An interventional study of High protein nutrition and Cycle ergometry exercise in Critically Ill Patients, sponsored by Hospital Sao Domingos. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by Hospital Sao Domingos · Not applicable, Interventional, and Treatment
Among 350 studies in Motor Activity with a site in Brazil — 41 open to participants now, 52 under way, none of them phase 3. Motor Activity · Brazil.
Among the 350 studies in Motor Activity with a site in Brazil, this one is the 28th largest by enrollment of the 328 interventional ones that give a count, is one of 30 that started in 2018, is one of 296 with no phase, and was the 199th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →41 of the 350 studies in Motor Activity with a site in Brazil are open now. Recruiting first, the newest first:
São Paulo State University · Sites in Brazil
Federal University of Jatai · Sites in Brazil
Universidade Estadual do Norte do Parana · Sites in Brazil
Universidade Federal do Paraná · Sites in Brazil
Hospital de Clinicas de Porto Alegre · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
350 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 5 · Phase 3 12 · Phase 4 9
First in 1999; this study’s year is marked. 30 started in 2018.
This study's enrollment of 180 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 44 across the 328 interventional studies, 97 across the 22 observational. Of the 214 that completed or were terminated, 12 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 350 have an industry lead sponsor. The 10 most frequent:
Hospital Sao Domingos is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Hospital Sao Domingos has 1 study filed under Motor Activity — fewer than ten, so there is no comparison to draw.
13 of the studies in Motor Activity with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07730255University of Sao PauloExercise and Taurine Supplementation on Intramuscular Fat in Older Women With Obesity | 2026-12 |
| NCT07561359Hospital de Clinicas de Porto Alegre12-Week Strength and Functional Exercise Program for Hereditary Spastic Paraplegia Trial (HSPMOVE) | 2026-12 |
| NCT07621523Universidade Estadual do Norte do ParanaEnergy Cost and Metabolic Intensity of Pilates Exercises in Older Adults | 2026-12 |
| NCT07155967Paulista UniversityEffect of Cross-Education in Blood Flow Restriction Resistance Training on Lower Limbs in Older Women | 2026-12-01 |
| NCT06636006Universidade Federal de GoiasAerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia | 2026-12-30 |
Among the 350 studies in Motor Activity with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study analyse the impact of high protein intake associated to early programed exercise on functional outcomes of adult intensive care patients.
The muscle weakness associated to intensive care, one of the components of Post Intensive Care Syndrome (PICS) has a significant impact on the short-term and long-term outcomes in the critically ill patient (1, 2). Puthucheary et al. (3) analyzed 63 septic patients with imaging examination and established a clear relationship between the number of organ failures and muscle loss in the first 10 days of ICU. Although a study involving 244 critically ill patients has shown an alarming relationship between reduced muscle mass at admission and mortality (4), evidences that nutritional interventions can attenuate muscle loss and result in improvement in outcome are unclear. Recent studies evaluating the impact of nutritional therapy on clinical outcomes have surprisingly demonstrated that patients who received full nutritional intake did not differ in outcomes when compared to those receiving reduced nutritional intake, the so-called permissive underfeeding (5, 6, 7). Careful analysis of these studies, however, reveals that the authors define hyponutrition as synonymous with reduced calorie intake, without mentioning the protein intake offered to the patients. The study with the greatest scientific repercussion (8) used reduced caloric intake in the study group, but the protein intake did not differ between groups. Observational studies comparing high protein intake with conventional intake have shown improvement in outcome indicators in patients receiving more than 1.6 and even more than 2.0 g / kg / day of protein (9, 10). Recently the intensive care medicine research agenda published in the journal of the European Society of Intensive Care Medicine, the top priority of the nutrition research in the critically ill patients was to compare normal and hyperproteic nutrition ideally associated with physical activity (11). Several recent studies have shown benefits of early physical rehabilitation in the critically ill patient (12, 13).
The optimal integration between adequate protein intake and exercise in the critically ill patient may have an impact on short- and long-term outcomes, but this hypothesis has not yet been tested by studies with a good methodology. The hypothesis of this prospective randomized phase II study is that the association of high protein intake with early physical rehabilitation improves physical function after hospital discharge with a significant impact on quality of life.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
We will include 180 consecutive patients admitted to one of the study ICUs
Exclusion Criteria:
Begining within 48 hours of ICU admission participants will receive nutrition support with energy expenditure measured by indirect calorimetry, 2.0 to 2.2 g/kg/day of protein and in-bed cycle ergometry exercise.
Dietary Supplement: High protein nutrition · Device: Cycle ergometry exercise
Participants randomized to the usual care group will receive usual care protein and exercise
Other: Usual care group
Patients in the HPE group will be submitted to nutritional support preferably through the enteral route. Energy expenditure will be determined by indirect calorimetry. They will receive 2.0 to 2.2 grams/kg/day of protein.
Patients will be submitted to two daily sessions of exercise (cycle ergometry) 15 minutes duration each, during the 7 days of the week. The intervention will be maintained exclusively duting the patient's stay in the ICU. The cycle ergometer will be the MotoMed Letto II (Reck Technik, Germany).
Participants randomized to the usual care group will receive usual care protein and exercise.
Also known as: No intervention
Physical component summary (PCS) 3 months after randomization
Blind assessment of PCS after 3 months after randomization
Time frame: 3 months after randomization
Physical component summary (PCS) 6 months after randomization
Blind assessment of PCS after 6 months after randomization
Time frame: 6 months after randomization
handgrip strength
handgrip strength measured at ICU discharge,
Time frame: 20 days
Duration of mechanical ventilation
Length of time under mechanical ventilation
Time frame: 20 days
Length of ICU stay
Length of ICU stay
Time frame: 20 days
Hospital mortality
Hospital mortality
Time frame: 6 months
Plan to share: No
Ran from Jun 2018 to primary completion in Dec 2019, 18 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 18 months is close to that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Sao Domingos