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

Severe Sepsis or Septic Shock Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845766
• Other study ID #: 4-2012-0710
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: April 11, 2016
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis or Septic Shock
• Shock, Septic

Intervention

Other:
• exercise rehabilitation

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after enrollment	No