Non-cardiac SurgeryPAMP-Phase2NCT03213496
Promotion of Ambulation Before Non-cardiac Surgery
A study testing Walk prescription and Conventional care in people with Non-cardiac Surgery, run by Fundación Cardioinfantil Instituto de Cardiología at 2 sites in Colombia.
Trial summary
Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to conventional intervention (not recommended exercise) in reducing the length of hospital stay and the time of onset of ambulation during postoperative hospitalization, in patients with ability to move, ≥30 years who will… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Non-cardiac Surgery
- What is being tested?
- Walk prescription and Conventional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 2 sitesColombia
- Study dates
- 1 May 2016to 31 Dec 2017
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing non-cardiac surgery
- general anesthesia or epidural or spinal anesthesia
- age ≥ 30 years
- able to walk and communicate
Who cannot join
- having any alteration of their state of consciousness
- altered mental status and communication
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Fundación CardioInfantil Instituto de Cardiología
Bogotá, Cundinamarca
Clinica Carlos Ardila Lulle-FOSCAL
Bucaramanga, Santander Department
About this study
Official title: Impact of a Routine of Pre-surgical Walk for Non Cardiac Adult Patients Compared to Conventional Intervention (Not Recommended Exercise) in Reducing the Length of Hospital Stay and the Time of Onset of Ambulation.
Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to conventional intervention (not recommended exercise) in reducing the length of hospital stay and the time of onset of ambulation during postoperative hospitalization, in patients with ability to move, ≥30 years who will undergo non-cardiac surgery.
Secondary
Read more
- Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during hospitalization.
- Evaluate the incidence of falls during hospitalization.
Methodology The PAMP project phase II, as a component of CARDIECOL program will be implemented by designing a pilot study, a randomized controlled trial. Adult-patients with greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed consent will be randomized to an intervention prescribed of walking in the period of 2-3 weeks before surgery or will be assigned to a Control group/conventional care. The study was not blinded to patients, but evaluation and analysis of the data will be blinded for researchers and statisticians. Patients will be evaluated on their previous level of physical activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise). This study will include a sample of 500 patients, with capacity to mobilize, ability to walk at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of stay, and time to first walk. Other results are evaluation falls during hospitalization and the presence of falls, report of cardiovascular events, and death by group.
Expected results
Read the detailed description
Randomization was planned to be performed one to five weeks before non-cardiac surgery for all eligible patients, once they have decided to participate in the study. It was performed on a random computed to an intervention group (Walk prescription); or conventional care group (no exercise) in a 2:1 relation respectively. Intervention and Management Processes The pre surgical intervention walk routine is defined of at least 150-300 minutes of walk before going into surgery.
Analysis will be following the principle of intention to treat. A description of categorical and quantitative demographic data will be performed. Evaluation will also include the mean difference in the length of hospital stay for each of the groups and standard deviation, given a confidence interval of 95%. An analysis of the time of occurrence of the first walk using the Kaplan-Meier estimator will be performed.
- Conditions
- Non-cardiac Surgery
- Being tested
- Walk prescription, Conventional care
- Keywords
- clinical trial, non cardiac surgery, walking.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk prescriptionBehavioural
Also called prehabilitation
30-40 minutes daily, for five days at the week, all weeks up to surgery.
Conventional careOther
Patient do not walk before surgery
| Study group | Role | What they receive |
|---|---|---|
| Walk prescription | Experimental | Walk prescription for all weeks before non-cardiac surgery. Duration of walk must be of 30-40 minutes every day for five days at the week or until complete 150 minutes at the week, for all weeks up to the surgery. Receives: Behavioral: Walk prescription |
| Conventional care | Other | Currently patients do not receive exercise (walk)-prescription before non cardiac surgery. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Total stay hours
Measured: Up 40 weeks in hospitalization
Secondary outcomes (3)
Falls
Fall event reported in patients´ charts
Measured: Up 40 weeks in hospitalization
Ischemic events
Myocardial infarction or stroke
Measured: Up 40 weeks in hospitalization
Time to the first walk
First time out of the bed registered in patients´charts
Measured: Up 40 weeks in hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 May 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-cardiac SurgeryStudies 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
- Model description
- Adult patients programmed for elective non-cardiac surgery, prior informed consent, will be randomized to an intervention (prescription of a programed walking) in the period of 2-3 weeks before surgery or will be assigned to a control group/conventional care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardioinfantil Instituto de Cardiología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Cortés, PI, Principal investigator, Fundación Cardioinfantil Instituto de Cardiología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213496
- Sponsor's protocol ID
- CEIC-2224-2015
- Acronym
- PAMP-Phase2
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be registered in indepenedent filles in folders; and also data will be typed on the PAMP Data base (CARDIECOL). Data can be monitored by a coordinator.
Publications
Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
PubMed 20602503Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966-9. doi: 10.1139/apnm-2015-0084. Epub 2015 May 13.
PubMed 26300015Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
PubMed 21878237Cortes OL, Herrera-Galindo M, Becerra C, Rincon-Roncancio M, Povea-Combariza C, Esparza-Bohorquez M. Preoperative walking recommendation for non-cardiac surgery patients to reduce the length of hospital stay: a randomized control trial. BMC Sports Sci Med Rehabil. 2021 Jul 28;13(1):80. doi: 10.1186/s13102-021-00317-w.
