Move to Music Video Intervention for ICU Survivors

Critical Illness Clinical Trial

— M2M-V  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04977297
• Other study ID #: 20201074
• Status: Completed
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Society of Critical Care Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in handgrip strength	Handgrip strength will be assessed using handgrip dynamometer.	baseline, up to 30 days
Secondary	Number of interventions completed	Number of interventions completed will be assessed from self-reported exercise diary.	day 5
Secondary	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
Secondary	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