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Completed

NCT Number: NCT04977297

Move to Music Video 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).

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Key information

Conditions

Critical Illness Disease Attributes Intensive Care Unit Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Move to Music Intervention (M2M)

Behavioral

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

Behavioral

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 outcomes

  1. Change in global health

    Time frame: baseline, up to 30 days

    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.

  2. Change in physical activity

    Time frame: baseline, day5

    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.

  3. Change in handgrip strength

    Time frame: baseline, up to 30 days

    Handgrip strength will be assessed using handgrip dynamometer.

Secondary outcomes

  1. Number of interventions completed

    Time frame: day 5

    Number of interventions completed will be assessed from self-reported exercise diary.

  2. Patient Satisfaction Survey Scores

    Time frame: day 5

    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.

  3. Exercise motivation as measured by the Physical Activity Enjoyment Scale

    Time frame: day 5

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Society of Critical Care Medicine

Registry information

Official study title

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

Acronym: M2M-V

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2021
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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