Exercise With Music for ICU Survivors

• ClinicalTrials.gov Identifier: NCT03885687
• Recruitment Status: Completed
• First Posted: March 22, 2019
• Last Update Posted: June 29, 2020
• Sponsor: University of Miami
• Information provided by (Responsible Party): Zhan Liang, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Critical Illness; Intensive Care Unit Syndrome	Behavioral: Exercise with Music; Behavioral: Exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Exercise With Music Program for ICU Survivors
• Actual Study Start Date: March 5, 2019
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: August 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Enrollment rate [ Time Frame: One year ]
   Number of subjects enrolled into the study divided by number of subjects approached X 100%
2. Acceptability of intervention as measured by a questionnaire [ Time Frame: 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.
3. Number of participants that complete the intervention as prescribed [ Time Frame: 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.
4. Number of participants that complete the intervention beyond the 5-day mandatory sessions [ Time Frame: 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.
5. Number of participants with adverse events [ Time Frame: 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 :

1. Effect size of the Exercise with Music intervention [ Time Frame: One year ]
   Estimated effect size of the intervention on outcome measures to calculate sample size for a larger future study.
2. Changes in activity [ Time Frame: 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.
3. Changes grip strength [ Time Frame: Baseline, Day 5 ]
   Grip strength will be assessed using handgrip dynamometer.
4. Changes grip strength at hospital discharge [ Time Frame: Day 5, Day 11 ]
   Grip strength will be assessed using handgrip dynamometer.
5. Changes in Foot Strength [ Time Frame: Baseline, Day 5 ]
   Foot strength will be assessed objectively using hand-held dynamometer.
6. Changes in Foot Strength at hospital discharge [ Time Frame: Day 5, Day 11 ]
   Foot strength will be assessed objectively using hand-held dynamometer.
7. Changes in Motivation (Visual Analog Scale) [ Time Frame: 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".
8. Changes in Motivation (Visual Analog Scale) at hospital discharge [ Time Frame: 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".
9. Changes in Anxiety (Visual Analog Scale) [ Time Frame: 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".
10. Changes in Anxiety (Visual Analog Scale) at hospital discharge [ Time Frame: 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".
11. Changes in Anxiety (NIH Toolbox) [ Time Frame: 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.
12. Changes in Anxiety (NIH Toolbox) at hospital discharge [ Time Frame: 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.
13. Changes in Depression (NIH Toolbox) [ Time Frame: 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.
14. Changes in Depression (NIH Toolbox) at hospital discharge [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33146

Sponsors and Collaborators

University of Miami

Investigators

• Principal Investigator: Zhan Liang; University of Miami

More Information

• Responsible Party: Zhan Liang, Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03885687
• Other Study ID Numbers: 20180508
• First Posted: March 22, 2019
• Last Update Posted: June 29, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Zhan Liang, University of Miami:

Rehabilitation; Exercise; Music Intervention

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes