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

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

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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