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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise with Music Intervention | Experimental | The Exercise with Music intervention is a recorded exercise playlist, which is tailored to a patient's individual physical abilities and music choices. |
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| Active Control Group | Active Comparator | The active control group will receive exercise brochure and will be advised to exercise at least twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise with Music | Behavioral | The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhan Liang | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36638206 | Derived | Liang Z, Munro C, Yip H, Ji M, Sena Moore K, Ferreira T, Signorile JF, Pan Y. Randomized Controlled Study of Self-Managed Music-Guided Exercise Intervention Following Intensive Care. Nurs Res. 2023 May-Jun 01;72(3):193-199. doi: 10.1097/NNR.0000000000000644. Epub 2023 Jan 9. | |
| 34738474 | Derived | Liang Z, Yip H, Sena Moore K, Ferreira T, Ji M, Signorile JF, Munro C. Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors-A Pilot Randomized Controlled Study. Biol Res Nurs. 2022 Apr;24(2):145-151. doi: 10.1177/10998004211050297. Epub 2021 Nov 5. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise | Behavioral | The exercise group will receive exercise brochure and will be advised to exercise at least twice daily. |
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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 |