Clinical trial NCT03885687: Exercise With Music for ICU Survivors
Official title: Exercise With Music Program for ICU Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Intensive Care Unit Syndrome
Keywords: Rehabilitation
Exercise
Music Intervention
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Enrollment rate
timeFrame: One year
measure: Acceptability of intervention as measured by a questionnaire
timeFrame: Day five
measure: Number of participants that complete the intervention as prescribed
timeFrame: Day 5
measure: Number of participants that complete the intervention beyond the 5-day mandatory sessions
timeFrame: Day 11
measure: Number of participants with adverse events
timeFrame: Day 5
Secondary outcomes:
measure: Effect size of the Exercise with Music intervention
timeFrame: One year
measure: Changes in activity
timeFrame: Baseline, Day 5
measure: Changes grip strength
timeFrame: Baseline, Day 5
measure: Changes grip strength at hospital discharge
timeFrame: Day 5, Day 11
measure: Changes in Foot Strength
timeFrame: Baseline, Day 5
measure: Changes in Foot Strength at hospital discharge
timeFrame: Day 5, Day 11
measure: Changes in Motivation (Visual Analog Scale)
timeFrame: Baseline, Day 5
measure: Changes in Motivation (Visual Analog Scale) at hospital discharge
timeFrame: Day 5, Day 11
measure: Changes in Anxiety (Visual Analog Scale)
timeFrame: Baseline, Day 5
measure: Changes in Anxiety (Visual Analog Scale) at hospital discharge
timeFrame: Day 5, Day 11
measure: Changes in Anxiety (NIH Toolbox)
timeFrame: Baseline, day 5
measure: Changes in Anxiety (NIH Toolbox) at hospital discharge
timeFrame: Day 5, Day 11
measure: Changes in Depression (NIH Toolbox)
timeFrame: Baseline, Day 5
measure: Changes in Depression (NIH Toolbox) at hospital discharge
timeFrame: Day 5, Day 11
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Zhan Liang
role: PRINCIPAL_INVESTIGATOR
References:
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.