
In terms of pre-operative exercise program, the investigators hypothesize that it will reduce surgical stress through the body's better response to lactate accumulation and the acute physiological effects on the patient's hematopoietic activity and hemostatic profile. Moderate intensity exercise will reduce platelet hyperactivity, increase fibrinolytic activity and reduce coagulation factors. In this more favorable environment, the immediate postoperative recovery of basic mobility can be accelerated. Regarding the post-operative exercise program, the investigators hypothesize that it will improve the independence and function of the lower extremity by increasing the cardiopulmonary capacity, while the improvement of the nutritional factors (albumin and pre-albumin) through the post-training protein synthesis will also contribute to this.
Apart from primary and secondary outcomes, at baseline the investigators will also evaluate the following: demographics; characteristics about the fracture and upcoming surgery, such as the type of fracture and the surgical procedure; New Mobility Score (NMS) to define the prefracture functional level; Addenbrooke's Cognitive Examination - III (ACE-III) to define the cognitive status.
The power analysis for the selection of the sample size for the postoperative program in the change of the 6-Minute Walk Test (primary outcome) after the completion of the program, in the 8 weeks postoperatively, was performed for significance level α = 0.05 and power = 90%.The investigators' assumption for power analysis stands to find a difference of 50 meters between the groups. Considering that the ratio between the groups will be 1: 1, the required sample size is 96 patients (48 in each group). Adding a drop-out rate of 20%, required sample size is defined in 116 patients (58 in each group). About the other primary outcome (postoperative 3-day Cumulated Ambulation Score - CAS), the investigators' power analysis revealed a required sample size of 80 patients, based on the assumptions of 2.4 points difference between the groups, α = 0.05 and power = 90%. In statistical analysis, only patients who completed at least a 3 days of preoperative program will be included.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise (Moderate-Intensity Interval Training) | Experimental | Other: Upper Extremity Aerobic ExercisePreoperative program: 120 seconds of moderate intensity exercise (64-76% HRmax, 12-13 in rate of perceived exertion (RPE), based on ACSM) and 120 seconds of passive rest in a total of 4 cycles. The basic program will last about 14 minutes, plus 6 minutes for warm-up and recovery. The program will be performed twice a day. Postoperative program: 120 seconds of moderate intensity exercise (64-76% HRmax, 12-13 in RPE, based on ACSM) and 120 seconds of passive rest in a total of 8 cycles. The basic program will last about 30 minutes, plus 6 minutes for warm-up and recovery. The program will be performed 3 times a week for a total of 8 weeks. |
| Control | No intervention | –Preoperatively: mild intensity activities focusing on memory and attention performing with upper limb movements using the interactive platform Kinems. The program will last about 20 minutes. To ensure that the intensity of activities is mild, there will be a simultaneous recording of heart rate, while at the end of each session the RPE scale will be evaluated. Postoperatively: none |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age: 65 years old and older
- Unilateral proximal femoral fracture/hip fracture (intertrochanteric or neck fracture)
- Ambulatory patients before fracture (with or without aid assistance)
- Agreed to participate and signed consent form
Key exclusion criteria (10 listed)
- Pathological fractures (under musculoskeletal oncology)
- Severe neuropsychiatric disorder (eg severe psychiatric disorder, dementia, etc.) to the extent that the researcher deems the patient incompetent or likely unable to remain compliant with the follow-up
- Unable to implement the exercise program due to underlying pathology or disability in the upper extremities
- More than one fracture
- Severe and / or unstable cardiovascular disease [e.g. congenital heart disease, uncontrolled severe hypertension (systolic blood pressure ≥ 180 mmHg and / or diastolic blood pressure ≥ 120 mmHg), unstable angina]
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 |
|---|---|---|
| Upper Extremity Aerobic ExerciseUsing a cycle-ergometer (Monark 881E) | Other | Aerobic Exercise (Moderate-Intensity Interval Training) |
Primary outcome
Cumulated Ambulation Score
Time frame: Total 3-day Cumulated Ambulation Score post-operatively.
The Cumulated Ambulation Score (CAS) is a reliable and valid instrument for assessing patients' basic mobility (getting in and out of bed, sit-to-stand from a chair, and walking), in orthopaedic wards. The minimum value is 0 and maximum 3 per day. The total 3-day CAS has a better prognostic value than the 1-day CAS, and is based on the sum score of the first three post-operative days, with a minimum value being 0 and maximum 9, for the total 3-day CAS, with a higher score means better outcome.
Six Minute Walk Test (6MWT)
Time frame: 8 weeks post-operatively
The 6MWT is a sub-maximal exercise test that is used to determine aerobic capacity and endurance.
20 secondary outcomes
Cumulated Ambulation Score
Time frame: 4 weeks post-operatively
Six Minute Walk Test (6MWT)
Time frame: 4, 26 & 52 weeks post-operatively
Timed-Up & Go
Time frame: 4, 8, 26 & 52 weeks post-operatively
Modified Harris Hip Score
Time frame: At admission (for pre-operative status) and 4, 8, 26 & 52 weeks post-operatively (for current status)
Lower Extremity Functional Scale
Time frame: At admission (for pre-operative status) and 4, 8, 26 & 52 weeks post-operatively (for current status)
Lactate levels
Time frame: Day 0 (at admission), Intraoperatively (at the beginning, 30 minutes later, and at the end of the surgery), & 12h postoperatively
Albumin levels
Time frame: First day of admission, one day before surgery, 3 days, 4, 8, 26 & 52 weeks post-operatively
Tissue plasminogen activator
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Plasminogen activator inhibitor-1
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Thrombin-Antithrombin Complex
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Endogenous Thrombin Potential
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Fibrinogen plasma levels
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
D-Dimers plasma levels
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Thrombomodulin plasma levels
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
von Willebrand factor (VWF); VWF:Antigen and VWF:Activity plasma levels
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Haemostatic profile using ROTEM
Time frame: First day of admission, one day before surgery, 3 days, 1, 4, 8, 26 & 52 weeks post-operatively
Transfusion requirements (litre)
Time frame: Post-operative day 1, 2 and 3
Deep vein thrombosis & Pulmonary embolism (DVT & PE)
Time frame: 4, 8, 26 & 52 weeks post-operatively
Re-admission
Time frame: 4, 8, 26 & 52 weeks post-operatively
All-cause mortality
Time frame: 4, 8, 26 & 52 weeks post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Yes. The data of this study will be available from the corresponding author, upon reasonable request.
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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.
Panagiotis Koulouvaris, MD principal investigator
1st Department of Orthopaedic Surgery, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Aerobic Exercise in people with Hip Fractures, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 4 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 21 Mar 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 Greece. 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 Panagiotis Koulouvaris, MD (+30 6947124919, info@drkoulouvaris.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulated Ambulation Score (time frame: Total 3-day Cumulated Ambulation Score post-operatively.). The study lists 2 primary outcomes in all. 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 21 Mar 2024.