Exercise With Music for ICU Survivors

Critical Illness Clinical Trial

Official title:

Exercise With Music Program for ICU Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885687
• Other study ID #: 20180508
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: June 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit Syndrome

Intervention

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.
• Exercise
The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	Number of subjects enrolled into the study divided by number of subjects approached X 100%	One year
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Changes grip strength	Grip strength will be assessed using handgrip dynamometer.	Baseline, Day 5
Secondary	Changes grip strength at hospital discharge	Grip strength will be assessed using handgrip dynamometer.	Day 5, Day 11
Secondary	Changes in Foot Strength	Foot strength will be assessed objectively using hand-held dynamometer.	Baseline, Day 5
Secondary	Changes in Foot Strength at hospital discharge	Foot strength will be assessed objectively using hand-held dynamometer.	Day 5, Day 11
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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