Postoperative CareNCT03357497
Very Early Mobilization of Colorectal Surgery Patients
A study testing Very early mobilization in people with Postoperative Care and Colorectal Surgery, run by Region Örebro County at 1 site in Sweden.
Trial summary
Early mobilization is an important part of Enhanced Recovery Programs (ERP)in colorectal surgery. The aim of this randomized controlled trial is to investigate the impact of very early mobilization, starting within 1 hour after surgery, on further mobilization within an existing Enhanced Recovery Program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care, Colorectal Surgery
- What is being tested?
- Very early mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2017to 30 May 2019
- 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
- All patients over the age of 18 scheduled for colorectal surgery
Who cannot join
- Unable to understand study information (language,cognitive impairment, etc.)
- Unable to walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Very Early Mobilization of Colorectal Surgery Patients - A Randomized Controlled Trial
Early mobilization is an important part of Enhanced Recovery Programs (ERP)in colorectal surgery. The aim of this randomized controlled trial is to investigate the impact of very early mobilization, starting within 1 hour after surgery, on further mobilization within an existing Enhanced Recovery Program.
Read the detailed description
Post-operative bed rest and immobility has a negative effect on morbidity and mortality after colorectal surgery.To prevent immobilization early mobilization is a well established part of Enhanced Recovery Programs. This facility uses protocols developed by the ERAS (Enhanced Recovery After Surgery)-society. However not all patients can reach the level physical activity needed to be in compliance with the ERP. This being more frequent in the elderly frail patient. This may contribute to longer hospital stay and increase the risk of complications. The aim of this trial is to investigate if a very early mobilization intervention will lead to a higher lever of physical activity after surgery compared with standard-care.
The aim is to include 150 patients scheduled to undergo colorectal surgery. Patients will receive written and verbal information about the trial before written consent is obtained. The patients will undergo an extended pre-operative assessment during which a baseline for patients physical activity level will be established before surgery. For this purpose the patients will be evaluated by a physiotherapist with the following tools; 6-minutes walk test, Timed up and go-test (TUG), mini modified Functional Independence Measure (mFIM), WHO disability assessment score (WHODAS) and activity measurement with accelerometry for up to 7 days. (Actigraph GT3X device)
The randomization will take place on the day of the surgery and the patients will be assigned to either intervention (very early mobilization) or control group (standard post-operative care). A stratified randomization will be performed to ensure an even spread within three patient categories: Laparoscopic surgery, Open surgery and Rectum amputation. The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.
After surgery the patients will be transferred to the post-operative care unit where the patients included in the intervention group will be mobilized with the help of a physiotherapist and post-operative unit staff. The intervention will begin as early as 30 minutes after arrival in the post-operative unit. The intervention will follow the Surgical ICU Optimal Mobilization Score (SOMS) which includes four steps of mobilization from movement in bed up to walking. Progress from each step to the next will be conditioned with patient fulfilling criteria for a safe mobilization including stable physiological parameters and adequate pain situation. The patients in the standard care group will not receive the intervention.
All patients will receive information about early mobilization. The patients will not receive information on the timing of the mobilization intervention in an effort to remain blinded to the intervention. The patient in the standard care group will be mobilized accordingly to the ERP protocol, which also includes early mobilization in the surgical ward. Upon transfer from the post-operative unit to the surgical ward all study patients will be again fitted with the activity monitor to measure their physical activity during the post-operative phase.
During hospital stay all study patients will be subject to routine mobilization within the existing ERP protocol. To determine the physical activity level the patient will be wearing the activity monitoring device until discharge from the surgical ward. The study patients will also be evaluated by blinded physiotherapists with mFIM and 6 minutes walk-test. In addition information will be gathered regarding routine documentation on patient mobilization progress to measure adherence to ERP goals.
After four to six weeks the patients are scheduled for a standard post-operative follow-up visit. The study patients will then also meet a blinded physiotherapist that previously was not participating in the intervention who will repeat the following tests: 6 minutes walk-test, WHODAS, TUG. All study patients will also be instructed to wear the activity monitor for additional seven days to again measure their physical activity level. All patients who have undergone the intervention will be scheduled for a semi-structured telephone interview about their perception of the SOMS intervention.
Follow-up questionnaire with WHODAS self-reported questions will be gathered through a telephone interview with the patients three, six and twelve months after surgery.
