Move to Music Video Intervention for ICU Survivors

NCT ID: NCT04977297

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2023-10-01

Brief Summary

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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

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Conditions

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Critical Illness Intensive Care Unit Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Move to Music Video Intervention

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.

Group Type EXPERIMENTAL

Move to Music -Video (M2M-V) Intervention

Intervention Type 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 Intervention

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.

Group Type ACTIVE_COMPARATOR

Move to Music Intervention (M2M)

Intervention Type 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.

Interventions

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Move to Music Intervention (M2M)

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

Move to Music -Video (M2M-V) Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society of Critical Care Medicine

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Zhan Liang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhan Liang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20201074

Identifier Type: -

Identifier Source: org_study_id