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Completed

NCT Number: NCT03885687

Exercise With Music for ICU Survivors

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Exercise

Behavioral

The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.

Primary outcomes

  1. Enrollment rate

    Time frame: One year

    Number of subjects enrolled into the study divided by number of subjects approached X 100%

  2. Acceptability of intervention as measured by a questionnaire

    Time frame: 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.

  3. Number of participants that complete the intervention as prescribed

    Time frame: 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.

  4. Number of participants that complete the intervention beyond the 5-day mandatory sessions

    Time frame: 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.

  5. Number of participants with adverse events

    Time frame: 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 outcomes

  1. Effect size of the Exercise with Music intervention

    Time frame: One year

    Estimated effect size of the intervention on outcome measures to calculate sample size for a larger future study.

  2. Changes in activity

    Time frame: 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.

  3. Changes grip strength

    Time frame: Baseline, Day 5

    Grip strength will be assessed using handgrip dynamometer.

  4. Changes grip strength at hospital discharge

    Time frame: Day 5, Day 11

    Grip strength will be assessed using handgrip dynamometer.

  5. Changes in Foot Strength

    Time frame: Baseline, Day 5

    Foot strength will be assessed objectively using hand-held dynamometer.

  6. Changes in Foot Strength at hospital discharge

    Time frame: Day 5, Day 11

    Foot strength will be assessed objectively using hand-held dynamometer.

  7. Changes in Motivation (Visual Analog Scale)

    Time frame: 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".

  8. Changes in Motivation (Visual Analog Scale) at hospital discharge

    Time frame: 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".

  9. Changes in Anxiety (Visual Analog Scale)

    Time frame: 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".

  10. Changes in Anxiety (Visual Analog Scale) at hospital discharge

    Time frame: 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".

  11. Changes in Anxiety (NIH Toolbox)

    Time frame: 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.

  12. Changes in Anxiety (NIH Toolbox) at hospital discharge

    Time frame: 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.

  13. Changes in Depression (NIH Toolbox)

    Time frame: 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.

  14. Changes in Depression (NIH Toolbox) at hospital discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Exercise With Music Program for ICU Survivors

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2019
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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