Exercise With Music for ICU Survivors

Not Applicable

Completed

• Conditions: Critical Illness; Intensive Care Unit Syndrome
• Interventions: Behavioral: Exercise with Music; Behavioral: Exercise

• Registration Number: NCT03885687
• Lead Sponsor: University of Miami

Brief Summary

This project will test whether the individualized music-enhanced exercise playlist (Exercise with Music intervention) can prevent further physical and psychological deterioration and motivate ICU survivors to more actively participate in their rehabilitation.

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 First Submitted: 2018-12-06
• Study Start: 2019-03-05
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-22
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• age ≥ 18 years old
• length of ICU stay >5 days (excludes patients with less comorbidity)
• within 72 hours of ICU discharge (standardizes time to begin intervention)
• ability to independently move upper and lower extremities (required to participate in intervention)
• ability to speak English or Spanish

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Exclusion Criteria

• documented mental incompetence
• dependent status pre-ICU admission (KATZ, activity daily living scale)
• evidence of delirium using the Confusion Assessment Method (CAM)
• hearing impairment
• documented "comfort measures only" in the electronic medical record
• prior residence in a long-term care facility
• unstable hemodynamics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise with Music Intervention	Exercise with Music	The Exercise with Music intervention is a recorded exercise playlist, which is tailored to a patient's individual physical abilities and music choices.
Active Control Group	Exercise	The active control group will receive exercise brochure and will be advised to exercise at least twice daily.

Primary Outcome Measures

Name	Time	Method
Enrollment rate	One year	Number of subjects enrolled into the study divided by number of subjects approached X 100%
Acceptability of intervention as measured by a questionnaire	Day five	A self-designed 8-item questionnaire is administered to assess subjects' feedback regarding the intervention. Five questions are likert-scale questions (strongly disagree, disagree, undecided, agree, strongly agree); three questions are yes or no questions. If the results of the questionnaire show that majority of patients answer "agree or strongly agree" and "yes", this would indicate that the intervention is acceptable. If the results of the questionnaire show that majority of the patients answer "strongly disagree or disagree" and "no", this would indicate that the intervention is not acceptable.
Number of participants that complete the intervention beyond the 5-day mandatory sessions	Day 11	Count of participants who complete additional exercise sessions beyond the prescribed exercise regimen (twice daily for five days). Each session includes five movements.
Number of participants that complete the intervention as prescribed	Day 5	Count of participants who exercise twice daily for five days (upper and lower extremity exercise). Each session includes five movements. The number of movements and sessions of the intervention delivered within and beyond the 5-day mandatory regimen will be documented.
Number of participants with adverse events	Day 5	Adverse events are any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.

Secondary Outcome Measures

Name	Time	Method
Effect size of the Exercise with Music intervention	One year	Estimated effect size of the intervention on outcome measures to calculate sample size for a larger future study.
Changes grip strength at hospital discharge	Day 5, Day 11	Grip strength will be assessed using handgrip dynamometer.
Changes in Foot Strength	Baseline, Day 5	Foot strength will be assessed objectively using hand-held dynamometer.
Changes in Anxiety (NIH Toolbox)	Baseline, day 5	Anxiety will also be assessed using the NIH Toolbox Emotion Battery (fear-affect survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always." The survey is scored using IRT methods. Higher scores are indicative of more feelings of anxiety.
Changes in Depression (NIH Toolbox) at hospital discharge	Day 5, Day 11	Depression will be assessed using the NIH Toolbox Emotion Battery (sadness survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always" (adults) or "almost always". higher scores are indicative of more depressive.
Changes in Anxiety (Visual Analog Scale)	Baseline, Day 5	Anxiety will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "no anxiety"; "100" indicates "extremely anxious".
Changes in Anxiety (Visual Analog Scale) at hospital discharge	Day 5, Day 11	Anxiety will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "no anxiety"; "100" indicates "extremely anxious".
Changes in Anxiety (NIH Toolbox) at hospital discharge	Day 5, Day 11	Anxiety will also be assessed using the NIH Toolbox Emotion Battery (fear-affect survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always." The survey is scored using IRT methods. Higher scores are indicative of more feelings of anxiety.
Changes in activity	Baseline, Day 5	Activity will be monitored using an Actiwatch (Philips Respironics) placed on subjects' wrists at enrollment. The Actiwatch is a small, lightweight, limb-worn activity monitoring device. It contains an accelerometer that is capable of sensing any motion with minimal acceleration of 0.01g to measure long-term gross motor activity and intensity of motion.
Changes grip strength	Baseline, Day 5	Grip strength will be assessed using handgrip dynamometer.
Changes in Depression (NIH Toolbox)	Baseline, Day 5	Depression will be assessed using the NIH Toolbox Emotion Battery (sadness survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always" (adults) or "almost always". higher scores are indicative of more depressive.
Changes in Foot Strength at hospital discharge	Day 5, Day 11	Foot strength will be assessed objectively using hand-held dynamometer.
Changes in Motivation (Visual Analog Scale)	Baseline, Day 5	Motivation will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "not motivated to do exercise at all"; "100" indicates "extremely motivated to do exercise".
Changes in Motivation (Visual Analog Scale) at hospital discharge	Day 5, Day 11	Motivation will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "not motivated to do exercise at all"; "100" indicates "extremely motivated to do exercise".

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States