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

NCT ID: NCT01845766

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-11-30

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.

Conditions

Severe Sepsis or Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

rehabilitation arm

daily standardized exercise rehabilitation during the admission period, and daily standardized self exercise after discharge

Group Type: EXPERIMENTAL

exercise rehabilitation

Intervention Type: OTHER

control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exercise rehabilitation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei University College of Medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2012-0710

Identifier Type: -

Identifier Source: org_study_id