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

NCT01845766 | Completed

• 1 other identifier: 4-2012-0710
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

sepsis, septic shock, rehabilitation, exercise

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

rehabilitation arm

EXPERIMENTAL

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

Other: exercise rehabilitation

control arm

NO INTERVENTION

Interventions

exercise rehabilitation OTHER

rehabilitation arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

KR (1)