Frail Elderly SyndromeTRAiltyNCT03964363
Home-based Prehabilitation for Elderly Patients
A study testing Unsupervised home-based physical prehabilitation in people with Frail Elderly Syndrome, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
Trial summary
As a consequence of the increasing life expectancy hospitals are seeing a growing number of elderly patients undergoing elective surgery. These patients are likely to suffer from one or more chronic illnesses, malnutrition, reduced physical strength and mobility and sensory impairment. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Unsupervised home-based physical prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 3 sitesGermany
- Study dates
- 29 May 2019to 30 Jan 2026
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- pre-frail or frail according to (Longitudinal Urban Cohort Ageing Study) LUCAS-functional index
- scheduled for elective surgery
- planned ward admission for at least 24h after surgery
Who cannot join
- Refusal of participation
- Presentation less than 2 weeks prior to scheduled procedure
- Pre-existing pronounced immobility (wheelchair bound, paresis of both arms or both legs)
- Minor surgical interventions such as small excisions of superficial tissues, small interventions for haemorrhoids, curettage, gastroscopy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Medical Center Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20247
Agaplesion Diakonieklinikum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20259
Rotkreuzklinikium München
München, Bavaria, 80634
About this study
Official title: Pre-operative Physical Training for Elderly Patients With Frailty
As a consequence of the increasing life expectancy hospitals are seeing a growing number of elderly patients undergoing elective surgery. These patients are likely to suffer from one or more chronic illnesses, malnutrition, reduced physical strength and mobility and sensory impairment. Age related loss of resilience in combination with these conditions often results in frailty. Frailty syndrome describes a reduction in weight, mobility and strength, as well as declining cognitive capacities and reduced performance in daily life activities. This decline in constitution is accompanied by an increased risk of complications and mortality in the period after surgery. Frail patients are generally admitted to hospital for a longer period and are readmitted more often.
A multitude of studies has demonstrated that these risks can be significantly reduced by offering frail patients a prevention program prior to their surgery. These prevention programs are often referred to as prehabilitation and combine strength and cardiovascular training with breathing exercises. Despite the obvious benefits, prehabilitation programs are not yet commonly applied outside of research settings as they carry considerable costs and required additional skilled personnel.
In response to the unmet need for a widely applicable, cost and personnel efficient prehabilitation program a home-based prehabilitation program has been designed. This prehabilitation allows patients to safely perform an individualised set of exercises without relying on a personal trainer or a training group. Efficiency and feasibility will be evaluated in this study.
Read the detailed description
The average age of hospital patients has steadily increased with the demographic change of Germany's ageing population. In 2014, more than 27 million people living in Germany were older than 60 years and more than one third of this group had to undergo surgery within that year.
A relevant proportion of this patient group has to be considered frail or pre-frail. Over a lifetime every individual experiences a physiological reduction of functional capacity across all organ systems resulting in frailty. Consequently, physical and psychological stress, such as a hospital stay and surgery cannot be readily compensated. Therefore, frailty is a highly predictive pre-operative risk factor for increased post-operative morbidly and mortality, prolonged hospital stay and loss of independence. Multiple studies have demonstrated post-operative outcome of frail patients can be drastically improved if these patients are identified prior to elective surgery and enrolled in a multimodal prehabilitation program. The core of prehabilitation is physical exercise next to nutritional and psychological support. The improvement of cardiovascular condition, ventilator capacity and muscle strength gained during prehabilitation resulted in a reduced incidence of complications including pneumonia, shorter hospital stays and improved quality of life. Yet despite these benefits prehabilitation is not yet widely available outside of clinical studies as they carry considerable costs and demand additional skilled personnel.
