Back to resultsEffects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis
Primary Purpose
Severe Sepsis or Septic Shock
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
exercise rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Severe Sepsis or Septic Shock focused on measuring sepsis, septic shock, rehabilitation, exercise
Eligibility Criteria
Inclusion Criteria:
- age ≥20;
- 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;
- pregnancy
Sites / Locations
- Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
rehabilitation arm
control arm
Arm Description
daily standardized exercise rehabilitation during the admission period, and daily standardized self exercise after discharge
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01845766
Brief Title
Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis or Septic Shock
Keywords
sepsis, septic shock, rehabilitation, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rehabilitation arm
Arm Type
Experimental
Arm Description
daily standardized exercise rehabilitation during the admission period, and daily standardized self exercise after discharge
Arm Title
control arm
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
exercise rehabilitation
Primary Outcome Measure Information:
Title
Severe functional disability
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥20;
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;
pregnancy
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Early Exercise Rehabilitation on Long-term Functional Recovery in Patients With Severe Sepsis
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