Move to Music Video Intervention for ICU Survivors (M2M-V)

Move to Music Video Intervention - A Music and Video Guided Exercise Intervention for ICU Survivors

The purpose of this study is to determine if exercising with a music video program will improve physical functions of patients who have been discharged from an Intensive Care Unit (ICU).

Study Overview

• Status: Completed
• Conditions: Critical Illness; Intensive Care Unit Syndrome
• Intervention / Treatment: Behavioral: Move to Music -Video (M2M-V) Intervention; Behavioral: Move to Music Intervention (M2M)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhan Liang; Phone Number: 3052845468; Email: zxl667@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age ≥ 18 years old;
2. length of ICU stay >5 days (excludes patients with less comorbidity);
3. recruitment within 48 hours of ICU discharge (standardizes time to begin intervention);
4. able to independently move upper and lower extremities (required to participate in intervention);
5. cognitively able to complete the assessments and comply with physical testing instructions;
6. able to speak English or Spanish; and
7. reside at home prior to ICU admission.

Exclusion Criteria:

1. documented mental incompetence;
2. dependent status pre-ICU admission (assessed by the Katz Index of Independence in Activities of Daily Living);
3. evidence of delirium assessed using the Confusion Assessment Method;
4. hearing impairment;
5. documented "comfort measures only" or impending death;
6. prior residence in a long-term care facility; and
7. unstable clinical measures defined as Heart Rate (>140 beats/minute) or Respiratory Rate (>35 breaths/minute), blood pressure (systolic blood pressure >180 mmHg or < 90mmHg), ventilation problems, agitation, or perspiration. We will not enroll adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Move to Music Video Intervention; Participants in this arm will receive the Move to Music with Video (M2M-V) intervention. The participant will be asked to exercise twice daily for 5 consecutive days.	Behavioral: Move to Music -Video (M2M-V) Intervention; The move to music video (M2M-V) intervention pairs exercise with both music and video, thus providing both audio and visual stimulation. The intervention will be provided via an audio and video playlist that can be played on a phone, tablet, or computer. Each session lasts 10-15 minutes.
Active Comparator: Move to Music Intervention; Participants in this arm will receive the Move to Music (M2M) only intervention without video. The participant will be asked to exercise twice daily for 5 consecutive days.	Behavioral: Move to Music Intervention (M2M); The move to music (M2M) intervention pairs exercise with only music (no video), providing only audio stimulation. The intervention will be provided via an audio playlist that can be played on a phone, tablet, or computer. Each session lasts 10-15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in global health	Patient-Report Outcomes Measurement Information System (PROMIS) Global Health is a 10 item questionnaire representing physical health, pain, fatigue, mental health, social health and overall health. The questionnaire has a total score ranging from 10 to 50 with the higher score reflects better functioning.	baseline, up to 30 days
Change in physical activity	Physical 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.	baseline, day5
Change in handgrip strength	Handgrip strength will be assessed using handgrip dynamometer.	baseline, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of interventions completed	Number of interventions completed will be assessed from self-reported exercise diary.	day 5
Patient Satisfaction Survey Scores	Participants will complete a Patient Satisfaction survey by rating their experience of using the intervention from 1 to 5 with the higher score indicating a better experience.	day 5
Exercise motivation as measured by the Physical Activity Enjoyment Scale	The Physical Activity Enjoyment Scale assesses participant's motivation to exercise. The questionnaire has 16 items evaluated on a 7-point Likert Scale. The total score ranges from 16 to 112 with the lower score indicating greater enjoyment.	day 5

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Society of Critical Care Medicine
• Investigators: Principal Investigator: Zhan Liang, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 20201074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No