Critical Illness, Intensive Care Unit Syndrome
Conditions
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).
Interventions
BEHAVIORALMove 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.
BEHAVIORALMove 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.
Sponsors
Society of Critical Care Medicine
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 handgrip strength | baseline, up to 30 days | Handgrip strength will be assessed using handgrip dynamometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of interventions completed | day 5 | Number of interventions completed will be assessed from self-reported exercise diary. |
Countries
United States
Outcome results
None listed