Critical Illness Clinical Trial
Official title:
Exercise With Music Program for ICU Survivors
NCT number | NCT03885687 |
Other study ID # | 20180508 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 5, 2019 |
Est. completion date | August 1, 2019 |
Verified date | June 2020 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
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 |
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