Move to Music Video Intervention for ICU Survivors

NCT04977297 | Completed

• 1 other identifier: 20201074
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness; Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change in handgrip strength

  Handgrip strength will be assessed using handgrip dynamometer.

  baseline, up to 30 days

Secondary Outcomes (3)

• Number of interventions completed

  day 5

• Patient Satisfaction Survey Scores

  day 5

• Exercise motivation as measured by the Physical Activity Enjoyment Scale

  day 5

Study Arms (2)

Move to Music Video Intervention

EXPERIMENTAL

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.

Behavioral: Move to Music -Video (M2M-V) Intervention

Move to Music Intervention

ACTIVE COMPARATOR

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.

Behavioral: Move to Music Intervention (M2M)

Interventions

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 Intervention

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.

Move to Music Video Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Society of Critical Care Medicine: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Methods

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Zhan Liang, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: July 26, 2021
• Study Start: February 10, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)