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

Not Applicable

Completed

• Conditions: Severe Sepsis or Septic Shock
• Interventions: Other: exercise rehabilitation

• Registration Number: NCT01845766
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rehabilitation arm	exercise rehabilitation	daily standardized exercise rehabilitation during the admission period, and daily standardized self exercise after discharge

Primary Outcome Measures

Name	Time	Method
Severe functional disability	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.

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of