Critical IllnessM2M-VNCT04977297
Move to Music Video Intervention for ICU Survivors
A study testing Move to Music Intervention (M2M) and Move to Music -Video (M2M-V) Intervention in people with Critical Illness and Intensive Care Unit Syndrome, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care Unit Syndrome
- What is being tested?
- Move to Music Intervention (M2M) and Move to Music -Video (M2M-V) Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Move to Music Video Intervention - A Music and Video Guided Exercise Intervention for ICU Survivors
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
- Being tested
- Move to Music Intervention (M2M), Move to Music -Video (M2M-V) Intervention
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Move to Music Intervention (M2M)Behavioural
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 -Video (M2M-V) InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Move to Music Intervention (M2M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, day5
Change in handgrip strength
Handgrip strength will be assessed using handgrip dynamometer.
Measured: baseline, up to 30 days
Secondary outcomes (3)
Number of interventions completed
Number of interventions completed will be assessed from self-reported exercise diary.
Measured: day 5
Patient Satisfaction Survey Scores
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.
Measured: day 5
Exercise motivation as measured by the Physical Activity Enjoyment Scale
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.
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start10 Feb 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Responsible party
- Principal investigator, Zhan Liang, University of Miami
- Investigators
- Zhan Liang, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977297
- Sponsor's protocol ID
- 20201074
- Acronym
- M2M-V
- Status last verified
- Nov 2023
- First submitted
- 12 May 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move to Music Video Intervention - A Music and Video Guided Exercise Intervention for ICU Survivors
- ClinicalTrials.gov ID
- NCT04977297
- Acronym / sponsor ID
- M2M-V / 20201074
- Conditions
- Critical Illness, Intensive Care Unit Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Move to Music Video Intervention | Experimental | Behavioral: Move to Music -Video (M2M-V) InterventionParticipants 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. |
| Move to Music Intervention | Active comparator | Behavioral: Move to Music Intervention (M2M)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Move to Music Intervention |
| Move to Music -Video (M2M-V) InterventionThe 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. | Behavioural | Move to Music Video Intervention |
Primary outcome
Change in global health
Time frame: 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
Time frame: 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
Time frame: baseline, up to 30 days
Handgrip strength will be assessed using handgrip dynamometer.
3 secondary outcomes
Number of interventions completed
Time frame: day 5
Patient Satisfaction Survey Scores
Time frame: day 5
Exercise motivation as measured by the Physical Activity Enjoyment Scale
Time frame: day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhan Liang, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Move to Music Intervention (M2M) and Move to Music -Video (M2M-V) Intervention in people with Critical Illness and Intensive Care Unit Syndrome, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global health (time frame: baseline, up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.