Protein Intake Associated With Physical Activity Related to Specific Outcomes (STRENGTH)

U

University of Sao Paulo

Status

Unknown

Conditions

Critically Ill
Surgery
Cancer

Treatments

Dietary Supplement: Control
Dietary Supplement: Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03438201
77623917.0.0000.0065

Details and patient eligibility

About

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.

Full description

Surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. During the hospital stay some measurements will be done. Such as resting energy expenditure (REE) before and after surgery; physical function evaluation; strength and quality of life. The proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.

Enrollment

126 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

126 participants in 2 patient groups

High-protein diet
Active Comparator group
Description:
High Protein Diet (2,0 - 2,5g/Kg body weight/day) Physical Activity protocol
Treatment:
Dietary Supplement: Intervention
Normoproteic diet
Active Comparator group
Description:
Standard Protein Diet (1,0 - 1,2g/Kg body weight/day) Physical Activity protocol
Treatment:
Dietary Supplement: Control

Trial contacts and locations

1

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Central trial contact

Ilana Roitman, RD; Juliano P Almeida, Professor

Data sourced from clinicaltrials.gov

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