Move to Music Video Intervention for ICU Survivors

Study Overview
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Brief Summary
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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).

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

Conditions
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Critical Illness, Intensive Care Unit Syndrome

Intervention / Treatment
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* Behavioral: Move to Music Intervention (M2M)
* Behavioral: Move to Music -Video (M2M-V) Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years old; length of ICU stay >5 days (excludes patients with less comorbidity); recruitment within 48 hours of ICU discharge (standardizes time to begin intervention); able to independently move upper and lower extremities (required to participate in intervention); cognitively able to complete the assessments and comply with physical testing instructions; able to speak English or Spanish; and reside at home prior to ICU admission. Exclusion Criteria: documented mental incompetence; dependent status pre-ICU admission (assessed by the Katz Index of Independence in Activities of Daily Living); evidence of delirium assessed using the Confusion Assessment Method; hearing impairment; documented comfort measures only or impending death; prior residence in a long-term care facility; and 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Move to Music Video Intervention<br>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<br>* 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.<br>|
| Active Comparator: Move to Music Intervention<br>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)<br>* 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.<br>|

What is the study measuring?
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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 |