Move to Music Video Intervention for ICU Survivors

Not Applicable

Completed

• Conditions: Critical Illness; Intensive Care Unit Syndrome

• Registration Number: NCT04977297
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Study Start: 2022-02-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in physical activity	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	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	baseline, up to 30 days	Handgrip strength will be assessed using handgrip dynamometer.

Secondary Outcome Measures

Name	Time	Method
Number of interventions completed	day 5	Number of interventions completed will be assessed from self-reported exercise diary.
Patient Satisfaction Survey Scores	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.
Exercise motivation as measured by the Physical Activity Enjoyment Scale	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States