Exercise With Music for ICU Survivors

NCT03885687 | Completed

• 1 other identifier: 20180508
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Intensive Care Unit Syndrome

Keywords

Rehabilitation; Exercise; Music Intervention

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (14)

• Effect size of the Exercise with Music intervention

  One year

• Changes in activity

  Baseline, Day 5

• Changes grip strength

  Baseline, Day 5

• Changes grip strength at hospital discharge

  Day 5, Day 11

• Changes in Foot Strength

  Baseline, Day 5

Study Arms (2)

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.

Behavioral: Exercise with Music

Active Control Group

ACTIVE COMPARATOR

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

Behavioral: Exercise

Interventions

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 with Music Intervention

Exercise BEHAVIORAL

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

Active Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

Related Publications (2)

• 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.

  PMID: 36638206 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.

  PMID: 34738474 DERIVED

MeSH Terms

Conditions

Critical Illness; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zhan Liang

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: March 22, 2019
• Study Start: March 5, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)