In order to provide prehabilitation to a larger group of patients, a pre-operative exercise program was developed, that can safely be followed by pre-frail and frail patients at home without the need of continuous instruction and supervision by a trainer or physiotherapist. Efficacy and feasibility will be evaluated in this study.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Unsupervised home-based physical prehabilitation
- Keywords
- Frailty, preoperative period, surgery, breathing exercise, postoperative complications, resistance training, endurance training, anaesthesia, activities of daily living, patient reported outcome, prehabilitation, perioperative care, elderly, prevention
- Medical subject headings
- Frailty, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsupervised home-based physical prehabilitationBehavioural
Subsequent to screening and initial testing for frailty syndrome, participants receive an information booklet containing a selection of exercises, which allows independent prehabilitation at home.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Participants are scheduled for elective surgery and follow the home-based prehabilitation for 11-17 days Receives: Behavioral: Unsupervised home-based physical prehabilitation |
| Prehabilitation + TAVI | Experimental | Study participants who will undergo a TAVI form a subgroup with a modified enrolment procedure and longer duration of the intervention. The prehabilitation period is extended to 30 days. Receives: Behavioral: Unsupervised home-based physical prehabilitation |
| Control | No intervention | Participants are initially evaluated for frailty prior to scheduled surgery but subsequently receive regular care without a prehabilitation program. All pre- and postsurgical evaluations will be identical to the prehabilitation group. |
| Control+TAVI | No intervention | The subgroup of participants who undergo a TAVI will be compared to a group of patients who will have had the same procedure. Hence the control group will also receive a screening via phone but then receive regular care. Follow-up after surgery will be identical in all groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery: QoR-15
The quality of recovery after surgery and anaesthesia is measured using the QoR-15 questionnaire. The resulting score indicates self-reported patent well-being and perceived support with higher scores (0-100) indicating a better quality of recovery. (8)
Measured: 7 days postoperative
Secondary outcomes (8)
Quality of recovery: QoR-15
The quality of recovery after surgery and anaesthesia is measured using the QoR-15 questionnaire. The resulting score indicates self-reported patent well-being and perceived support with higher scores (0-100) indicating a better quality of recovery. (8)
Measured: 3 months postoperative
Health related quality of life: Questionnaire Short Form-12 (SF-12)
The World Health Organisation Disability Assessment Schedule (WHODAS) assesses six domains of functioning relating to the quality of life. Quality of life is measured using the Questionnaire Short Form-12 (SF-12), which indicates physical and psychological wellbeing. Higher scores indicate a better health related quality of life.
Measured: preoperative, 3 months postoperative
Activities of daily living
The Lawton-Brody Instrumental Activities of Daily Living is used to assess the ability to perform activities that are central to living independently. A lower score indicates better functioning. The score ranges between 8 - 31
Measured: preoperative, 7 days and 3 months postoperative
Cognitive performance
Cognitive functioning will be tested with the Montreal Cognitive assessment (MOCA), a standardised test that includes memory recall, verbal fluency and visuospatial abilities. A total score between 0 and 30 is calculated with a higher score indicating better cognitive functioning.
Measured: preoperative, 7 days and 3 months postoperative
Mobility
The time up\&go-test, in which the subject starts from a sitting position, walks a defined distance of 3 m and returns to a sitting position on a chair is indicative of fall risk and mobility. The chosen cut-off in this study is 10 seconds.
Measured: preoperative, 3 months postoperative
Muscle strength
Grip strength is widely used in the diagnosis of frailty and sarcopenia. It will be measured with a hand held dynamometer in kg, using the dominant hand if possible.
Measured: preoperative, 7 days postoperative
Incidence of postoperative complications
Complications reported in hospital files or patient interview
Measured: preoperative, 7 days and 3 months postoperative
Duration of hospital admission
Day of admission to day of discharge
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start29 May 2019
- Primary completion15 Sep 2024
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trail is designed as a prospective, multicentre, randomized controlled study with two parallel groups with a total of four arms. Patients with a scheduled elective surgery will be randomly assigned into treatment and control group after having been screened for frailty. A subgroup will be formed by patients who will receive a transcatheter aortic valve implantation (TAVI). The preventative effect of a behaviour modification will subsequently be compared.
