Recruiting

Mobility Dose

Sponsor:

Massachusetts General Hospital

Code:

NCT03196960

Conditions

Sarcopenia

Muscle Weakness

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).

Conditions

Sarcopenia

Muscle Weakness

Critical Illness

Study ID

NCT03196960

Start date

May 22, 2017

Status verified date

Sep, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (18 years of age or greater)
  • Barthel score ≥70 from a proxy describing patient function 2 weeks before admission
  • Expected stay on the ICU of >=3 days

Exclusion Criteria:

  • Patients transferred from other hospitals, long-term rehabilitation facilities or nursing homes with a preceding stay of more than 48 hours
  • Hospitalization 1 month prior to ICU admission >7 days
  • Discussion about changing the goals of care from cure to comfort
  • High risk of persistent brain injury (GCS<5 motor component and presence of TBI)
  • Patients with neurodegenerative diseases
  • Subjects with absence of a lower extremity
  • Patients with paraplegia or tetraplegia
  • Pregnancy

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Adverse Hospital Discharge Disposition [ Time Frame: Patient will be followed until hospital discharge, an expected 3 to 30 days ]

Central Contacts and Locations

Central contacts

Matthias Eikermann, MD PhD

(617) 726-3030meikermann@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 6, 2018

Last verified

Sep, 2018

Keywords

  • Mobilization Therapy
  • Critical Illness
  • Muscle Strength
  • Functional Mobility
  • Outcome
  • Intensive Care Unit
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2018-09-06.