- Conditions
- Postoperative Care, Colorectal Surgery
- Being tested
- Very early mobilization
- Keywords
- colorectal surgery, early mobilization, postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very early mobilizationOther
The patient will be mobilized by a physiotherapist in our postoperative care unit. The intervention uses the SOMS protocol.
| Study group | Role | What they receive |
|---|---|---|
| Very early mobilization | Experimental | This group will be mobilized in the post-operative unit by a designated physiotherapist. The intervention will be conducted accordingly with the SOMS protocol. Receives: Other: Very early mobilization |
| Standard post-operative care | No intervention | This group will receive standard post-operative care. Mobilization will only take place if the patient request it or to facilitate god post-operative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level measured with accelerometry
Comparison between intervention and standard-care group by measurements of physical activity level with an accelerometer that the patient wears during the day. The accelerometer is worn at hip level.
Measured: 72 hours
Secondary outcomes (15)
Time out of bed measured with a protocol
Comparison between intervention and standard-care group, analysis of time out of bed and thus compliance to ERP goals using written documentation in the surgical ward.
Measured: 7 days
Minutes in the postoperative ward
To ascertain if this intervention is cost effective by comparing time in the post-operative unit between intervention and standard care group.
Measured: one year
Days in the hospital ward
To ascertain if this intervention is cost effective by comparing total hospital stay time between intervention and standard care group.
Measured: one year
Number of adverse events during the SOMS intervention.
Frequency of adverse events during the intervention using the SOMS-protocol. Adverse events here are abnormal blood pressure, pulse, oxygen saturation %, respiratory rate, pain, presence of vertigo, presence of nausea and vomiting.
Measured: one day
Blood pressure during the SOMS intervention.
Blood pressure are registered during the intervention.
Measured: one day
Pulse during the SOMS intervention.
Number of heartbeats are registered during the intervention with a device on the patients finger.
Measured: one day
Oxygen saturation during the SOMS intervention.
Oxygen saturation are registered during the intervention with a device on the patients finger.
Measured: one day
Pain
Pain experienced by the patient during the SOMS intervention, rated using a Visual analogue scale 0-100.
Measured: one day
Presence of vertigo
Vertigo experienced by the patient during the SOMS intervention, presence rated as yes/no.
Measured: one day
Presence of nausea
Nausea experienced by the patient during the SOMS intervention, presence rated as yes/no. If patient vomits due to nausea is also rated yes/no.
Measured: one day
6 minute Walking test
Physical capacity measured with the 6 minute Walking test. The number of meters a patient walks during 6 minutes.
Measured: 6 weeks
Timed up and Go (TUG) test
Test of functional mobility. The patient sits on a chair, rises and walks 3 meters, turns och walks back and sits down on the chair. Time in seconds to perform the test.
Measured: 6 weeks
Patient perception of the SOMS intervention
Semi structured telephone interview with patients in the intervention group about their perception of the intervention.
Measured: 6 weeks
Severity of post-operative complications
Monitoring number and frequency of patient complications with review of patient records using Clavien-Dindo complication classification
Measured: one year
Self-perceived health and physical function level one year after surgery
Using the WHODAS questionnaire, self-reported
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start25 Sep 2017
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Ahlstrand, M.D. PhD, Principal investigator, Region Örebro länAnette Forsberg, PhD, Principal investigator, Region Örebro län
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357497
- Sponsor's protocol ID
- 230961
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2017
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harper CM, Lyles YM. Physiology and complications of bed rest. J Am Geriatr Soc. 1988 Nov;36(11):1047-54. doi: 10.1111/j.1532-5415.1988.tb04375.x.
PubMed 3049751Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
PubMed 23052794Smart NJ, White P, Allison AS, Ockrim JB, Kennedy RH, Francis NK. Deviation and failure of enhanced recovery after surgery following laparoscopic colorectal surgery: early prediction model. Colorectal Dis. 2012 Oct;14(10):e727-34. doi: 10.1111/j.1463-1318.2012.03096.x.
PubMed 22594524Castelino T, Fiore JF Jr, Niculiseanu P, Landry T, Augustin B, Feldman LS. The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. Surgery. 2016 Apr;159(4):991-1003. doi: 10.1016/j.surg.2015.11.029. Epub 2016 Jan 21.
