Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Sepsis or Septic Shock
- Sponsor
- Yonsei University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Severe functional disability
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •confirmed or suspected infection;
- •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%;
- •within 48 hours after arriving ER
Exclusion Criteria
- •severe functional disability before admission;
- •central nervous system infection;
- •contraindication for exercise rehabilitation according to the investigators' decision;
- •severe medical illness or mental problem or laboratory abnormality which can confound the results;
Outcomes
Primary Outcomes
Severe functional disability
Time Frame: 6 months after enrollment
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.