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Clinical Trials/NCT04977297
NCT04977297CompletedNot Applicable

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

University of Miami2 sites in 1 country50 target enrollmentStarted: February 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Change in physical activity

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

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.

Change in handgrip strength

Time Frame: baseline, up to 30 days

Handgrip strength will be assessed using handgrip dynamometer.

Secondary Outcomes

  • Number of interventions completed(day 5)
  • Patient Satisfaction Survey Scores(day 5)
  • Exercise motivation as measured by the Physical Activity Enjoyment Scale(day 5)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhan Liang

Assistant Professor

University of Miami

Study Sites (2)

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