PubMed 26804821Shulman MA, Myles PS, Chan MT, McIlroy DR, Wallace S, Ponsford J. Measurement of disability-free survival after surgery. Anesthesiology. 2015 Mar;122(3):524-36. doi: 10.1097/ALN.0000000000000586.
PubMed 25689757Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M. Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.
PubMed 23959756Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
PubMed 12890299Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.
PubMed 3503663Thorn RW, Stepniewski J, Hjelmqvist H, Forsberg A, Ahlstrand R, Ljungqvist O. Supervised Immediate Postoperative Mobilization After Elective Colorectal Surgery: A Feasibility Study. World J Surg. 2022 Jan;46(1):34-42. doi: 10.1007/s00268-021-06347-2. Epub 2021 Oct 19.
PubMed 34668047
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Early Mobilization of Colorectal Surgery Patients - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03357497
- Acronym / sponsor ID
- 230961
- Conditions
- Postoperative Care, Colorectal Surgery
- Keywords
- colorectal surgery, early mobilization, postoperative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early mobilization is an important part of Enhanced Recovery Programs (ERP)in colorectal surgery. The aim of this randomized controlled trial is to investigate the impact of very early mobilization, starting within 1 hour after surgery, on further mobilization within an existing Enhanced Recovery Program.
Detailed description
Post-operative bed rest and immobility has a negative effect on morbidity and mortality after colorectal surgery.To prevent immobilization early mobilization is a well established part of Enhanced Recovery Programs. This facility uses protocols developed by the ERAS (Enhanced Recovery After Surgery)-society. However not all patients can reach the level physical activity needed to be in compliance with the ERP. This being more frequent in the elderly frail patient. This may contribute to longer hospital stay and increase the risk of complications. The aim of this trial is to investigate if a very early mobilization intervention will lead to a higher lever of physical activity after surgery compared with standard-care.
The aim is to include 150 patients scheduled to undergo colorectal surgery. Patients will receive written and verbal information about the trial before written consent is obtained. The patients will undergo an extended pre-operative assessment during which a baseline for patients physical activity level will be established before surgery. For this purpose the patients will be evaluated by a physiotherapist with the following tools; 6-minutes walk test, Timed up and go-test (TUG), mini modified Functional Independence Measure (mFIM), WHO disability assessment score (WHODAS) and activity measurement with accelerometry for up to 7 days. (Actigraph GT3X device)
The randomization will take place on the day of the surgery and the patients will be assigned to either intervention (very early mobilization) or control group (standard post-operative care). A stratified randomization will be performed to ensure an even spread within three patient categories: Laparoscopic surgery, Open surgery and Rectum amputation. The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.
After surgery the patients will be transferred to the post-operative care unit where the patients included in the intervention group will be mobilized with the help of a physiotherapist and post-operative unit staff. The intervention will begin as early as 30 minutes after arrival in the post-operative unit. The intervention will follow the Surgical ICU Optimal Mobilization Score (SOMS) which includes four steps of mobilization from movement in bed up to walking. Progress from each step to the next will be conditioned with patient fulfilling criteria for a safe mobilization including stable physiological parameters and adequate pain situation. The patients in the standard care group will not receive the intervention.
All patients will receive information about early mobilization. The patients will not receive information on the timing of the mobilization intervention in an effort to remain blinded to the intervention. The patient in the standard care group will be mobilized accordingly to the ERP protocol, which also includes early mobilization in the surgical ward. Upon transfer from the post-operative unit to the surgical ward all study patients will be again fitted with the activity monitor to measure their physical activity during the post-operative phase.
During hospital stay all study patients will be subject to routine mobilization within the existing ERP protocol. To determine the physical activity level the patient will be wearing the activity monitoring device until discharge from the surgical ward. The study patients will also be evaluated by blinded physiotherapists with mFIM and 6 minutes walk-test. In addition information will be gathered regarding routine documentation on patient mobilization progress to measure adherence to ERP goals.
After four to six weeks the patients are scheduled for a standard post-operative follow-up visit. The study patients will then also meet a blinded physiotherapist that previously was not participating in the intervention who will repeat the following tests: 6 minutes walk-test, WHODAS, TUG. All study patients will also be instructed to wear the activity monitor for additional seven days to again measure their physical activity level. All patients who have undergone the intervention will be scheduled for a semi-structured telephone interview about their perception of the SOMS intervention.
