Back to resultsMove to Music Video Intervention for ICU Survivors (M2M-V)
Primary Purpose
Critical Illness, Intensive Care Unit Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Move to Music Intervention (M2M)
Move to Music -Video (M2M-V) Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness
Eligibility Criteria
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.
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Move to Music Video Intervention
Move to Music Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Change in handgrip strength
Handgrip strength will be assessed using handgrip dynamometer.
Secondary Outcome Measures
Number of interventions completed
Number of interventions completed will be assessed from self-reported exercise diary.
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.
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.
Full Information
NCT ID
NCT04977297
First Posted
May 12, 2021
Last Updated
January 24, 2023
Sponsor
University of Miami
Collaborators
Society of Critical Care Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04977297
Brief Title
Move to Music Video Intervention for ICU Survivors
Acronym
M2M-V
Official Title
Move to Music Video Intervention - A Music and Video Guided Exercise Intervention for ICU Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Society of Critical Care Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Intensive Care Unit Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Move to Music Video Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Move to Music Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Move to Music Intervention (M2M)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Move to Music -Video (M2M-V) Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in global health
Description
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.
Time Frame
baseline, up to 30 days
Title
Change in physical activity
Description
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.
Time Frame
baseline, day5
Title
Change in handgrip strength
Description
Handgrip strength will be assessed using handgrip dynamometer.
Time Frame
baseline, up to 30 days
Secondary Outcome Measure Information:
Title
Number of interventions completed
Description
Number of interventions completed will be assessed from self-reported exercise diary.
Time Frame
day 5
Title
Patient Satisfaction Survey Scores
Description
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.
Time Frame
day 5
Title
Exercise motivation as measured by the Physical Activity Enjoyment Scale
Description
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.
Time Frame
day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhan Liang
Phone
3052845468
Email
zxl667@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhan Liang, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhan Liang
Phone
305-284-5468
Email
zxl667@miami.edu
First Name & Middle Initial & Last Name & Degree
Zhan Liang
12. IPD Sharing Statement
Plan to Share IPD
No
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