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Olotu, MD, Principal investigator, Department of Anaesthesiology, University Medical Center Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964363
- Sponsor's protocol ID
- PV5951
- Acronym
- TRAilty
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2019
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SW, Han HS, Jung HW, Kim KI, Hwang DW, Kang SB, Kim CH. Multidimensional frailty score for the prediction of postoperative mortality risk. JAMA Surg. 2014 Jul;149(7):633-40. doi: 10.1001/jamasurg.2014.241.
PubMed 24804971Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
PubMed 20510798Jadczak AD, Makwana N, Luscombe-Marsh N, Visvanathan R, Schultz TJ. Effectiveness of exercise interventions on physical function in community-dwelling frail older people: an umbrella review of systematic reviews. JBI Database System Rev Implement Rep. 2018 Mar;16(3):752-775. doi: 10.11124/JBISRIR-2017-003551.
PubMed 29521871Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.
PubMed 29367198Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.
PubMed 25420470Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PubMed 25058504
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Physical Training for Elderly Patients With Frailty
- ClinicalTrials.gov ID
- NCT03964363
- Acronym / sponsor ID
- TRAilty / PV5951
- Conditions
- Frail Elderly Syndrome
- Keywords
- Frailty, preoperative period, surgery, breathing exercise, postoperative complications, resistance training, endurance training, anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 28 May 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.
As a consequence of the increasing life expectancy hospitals are seeing a growing number of elderly patients undergoing elective surgery. These patients are likely to suffer from one or more chronic illnesses, malnutrition, reduced physical strength and mobility and sensory impairment. Age related loss of resilience in combination with these conditions often results in frailty. Frailty syndrome describes a reduction in weight, mobility and strength, as well as declining cognitive capacities and reduced performance in daily life activities. This decline in constitution is accompanied by an increased risk of complications and mortality in the period after surgery. Frail patients are generally admitted to hospital for a longer period and are readmitted more often.
A multitude of studies has demonstrated that these risks can be significantly reduced by offering frail patients a prevention program prior to their surgery. These prevention programs are often referred to as prehabilitation and combine strength and cardiovascular training with breathing exercises. Despite the obvious benefits, prehabilitation programs are not yet commonly applied outside of research settings as they carry considerable costs and required additional skilled personnel.
In response to the unmet need for a widely applicable, cost and personnel efficient prehabilitation program a home-based prehabilitation program has been designed. This prehabilitation allows patients to safely perform an individualised set of exercises without relying on a personal trainer or a training group. Efficiency and feasibility will be evaluated in this study.
Detailed description
The average age of hospital patients has steadily increased with the demographic change of Germany's ageing population. In 2014, more than 27 million people living in Germany were older than 60 years and more than one third of this group had to undergo surgery within that year.
A relevant proportion of this patient group has to be considered frail or pre-frail. Over a lifetime every individual experiences a physiological reduction of functional capacity across all organ systems resulting in frailty. Consequently, physical and psychological stress, such as a hospital stay and surgery cannot be readily compensated. Therefore, frailty is a highly predictive pre-operative risk factor for increased post-operative morbidly and mortality, prolonged hospital stay and loss of independence. Multiple studies have demonstrated post-operative outcome of frail patients can be drastically improved if these patients are identified prior to elective surgery and enrolled in a multimodal prehabilitation program. The core of prehabilitation is physical exercise next to nutritional and psychological support. The improvement of cardiovascular condition, ventilator capacity and muscle strength gained during prehabilitation resulted in a reduced incidence of complications including pneumonia, shorter hospital stays and improved quality of life. Yet despite these benefits prehabilitation is not yet widely available outside of clinical studies as they carry considerable costs and demand additional skilled personnel.