Follow-up questionnaire with WHODAS self-reported questions will be gathered through a telephone interview with the patients three, six and twelve months after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very early mobilization | Experimental | Other: Very early mobilizationThis group will be mobilized in the post-operative unit by a designated physiotherapist. The intervention will be conducted accordingly with the SOMS protocol. |
| Standard post-operative care | No intervention | –This group will receive standard post-operative care. Mobilization will only take place if the patient request it or to facilitate god post-operative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 18 scheduled for colorectal surgery
Key exclusion criteria (2 listed)
- Unable to understand study information (language,cognitive impairment, etc.)
- Unable to walk
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 |
|---|---|---|
| Very early mobilizationThe patient will be mobilized by a physiotherapist in our postoperative care unit. The intervention uses the SOMS protocol. | Other | Very early mobilization |
Primary outcome
Physical activity level measured with accelerometry
Time frame: 72 hours
Comparison between intervention and standard-care group by measurements of physical activity level with an accelerometer that the patient wears during the day. The accelerometer is worn at hip level.
15 secondary outcomes
Time out of bed measured with a protocol
Time frame: 7 days
Minutes in the postoperative ward
Time frame: one year
Days in the hospital ward
Time frame: one year
Number of adverse events during the SOMS intervention.
Time frame: one day
Blood pressure during the SOMS intervention.
Time frame: one day
Pulse during the SOMS intervention.
Time frame: one day
Oxygen saturation during the SOMS intervention.
Time frame: one day
Pain
Time frame: one day
Presence of vertigo
Time frame: one day
Presence of nausea
Time frame: one day
6 minute Walking test
Time frame: 6 weeks
Timed up and Go (TUG) test
Time frame: 6 weeks
Patient perception of the SOMS intervention
Time frame: 6 weeks
Severity of post-operative complications
Time frame: one year
Self-perceived health and physical function level one year after surgery
Time frame: one year
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 7 Nov 2019.
- Background: PubMed 3049751Harper CM, Lyles YM. Physiology and complications of bed rest. J Am Geriatr Soc. 1988 Nov;36(11):1047-54. doi: 10.1111/j.1532-5415.1988.tb04375.x.
- Background: PubMed 23052794Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
- Background: PubMed 22594524Smart NJ, White P, Allison AS, Ockrim JB, Kennedy RH, Francis NK. Deviation and failure of enhanced recovery after surgery following laparoscopic colorectal surgery: early prediction model. Colorectal Dis. 2012 Oct;14(10):e727-34. doi: 10.1111/j.1463-1318.2012.03096.x.
- Background: PubMed 26804821Castelino T, Fiore JF Jr, Niculiseanu P, Landry T, Augustin B, Feldman LS. The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. Surgery. 2016 Apr;159(4):991-1003. doi: 10.1016/j.surg.2015.11.029. Epub 2016 Jan 21.
- Background: PubMed 25689757Shulman MA, Myles PS, Chan MT, McIlroy DR, Wallace S, Ponsford J. Measurement of disability-free survival after surgery. Anesthesiology. 2015 Mar;122(3):524-36. doi: 10.1097/ALN.0000000000000586.
- Background: PubMed 23959756Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M. Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.
- Background: PubMed 12890299Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.
- Background: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Background: PubMed 3503663Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.
- Derived from this study: PubMed 34668047Thorn RW, Stepniewski J, Hjelmqvist H, Forsberg A, Ahlstrand R, Ljungqvist O. Supervised Immediate Postoperative Mobilization After Elective Colorectal Surgery: A Feasibility Study. World J Surg. 2022 Jan;46(1):34-42. doi: 10.1007/s00268-021-06347-2. Epub 2021 Oct 19.
- 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.
Rebecca Ahlstrand, M.D. PhD principal investigator
Region Örebro län
Anette Forsberg, PhD principal investigator
Region Örebro län
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very early mobilization in people with Postoperative Care and Colorectal Surgery, run by Region Örebro County at 1 site in Sweden.
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 2 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 7 Nov 2019. 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 Sweden. 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?
Physical activity level measured with accelerometry (time frame: 72 hours). 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 NCT03357497, which also lists 10 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 7 Nov 2019.