Back to resultsExercise With Music for ICU Survivors
Primary Purpose
Critical Illness, Intensive Care Unit Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise with Music
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness focused on measuring Rehabilitation, Exercise, Music Intervention
Eligibility Criteria
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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise with Music Intervention
Active Control Group
Arm Description
The Exercise with Music intervention is a recorded exercise playlist, which is tailored to a patient's individual physical abilities and music choices.
The active control group will receive exercise brochure and will be advised to exercise at least twice daily.
Outcomes
Primary Outcome Measures
Enrollment rate
Number of subjects enrolled into the study divided by number of subjects approached X 100%
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Changes grip strength
Grip strength will be assessed using handgrip dynamometer.
Changes grip strength at hospital discharge
Grip strength will be assessed using handgrip dynamometer.
Changes in Foot Strength
Foot strength will be assessed objectively using hand-held dynamometer.
Changes in Foot Strength at hospital discharge
Foot strength will be assessed objectively using hand-held dynamometer.
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".
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".
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".
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".
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03885687
Brief Title
Exercise With Music for ICU Survivors
Official Title
Exercise With Music Program for ICU Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Intensive Care Unit Syndrome
Keywords
Rehabilitation, Exercise, Music Intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise with Music Intervention
Arm Type
Experimental
Arm Description
The Exercise with Music intervention is a recorded exercise playlist, which is tailored to a patient's individual physical abilities and music choices.
Arm Title
Active Control Group
Arm Type
Active Comparator
Arm Description
The active control group will receive exercise brochure and will be advised to exercise at least twice daily.
Intervention Type
Behavioral
Intervention Name(s)
Exercise with Music
Intervention Description
The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.
Primary Outcome Measure Information:
Title
Enrollment rate
Description
Number of subjects enrolled into the study divided by number of subjects approached X 100%
Time Frame
One year
Title
Acceptability of intervention as measured by a questionnaire
Description
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
Title
Number of participants that complete the intervention as prescribed
Description
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
Title
Number of participants that complete the intervention beyond the 5-day mandatory sessions
Description
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
Title
Number of participants with adverse events
Description
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
Secondary Outcome Measure Information:
Title
Effect size of the Exercise with Music intervention
Description
Estimated effect size of the intervention on outcome measures to calculate sample size for a larger future study.
Time Frame
One year
Title
Changes in activity
Description
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
Title
Changes grip strength
Description
Grip strength will be assessed using handgrip dynamometer.
Time Frame
Baseline, Day 5
Title
Changes grip strength at hospital discharge
Description
Grip strength will be assessed using handgrip dynamometer.
Time Frame
Day 5, Day 11
Title
Changes in Foot Strength
Description
Foot strength will be assessed objectively using hand-held dynamometer.
Time Frame
Baseline, Day 5
Title
Changes in Foot Strength at hospital discharge
Description
Foot strength will be assessed objectively using hand-held dynamometer.
Time Frame
Day 5, Day 11
Title
Changes in Motivation (Visual Analog Scale)
Description
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
Title
Changes in Motivation (Visual Analog Scale) at hospital discharge
Description
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
Title
Changes in Anxiety (Visual Analog Scale)
Description
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
Title
Changes in Anxiety (Visual Analog Scale) at hospital discharge
Description
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
Title
Changes in Anxiety (NIH Toolbox)
Description
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
Title
Changes in Anxiety (NIH Toolbox) at hospital discharge
Description
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
Title
Changes in Depression (NIH Toolbox)
Description
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
Title
Changes in Depression (NIH Toolbox) at hospital discharge
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhan Liang
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34738474
Citation
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.
Results Reference
derived
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Exercise With Music for ICU Survivors
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