Move to Music Video Intervention for ICU Survivors (M2M-V)

University of Miami

Status: Completed

Conditions: Critical Illness; Intensive Care Unit Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04977297

20201074

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Move to Music Video Intervention

Experimental group

Description:

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.

Treatment:

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

Move to Music Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Move to Music Intervention (M2M)