Older PeopleSPASNCT05057741
Surgical Prehabilitation in Abdominal Surgery
A study testing Multimodal prehabilitation in people with Older People and Prehabilitation, run by Universidad del Rosario at 1 site in Colombia.
Trial summary
Randomized clinical trial evaluating changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program, compared to non-prehabilitated patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older People, Prehabilitation, Surgical Procedure
- What is being tested?
- Multimodal prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteColombia
- Study dates
- 23 Feb 2022to 23 Jun 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled by the General Surgery, Coloproctology and Hepatobiliary Surgery services
- Cognitive ability to follow instructions,
- Understand the material delivered (basic reading comprehension - through physical or digital media)
- Perform physical exercise.
- Aptitude to exercise according to the cardiovascular risk assessment performed by the treating physician.
Who cannot join
- Patients scheduled for surgery from the emergency department
- Patients with sepsis,
- Patients with metastatic disease, without curative perspective
- Patients with dysphagia for solid foods
- Patients with incapacitating psychiatric or neurological illnesses
- Patients with documented previous immunosuppression status (corticosteroid users in the 6 weeks prior to the randomisation) and/or HIV
Show all 10Show fewer
- Diabetic patients, with chronic renal disease, stage 4-5, with renal replacement therapy
- Patients with heart failure decompensated, or that limits the physical exercise
- Patients with dependent mobility
- Patients with history of second primary neoplasm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Prehabilitation of Patients Taken to Major Gastrointestinal Surgery.
Randomized clinical trial evaluating changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program, compared to non-prehabilitated patients.
Read the detailed description
Introduction: A surgical procedure can have repercussions on the functionality and quality of life of patients, reducing their functional capacity by up to 40%; poor preoperative physical performance increases the risk of perioperative morbidity and mortality by 30% and prolongs functional recovery, increasing the hospital stay of the older adult. Prehabilitation is a preoperative intervention that improves the physical, psychological and nutritional condition of the patient to obtain a better postoperative recovery, mobility and functional independence.
Objective: To evaluate changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program (exercise, nutrition and relaxation).
Methodology: Randomized clinical trial. Two study groups will be compared, an experimental group that will receive the educational intervention (multimodal prehabilitation program) and a control group that will continue with the usual management in the Hospital. The project activities will be carried out in Telehealth modality due to COVID-19 contagion containment measures.
Expected results: To encourage interprofessional work based on common goals with standardization of data and processes to improve physical condition and reduce post-surgical complications; to establish traceability of care, clinical and functional condition of the patient. It is intended to generate scientific evidence, integrate the research groups Méderi, Rehabilitation Sciences and Clinical Research.
- Conditions
- Older People, Prehabilitation, Surgical Procedure
- Being tested
- Multimodal prehabilitation
- Keywords
- surgical procedure, exercise, nutritional, functional condition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitationBehavioural
Patients who will receive a multimodal prehabilitation program consisting of guided self-care activities at home that include exercise, nutrition and relaxation. Information Will be share by e health. Monitored by telephone daily during the first week and three times a week between the second and fourth week.
The final evaluation of the program will be performed one working day after the control appointment with surgery, which will be scheduled ten days after hospital discharge; and the satisfaction survey will be applied. At 30 days after surgery, a telephone follow-up will be made to inquire about complications and mortality. On that day, self-care recommendations will be given.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Prehabilitation | Experimental | Multimodal prehabilitation: exercise, nutrition and relaxation Receives: Behavioral: Multimodal prehabilitation |
| Standard of Care | No intervention | Usual care group: advice of surgeons about self care |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capacity
Changes in the maximum capacity to carry and use oxygen measured with the 2-minute stationary gait test (2MSG)
Measured: One to six weeks
Secondary outcomes (1)
postoperative complications
Presence of morbidities, whether or not requiring hospital readmission, generated by the surgical procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start23 Feb 2022
- Primary completion22 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies 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
- A randomized clinical trial will be performed. Two study groups will be compared, an experimental group that will receive the educational intervention (multimodal prehabilitation program) and a control group that will continue with the usual management in the Hospital. The project activities will be carried out in Telehealth modality. When the patient accepts to participate in the study and signs the informed consent, he/she will be evaluated by nutrition and physiotherapy. After the initial evaluation that confirms the selection criteria, the patient will be randomly assigned to the study groups, by means of a computer based randomisation program. The evaluators of the initial and final conditions of the patients will not know the group to which each patient entering the study has been assigned. The study will be conducted following good clinical practice. The estimated duration of recruitment is sixteen months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Rosario
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Mayor Mederi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057741
- Sponsor's protocol ID
- CEI DVO005 1567-CV1324
- Other IDs
- B- 17-2020
- Acronym
- SPAS
- Status last verified
- Jun 2024
- First submitted
- 15 Sep 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Prehabilitation of Patients Taken to Major Gastrointestinal Surgery.
