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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
26
The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity.
The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.
University of Miami
Miami, Florida, United States
Enrollment rate
Number of subjects enrolled into the study divided by number of subjects approached X 100%
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: Baseline, Day 5
Changes grip strength
Grip strength will be assessed using handgrip dynamometer.
Time frame: Baseline, Day 5
Changes grip strength at hospital discharge
Grip strength will be assessed using handgrip dynamometer.
Time frame: Day 5, Day 11
Changes in Foot Strength
Foot strength will be assessed objectively using hand-held dynamometer.
Time frame: Baseline, Day 5
Changes in Foot Strength at hospital discharge
Foot strength will be assessed objectively using hand-held dynamometer.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 5, Day 11