Dose of Early Therapeutic Mobility: Does Type or Frequency Matter?

NCT00999011 | Completed DMC

• 2 other identifiers: NR10781-01A11R21NR010781-01A1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects of once and twice daily activity performed with patients who are breathing with the aid of a machine in an intensive care unit. Activity can occur in bed. Activity can include transfer to a chair and even walking once the patient's condition allows safe, out-of-bed activity. The investigators hypothesize that early, progressive activity will reduce inflammatory molecules in the blood, promote muscle and physical health and help patients to recover more quickly from critical illness.

Conditions

Critical Illness

Keywords

critical care; inflammatory biomarkers; cytokines; mechanical ventilation; activity; mobility therapy; More than 48 hours of mechanical ventilation

Outcome Measures

Primary Outcomes (17)

• Change in molecular biomarkers of inflammation day 1 of intervention

  IL-6, IL-10, C-reactive protein.

  1 day

• Change in molecular biomarkers of inflammation day 2 of intervention if patient still in ICU

  IL-6, IL-10, C-reactive protein.

  1 day

• Change in molecular biomarkers of inflammation day 3 of intervention if patient still in ICU

  IL-6, IL-10, C-reactive protein.

  1 day

• Vital Signs included RR, HR, and SBP. Change in Respiratory Rate day 1 of intervention.

  Change is Respiratory rate (RR),measured in breaths per minute, during the intervention and comparing to baseline (rest) only.

  Baseline = time during rest immediately preceding the intervention. Intervention = 30 min of activity

• Change in Respiratory Rate day 2 of intervention if patient still in ICU. Heart Rate and Systolic Blood Pressure. Each vital sign is measured separately and not aggregated.

  Breaths per minute as recorded on the bedside monitor Change defined as the difference between RR at rest and highest RR during the intervention.

  Baseline RR = time during rest immediately preceding the intervention. Intervention RR = 30 min activity

• Change in Respiratory Rate day3 of intervention if patient still in ICU.

  Breaths per minute as recorded on the bedside monitor Change defined as the difference between RR at rest and RR duriing activity.

  Baseline RR = time during rest immediately preceding the intervention. Intervention RR= during 30 min of activity

• Vital Signs. Change in Heart Rate day 1 of intervention

  Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.

  ring rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.

• Change in Heart Rate day 2 of intervention if patient still in ICU

  Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.

  Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.

• Change in Heart Rate day 3 if patient still in ICU

  Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.

  Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.

• Vital Signs , Change in Systolic Blood Pressure day 1

  Change in SBP, measured inmmHg, during the intervention only comparing to baseline. The bedside ICU monitor was used. The highest and lowest values were recorded for analysis. The largest change from baseline rest were used in analysis (Rest - Highest value obtained during intervention. This was done 3 times (once daily for up to 3 days) if randomized to once daily interventions or up to 6 times if randomized to twice daily intervention over 3 days.

  Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.

• Vital Signs. Change in Systolic Blood Pressure day 2 of intervention if patient still in ICU

  Change in Systolic blood pressure (SBP), measured in millimeters of mercury (mmHg) during the intervention comparing to baseline. The bedisde ICU monitor was used if an arterial indwelling line was present. An automatic BP cuff (dynometer) was used at the start and every 5 minutes if an indwelling line was used. The highest and lowest values were recorded during the intervention.

  Once daily or twice daily for up to 3 days on intervention. Baseline = time during rest immediately preceding the intervention Outcome = highest and lowest values during the mobility intervention.

• Change in Systolic Blood Pressure Day 3 of intervention if patient still in ICU

  Change in Systolic blood pressure (SBP), measured in millimeters of mercury (mmHg) during the intervention comparing to baseline. The bedisde ICU monitor was used if an arterial indwelling line was present. An automatic BP cuff (dynometer) was used at the start and every 5 minutes if an indwelling line was used. The highest and lowest values were recorded during the intervention.

  Once daily or twice daily for up to 3 days on intervention. Baseline = time during rest immediately preceding the intervention Outcome = highest and lowest values during the mobility intervention.

• The total number of days of Mechanical Ventilation while in the ICU

  . This is a one-time value. This is the total number of days the patient received invasive mechanical ventilation as documented in the record.

  Measured one time, at the discharge from the ICU

• Muscle strength day 1

  This was measured with hand grip using a dynometer and reported as dynes or kg of force.

  Measured once after the intervention on day 1. Collected as many as 3 times if the patient received 3 days of intervention

• Muscle strength day 2

  This was measured with hand grip using a dynometer and reported as dynes or kg of force.

  Measured once after the intervention. Collected as many as 3 times if the patient received 3 days of intervention

• Muscle strength day 3

  This was measured with hand grip using a dynometer and reported as dynes or kg of force.

  Measured once after the intervention. Collected as many as 3 times if the patient received 3 days of intervention

• Change in muscle strength

  This was defined as the difference in dynes from Day 1 to Day 3, if the patient was in the ICU for 3 days, or the change from Day 1 to 2 if in the ICU for only 2 days

  Collected once after the interention on days 1, 2, 3. The maximum potential change was defined as Day 1-Day 3 but Day 1 -Day was used for patients who were discharged from the ICU on Day 2 and had no data for Day 3

Study Arms (2)

One 20 minute period of activity daily

ACTIVE COMPARATOR

passive and/or active range of motion, chair sitting, sitting at edge of bed, standing and walking

Procedure: once daily mobility activity

Two periods of 20 minute activity daily

ACTIVE COMPARATOR

passive and/or active range of motion, chair sitting, sitting at edge of bed, standing and walking

Procedure: twice daily mobility activity

Interventions

once daily mobility activity PROCEDURE

in bed and out-of-bed activity including range of motion, chair sitting, sitting at edge of bed without weightbearing, standing, walking.

One 20 minute period of activity daily

twice daily mobility activity PROCEDURE

as with once daily. Goal is to progress intensity and duration of activity over time as patient condition improves for both arms

Two periods of 20 minute activity daily

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who require invasive mechanical ventilation for more than 24 continuous hours in the surgical (SICU) or medical ICU (MICU)
• a P:F ratio \> 100
• FiO2 \< 60% and PEEP less than 10 cmH20 at baseline

You may not qualify if:

• Patients for high risk of death will also be excluded, using criteria established by Norton et al.: ICU admission following a hospital stay of \>9 days in the past 12 months; age \>80 in the presence of 2 or more life-threatening illnesses (e.g., end-stage renal disease, severe heart failure (HF); diagnosis of an active stage IV malignancy; status post cardiac arrest; and diagnosis of intracerebral hemorrhage requiring mechanical ventilation.\[99\].
• Subjects over 400 pounds can be excluded from mobilization based on the judgment of the bedside nurse or project manager; if the risk for staff or patient harm from moving a patient with excessive weight is considered likely, mobilization will not occur.

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Nursing Research (NINR): collaborator
• MetroHealth Medical Center: collaborator

Study Sites (1)

Frances Payne Bolton School of Nursing Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Winkelman C, Sattar A, Momotaz H, Johnson KD, Morris P, Rowbottom JR, Thornton JD, Feeney S, Levine A. Dose of Early Therapeutic Mobility: Does Frequency or Intensity Matter? Biol Res Nurs. 2018 Oct;20(5):522-530. doi: 10.1177/1099800418780492. Epub 2018 Jun 14.

  PMID: 29902939 DERIVED

MeSH Terms

Conditions

Critical Illness; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Chris Winkelman, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 21, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: March 1, 2013
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)