Exercise With Music for ICU Survivors

Exercise With Music Program for ICU Survivors

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Intensive Care Unit Syndrome
• Intervention / Treatment: Behavioral: Exercise with Music; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise with Music Intervention; The Exercise with Music intervention is a recorded exercise playlist, which is tailored to a patient's individual physical abilities and music choices.	Behavioral: Exercise with Music; The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity.
Active Comparator: Active Control Group; The active control group will receive exercise brochure and will be advised to exercise at least twice daily.	Behavioral: Exercise; The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Number of subjects enrolled into the study divided by number of subjects approached X 100%	One year
Acceptability of intervention as measured by a questionnaire	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.	Day five
Number of participants that complete the intervention as prescribed	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.	Day 5
Number of participants that complete the intervention beyond the 5-day mandatory sessions	Count of participants who complete additional exercise sessions beyond the prescribed exercise regimen (twice daily for five days). Each session includes five movements.	Day 11
Number of participants with adverse events	Adverse events are any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.	Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect size of the Exercise with Music intervention	Estimated effect size of the intervention on outcome measures to calculate sample size for a larger future study.	One year
Changes in activity	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.	Baseline, Day 5
Changes grip strength	Grip strength will be assessed using handgrip dynamometer.	Baseline, Day 5
Changes grip strength at hospital discharge	Grip strength will be assessed using handgrip dynamometer.	Day 5, Day 11
Changes in Foot Strength	Foot strength will be assessed objectively using hand-held dynamometer.	Baseline, Day 5
Changes in Foot Strength at hospital discharge	Foot strength will be assessed objectively using hand-held dynamometer.	Day 5, Day 11
Changes in Motivation (Visual Analog Scale)	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".	Baseline, Day 5
Changes in Motivation (Visual Analog Scale) at hospital discharge	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".	Day 5, Day 11
Changes in Anxiety (Visual Analog Scale)	Anxiety will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "no anxiety"; "100" indicates "extremely anxious".	Baseline, Day 5
Changes in Anxiety (Visual Analog Scale) at hospital discharge	Anxiety will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "no anxiety"; "100" indicates "extremely anxious".	Day 5, Day 11
Changes in Anxiety (NIH Toolbox)	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.	Baseline, day 5
Changes in Anxiety (NIH Toolbox) at hospital discharge	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.	Day 5, Day 11
Changes in Depression (NIH Toolbox)	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.	Baseline, Day 5
Changes in Depression (NIH Toolbox) at hospital discharge	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.	Day 5, Day 11

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Zhan Liang, University of Miami

Publications and helpful links

General Publications

• Liang Z, Yip H, Sena Moore K, Ferreira T, Ji M, Signorile JF, Munro C. Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors-A Pilot Randomized Controlled Study. Biol Res Nurs. 2022 Apr;24(2):145-151. doi: 10.1177/10998004211050297. Epub 2021 Nov 5.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Music Intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 20180508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No