Critical Illness, Intensive Care Unit Syndrome
Conditions
Keywords
Rehabilitation, Exercise, Music Intervention
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.
Interventions
BEHAVIORALExercise with Music
The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity.
BEHAVIORALExercise
The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | One year | Number of subjects enrolled into the study divided by number of subjects approached X 100% |
| Acceptability of intervention as measured by a questionnaire | 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. |
| Number of participants that complete the intervention as prescribed | 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. |
| Number of participants that complete the intervention beyond the 5-day mandatory sessions | 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. |
| Number of participants with adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Foot Strength | Baseline, Day 5 | Foot strength will be assessed objectively using hand-held dynamometer. |
| Changes in Foot Strength at hospital discharge | Day 5, Day 11 | Foot strength will be assessed objectively using hand-held dynamometer. |
| Changes in Motivation (Visual Analog Scale) | 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. |
| Changes in Motivation (Visual Analog Scale) at hospital discharge | 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. |
| Changes in Anxiety (NIH Toolbox) at hospital discharge | 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. |
| Changes in Anxiety (Visual Analog Scale) at hospital discharge | 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. |
| Changes in Anxiety (NIH Toolbox) | 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. |
| Changes in Depression (NIH Toolbox) | 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. |
| Changes in Depression (NIH Toolbox) at hospital discharge | 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. |
| Changes in Anxiety (Visual Analog Scale) | 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. |
| Effect size of the Exercise with Music intervention | One year | Estimated effect size of the intervention on outcome measures to calculate sample size for a larger future study. |
| Changes in activity | 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. |
| Changes grip strength | Baseline, Day 5 | Grip strength will be assessed using handgrip dynamometer. |
| Changes grip strength at hospital discharge | Day 5, Day 11 | Grip strength will be assessed using handgrip dynamometer. |
Countries
United States
Outcome results
None listed