Protein Intake Associated With Physical Activity Related to Specific Outcomes
STRENGTH
The Efficiency of Different Amount of Protein Intake Associated With a Physical Activity Protocol in Surgical Cancer Patients Admitted to the Intensive Care Unit : Randomized Controlled Trial
1 other identifier
interventional
126
1 country
1
Brief Summary
This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the ICU in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFebruary 19, 2018
February 1, 2018
6 months
January 29, 2018
February 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Function
6 minutes walk test
8 days after randomization
Secondary Outcomes (6)
Physical Function
30 days after randomization
Quality of life
6 months after randomization
Body Composition related to prognosis
8 days after randomization
Postoperative complications
30 days after randomization
Resting Energy Expenditure
one day before surgery and one day after surgery
- +1 more secondary outcomes
Study Arms (2)
High-protein diet
ACTIVE COMPARATORHigh Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol
Normoproteic diet
ACTIVE COMPARATORStandard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol
Interventions
Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day
Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day
Eligibility Criteria
You may qualify if:
- Cancer patients
- Age greater than or equal to 18 years old
- Have a tendency to be admitted to the ICU after the surgery
- Fill the eligible criteria to start enteral feeding within 72 hours
- Sign the consent form;
You may not qualify if:
- Mechanical ventilation such as fraction of inspired oxygen inspired oxygen fraction (FiO2) \>60% or positive end expiratory pressure (PEEP) \> 12cm H2O
- Bronchopleural fistula
- Karnofsky \<50
- Participant cannot b enrolled in another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine University of Sao Paulo
São Paulo, São Paulo, 01246-903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliano P Almeida, Professor
University of Sao Paulo
- PRINCIPAL INVESTIGATOR
Ilana Roitman
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 19, 2018
Study Start
April 4, 2018
Primary Completion
October 12, 2018
Study Completion
April 30, 2020
Last Updated
February 19, 2018
Record last verified: 2018-02