PubMed 34321092
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Routine of Pre-surgical Walk for Non Cardiac Adult Patients Compared to Conventional Intervention (Not Recommended Exercise) in Reducing the Length of Hospital Stay and the Time of Onset of Ambulation.
- ClinicalTrials.gov ID
- NCT03213496
- Acronym / sponsor ID
- PAMP-Phase2 / CEIC-2224-2015
- Conditions
- Non-cardiac Surgery
- Keywords
- clinical trial, non cardiac surgery, walking.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Fundación Cardioinfantil Instituto de CardiologíaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Jul 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.
Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to conventional intervention (not recommended exercise) in reducing the length of hospital stay and the time of onset of ambulation during postoperative hospitalization, in patients with ability to move, ≥30 years who will undergo non-cardiac surgery.
Secondary
- Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during hospitalization.
- Evaluate the incidence of falls during hospitalization.
Methodology The PAMP project phase II, as a component of CARDIECOL program will be implemented by designing a pilot study, a randomized controlled trial. Adult-patients with greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed consent will be randomized to an intervention prescribed of walking in the period of 2-3 weeks before surgery or will be assigned to a Control group/conventional care. The study was not blinded to patients, but evaluation and analysis of the data will be blinded for researchers and statisticians. Patients will be evaluated on their previous level of physical activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise). This study will include a sample of 500 patients, with capacity to mobilize, ability to walk at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of stay, and time to first walk. Other results are evaluation falls during hospitalization and the presence of falls, report of cardiovascular events, and death by group.
Expected results
Detailed description
Randomization was planned to be performed one to five weeks before non-cardiac surgery for all eligible patients, once they have decided to participate in the study. It was performed on a random computed to an intervention group (Walk prescription); or conventional care group (no exercise) in a 2:1 relation respectively. Intervention and Management Processes The pre surgical intervention walk routine is defined of at least 150-300 minutes of walk before going into surgery.
Analysis will be following the principle of intention to treat. A description of categorical and quantitative demographic data will be performed. Evaluation will also include the mean difference in the length of hospital stay for each of the groups and standard deviation, given a confidence interval of 95%. An analysis of the time of occurrence of the first walk using the Kaplan-Meier estimator will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Adult patients programmed for elective non-cardiac surgery, prior informed consent, will be randomized to an intervention (prescription of a programed walking) in the period of 2-3 weeks before surgery or will be assigned to a control group/conventional care.
| Arm | Type | Receives |
|---|---|---|
| Walk prescription | Experimental | Behavioral: Walk prescriptionWalk prescription for all weeks before non-cardiac surgery. Duration of walk must be of 30-40 minutes every day for five days at the week or until complete 150 minutes at the week, for all weeks up to the surgery. |
| Conventional care | Other | Other: Conventional careCurrently patients do not receive exercise (walk)-prescription before non cardiac surgery. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing non-cardiac surgery
- general anesthesia or epidural or spinal anesthesia
- age ≥ 30 years
- able to walk and communicate
Key exclusion criteria (2 listed)
- having any alteration of their state of consciousness
- altered mental status and communication
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 |
|---|---|---|
| Walk prescriptionAlso: prehabilitation30-40 minutes daily, for five days at the week, all weeks up to surgery. | Behavioural | Walk prescription |
| Conventional carePatient do not walk before surgery | Other | Conventional care |
Primary outcome
Length of stay
Time frame: Up 40 weeks in hospitalization
Total stay hours
3 secondary outcomes
Falls
Time frame: Up 40 weeks in hospitalization
Ischemic events
Time frame: Up 40 weeks in hospitalization
Time to the first walk
Time frame: Up 40 weeks in hospitalization
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 20 Mar 2018.
- Background: PubMed 20602503Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
- Background: PubMed 26300015Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966-9. doi: 10.1139/apnm-2015-0084. Epub 2015 May 13.
- Background: PubMed 21878237Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
- Derived from this study: PubMed 34321092Cortes OL, Herrera-Galindo M, Becerra C, Rincon-Roncancio M, Povea-Combariza C, Esparza-Bohorquez M. Preoperative walking recommendation for non-cardiac surgery patients to reduce the length of hospital stay: a randomized control trial. BMC Sports Sci Med Rehabil. 2021 Jul 28;13(1):80. doi: 10.1186/s13102-021-00317-w.
- Individual participant dataSharing planned: No. Data will be registered in indepenedent filles in folders; and also data will be typed on the PAMP Data base (CARDIECOL). Data can be monitored by a coordinator.
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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.
Olga Cortés, PI principal investigator
Fundación Cardioinfantil Instituto de Cardiología
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk prescription and Conventional care in people with Non-cardiac Surgery, run by Fundación Cardioinfantil Instituto de Cardiología at 2 sites in Colombia.
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 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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?
Length of stay (time frame: Up 40 weeks in hospitalization). 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 NCT03213496, which also lists 4 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 20 Mar 2018.