- ClinicalTrials.gov ID
- NCT05057741
- Acronym / sponsor ID
- SPAS / CEI DVO005 1567-CV1324
- Conditions
- Older People, Prehabilitation, Surgical Procedure
- Keywords
- surgical procedure, exercise, nutritional, functional condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad del RosarioUniversity, hospital or other
- Collaborators
- Hospital Universitario Mayor Mederi
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 27 Sep 2021 (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.
Randomized clinical trial evaluating changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program, compared to non-prehabilitated patients.
Detailed description
Introduction: A surgical procedure can have repercussions on the functionality and quality of life of patients, reducing their functional capacity by up to 40%; poor preoperative physical performance increases the risk of perioperative morbidity and mortality by 30% and prolongs functional recovery, increasing the hospital stay of the older adult. Prehabilitation is a preoperative intervention that improves the physical, psychological and nutritional condition of the patient to obtain a better postoperative recovery, mobility and functional independence.
Objective: To evaluate changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program (exercise, nutrition and relaxation).
Methodology: Randomized clinical trial. Two study groups will be compared, an experimental group that will receive the educational intervention (multimodal prehabilitation program) and a control group that will continue with the usual management in the Hospital. The project activities will be carried out in Telehealth modality due to COVID-19 contagion containment measures.
Expected results: To encourage interprofessional work based on common goals with standardization of data and processes to improve physical condition and reduce post-surgical complications; to establish traceability of care, clinical and functional condition of the patient. It is intended to generate scientific evidence, integrate the research groups Méderi, Rehabilitation Sciences and Clinical Research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized clinical trial will be performed. Two study groups will be compared, an experimental group that will receive the educational intervention (multimodal prehabilitation program) and a control group that will continue with the usual management in the Hospital. The project activities will be carried out in Telehealth modality. When the patient accepts to participate in the study and signs the informed consent, he/she will be evaluated by nutrition and physiotherapy. After the initial evaluation that confirms the selection criteria, the patient will be randomly assigned to the study groups, by means of a computer based randomisation program. The evaluators of the initial and final conditions of the patients will not know the group to which each patient entering the study has been assigned. The study will be conducted following good clinical practice. The estimated duration of recruitment is sixteen months.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Prehabilitation | Experimental | Behavioral: Multimodal prehabilitationMultimodal prehabilitation: exercise, nutrition and relaxation |
| Standard of Care | No intervention | –Usual care group: advice of surgeons about self care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled by the General Surgery, Coloproctology and Hepatobiliary Surgery services
- Cognitive ability to follow instructions,
- Understand the material delivered (basic reading comprehension - through physical or digital media)
- Perform physical exercise.
- Aptitude to exercise according to the cardiovascular risk assessment performed by the treating physician.
Key exclusion criteria (10 listed)
- Patients scheduled for surgery from the emergency department
- Patients with sepsis,
- Patients with metastatic disease, without curative perspective
- Patients with dysphagia for solid foods
- Patients with incapacitating psychiatric or neurological illnesses
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 |
|---|---|---|
| Multimodal prehabilitationPatients who will receive a multimodal prehabilitation program consisting of guided self-care activities at home that include exercise, nutrition and relaxation. Information Will be share by e health. Monitored by telephone daily during the first week and three times a week between the second and fourth week. The final evaluation of the program will be performed one working day after the control appointment with surgery, which will be scheduled ten days after hospital discharge; and the satisfaction survey will be applied. At 30 days after surgery, a telephone follow-up will be made to inquire about complications and mortality. On that day, self-care recommendations will be given. | Behavioural | Multimodal Prehabilitation |
Primary outcome
functional capacity
Time frame: One to six weeks
Changes in the maximum capacity to carry and use oxygen measured with the 2-minute stationary gait test (2MSG)
1 secondary outcome
postoperative complications
Time frame: 30 days
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 14 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation in people with Older People and Prehabilitation, run by Universidad del Rosario at 1 site 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 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 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 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?
functional capacity (time frame: One to six weeks). 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 14 Jun 2024.