In order to provide prehabilitation to a larger group of patients, a pre-operative exercise program was developed, that can safely be followed by pre-frail and frail patients at home without the need of continuous instruction and supervision by a trainer or physiotherapist. Efficacy and feasibility will be evaluated in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This trail is designed as a prospective, multicentre, randomized controlled study with two parallel groups with a total of four arms. Patients with a scheduled elective surgery will be randomly assigned into treatment and control group after having been screened for frailty. A subgroup will be formed by patients who will receive a transcatheter aortic valve implantation (TAVI). The preventative effect of a behaviour modification will subsequently be compared.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Unsupervised home-based physical prehabilitationParticipants are scheduled for elective surgery and follow the home-based prehabilitation for 11-17 days |
| Prehabilitation + TAVI | Experimental | Behavioral: Unsupervised home-based physical prehabilitationStudy participants who will undergo a TAVI form a subgroup with a modified enrolment procedure and longer duration of the intervention. The prehabilitation period is extended to 30 days. |
| Control | No intervention | –Participants are initially evaluated for frailty prior to scheduled surgery but subsequently receive regular care without a prehabilitation program. All pre- and postsurgical evaluations will be identical to the prehabilitation group. |
| Control+TAVI | No intervention | –The subgroup of participants who undergo a TAVI will be compared to a group of patients who will have had the same procedure. Hence the control group will also receive a screening via phone but then receive regular care. Follow-up after surgery will be identical in all groups. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- pre-frail or frail according to (Longitudinal Urban Cohort Ageing Study) LUCAS-functional index
- scheduled for elective surgery
- planned ward admission for at least 24h after surgery
Key exclusion criteria (4 listed)
- Refusal of participation
- Presentation less than 2 weeks prior to scheduled procedure
- Pre-existing pronounced immobility (wheelchair bound, paresis of both arms or both legs)
- Minor surgical interventions such as small excisions of superficial tissues, small interventions for haemorrhoids, curettage, gastroscopy
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 |
|---|---|---|
| Unsupervised home-based physical prehabilitationSubsequent to screening and initial testing for frailty syndrome, participants receive an information booklet containing a selection of exercises, which allows independent prehabilitation at home. | Behavioural | Prehabilitation, Prehabilitation + TAVI |
Primary outcome
Quality of recovery: QoR-15
Time frame: 7 days postoperative
The quality of recovery after surgery and anaesthesia is measured using the QoR-15 questionnaire. The resulting score indicates self-reported patent well-being and perceived support with higher scores (0-100) indicating a better quality of recovery. (8)
8 secondary outcomes
Quality of recovery: QoR-15
Time frame: 3 months postoperative
Health related quality of life: Questionnaire Short Form-12 (SF-12)
Time frame: preoperative, 3 months postoperative
Activities of daily living
Time frame: preoperative, 7 days and 3 months postoperative
Cognitive performance
Time frame: preoperative, 7 days and 3 months postoperative
Mobility
Time frame: preoperative, 3 months postoperative
Muscle strength
Time frame: preoperative, 7 days postoperative
Incidence of postoperative complications
Time frame: preoperative, 7 days and 3 months postoperative
Duration of hospital admission
Time frame: 3 months 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 22 Jul 2026.
- Background: PubMed 24804971Kim SW, Han HS, Jung HW, Kim KI, Hwang DW, Kang SB, Kim CH. Multidimensional frailty score for the prediction of postoperative mortality risk. JAMA Surg. 2014 Jul;149(7):633-40. doi: 10.1001/jamasurg.2014.241.
- Background: PubMed 20510798Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- Background: PubMed 29521871Jadczak AD, Makwana N, Luscombe-Marsh N, Visvanathan R, Schultz TJ. Effectiveness of exercise interventions on physical function in community-dwelling frail older people: an umbrella review of systematic reviews. JBI Database System Rev Implement Rep. 2018 Mar;16(3):752-775. doi: 10.11124/JBISRIR-2017-003551.
- Background: PubMed 29367198Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.
- Background: PubMed 25420470Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.
- Background: PubMed 16129869Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Background: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Background: PubMed 25058504Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Olotu, MD principal investigator
Department of Anaesthesiology, University Medical Center Eppendorf
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unsupervised home-based physical prehabilitation in people with Frail Elderly Syndrome, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.
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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. 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 Germany. 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?
Quality of recovery: QoR-15 (time frame: 7 days 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 NCT03964363, which also lists 8 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 22 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.