Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis

Yonsei University40 enrolled

Overview

We hypothesized that early exercise rehabilitation for patients with severe sepsis or septic shock would decrease their functional disability and cognitive impairment. We plan to enroll patients with severe sepsis and septic shock who admitted an urban teaching hospital in Seoul, South Korea via ER. We will randomize those subjects into the intervention group which will take a standardized rehabilitation with routine clinical care for sepsis and the control group which will take routine clinical care for sepsis. And, we plan to assess their functional activity using ADL, IADL and SF-36, and cognitive function using MMSE at the time of enrollment, 28 days, and 6 months later.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Severe Sepsis or Septic Shock

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age ≥20; 2. confirmed or suspected infection; 3. two or more among 1)-4) 1) body temperature \>38˚C or \<36˚C 2) heart rate \>90/min 3) respiratory rate \>20/min or PaCO2\<32 mmHg 4) WBC \>12000/mm3, \<4000/mm3, or band forms \>10%; 4. within 48 hours after arriving ER Exclusion Criteria: 1. severe functional disability before admission; 2. central nervous system infection; 3. contraindication for exercise rehabilitation according to the investigators' decision; 4. severe medical illness or mental problem or laboratory abnormality which can confound the results; 5. pregnancy

Outcomes

Primary Outcomes

Severe functional disability

We will assess the functional activity with 0-11 score of 6 ADL(walking, dressing, bathing, eating, getting into and out of bed, toileting) and 5 IADL(preparing a hot meal, shopping for groceries, making telephone calls, taking medicines, managing money). If the patient has a score 4 or more, the patient will be considered to have a severe functional disability.

Time frame: 6 months after enrollment