Exercise With Music for ICU Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Exercise With Music Program for ICU Survivors

Conditions
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Critical Illness, Intensive Care Unit Syndrome

Intervention / Treatment
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* Behavioral: Exercise with Music
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise with Music Intervention<br>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<br>* The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity.<br>|
| Active Comparator: Active Control Group<br>The active control group will receive exercise brochure and will be advised to exercise at least twice daily. | Behavioral: Exercise<br>* The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music Intervention, Rehabilitation, Exercise