Critical IllnessNCT03885687
Exercise With Music for ICU Survivors
A study testing Exercise with Music and Exercise in people with Critical Illness and Intensive Care Unit Syndrome, run by University of Miami at 1 site in United States.
Trial summary
This project will test whether the individualized music-enhanced exercise playlist (Exercise with Music intervention) can prevent further physical and psychological deterioration and motivate ICU survivors to more actively participate in their rehabilitation. 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?
- Exercise with Music and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2019to 1 Aug 2019
- 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)
- within 72 hours of ICU discharge (standardizes time to begin intervention)
- ability to independently move upper and lower extremities (required to participate in intervention)
- ability to speak English or Spanish
Who cannot join
- documented mental incompetence
- dependent status pre-ICU admission (KATZ, activity daily living scale)
- evidence of delirium using the Confusion Assessment Method (CAM)
- hearing impairment
- documented "comfort measures only" in the electronic medical record
- prior residence in a long-term care facility
- unstable hemodynamics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise With Music Program for ICU Survivors
This project will test whether the individualized music-enhanced exercise playlist (Exercise with Music intervention) can prevent further physical and psychological deterioration and motivate ICU survivors to more actively participate in their rehabilitation.
- Conditions
- Critical Illness, Intensive Care Unit Syndrome
- Being tested
- Exercise with Music, Exercise
- Keywords
- Rehabilitation, Exercise, Music Intervention
- Medical subject headings
- Critical Illness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with MusicBehavioural
The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity.
ExerciseBehavioural
The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Exercise with Music Intervention | Experimental | The Exercise with Music intervention is a recorded exercise playlist, which is tailored to a patient's individual physical abilities and music choices. Receives: Behavioral: Exercise with Music |
| Active Control Group | Active comparator | The active control group will receive exercise brochure and will be advised to exercise at least twice daily. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Number of subjects enrolled into the study divided by number of subjects approached X 100%
Measured: One year
Acceptability of intervention as measured by a questionnaire
A self-designed 8-item questionnaire is administered to assess subjects' feedback regarding the intervention. Five questions are likert-scale questions (strongly disagree, disagree, undecided, agree, strongly agree); three questions are yes or no questions. If the results of the questionnaire show that majority of patients answer "agree or strongly agree" and "yes", this would indicate that the intervention is acceptable. If the results of the questionnaire show that majority of the patients answer "strongly disagree or disagree" and "no", this would indicate that the intervention is not acceptable.
Measured: Day five
Number of participants that complete the intervention as prescribed
Count of participants who exercise twice daily for five days (upper and lower extremity exercise). Each session includes five movements. The number of movements and sessions of the intervention delivered within and beyond the 5-day mandatory regimen will be documented.
Measured: Day 5
Number of participants that complete the intervention beyond the 5-day mandatory sessions
Count of participants who complete additional exercise sessions beyond the prescribed exercise regimen (twice daily for five days). Each session includes five movements.
Measured: Day 11
Number of participants with adverse events
Adverse events are any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.
Measured: Day 5
Secondary outcomes (14)
Effect size of the Exercise with Music intervention
Estimated effect size of the intervention on outcome measures to calculate sample size for a larger future study.
Measured: One year
Changes in activity
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. It contains an accelerometer that is capable of sensing any motion with minimal acceleration of 0.01g to measure long-term gross motor activity and intensity of motion.
Measured: Baseline, Day 5
Changes grip strength
Grip strength will be assessed using handgrip dynamometer.
Measured: Baseline, Day 5
Changes grip strength at hospital discharge
Grip strength will be assessed using handgrip dynamometer.
Measured: Day 5, Day 11
Changes in Foot Strength
Foot strength will be assessed objectively using hand-held dynamometer.
Measured: Baseline, Day 5
Changes in Foot Strength at hospital discharge
Foot strength will be assessed objectively using hand-held dynamometer.
Measured: Day 5, Day 11
Changes in Motivation (Visual Analog Scale)
Motivation will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "not motivated to do exercise at all"; "100" indicates "extremely motivated to do exercise".
Measured: Baseline, Day 5
Changes in Motivation (Visual Analog Scale) at hospital discharge
Motivation will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "not motivated to do exercise at all"; "100" indicates "extremely motivated to do exercise".
Measured: Day 5, Day 11
Changes in Anxiety (Visual Analog Scale)
Anxiety will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "no anxiety"; "100" indicates "extremely anxious".
Measured: Baseline, Day 5
Changes in Anxiety (Visual Analog Scale) at hospital discharge
Anxiety will be measured by the visual analog scale (VAS) with scores from 0 to 100. "0" indicates "no anxiety"; "100" indicates "extremely anxious".
Measured: Day 5, Day 11
Changes in Anxiety (NIH Toolbox)
Anxiety will also be assessed using the NIH Toolbox Emotion Battery (fear-affect survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always." The survey is scored using IRT methods. Higher scores are indicative of more feelings of anxiety.
Measured: Baseline, day 5
Changes in Anxiety (NIH Toolbox) at hospital discharge
Anxiety will also be assessed using the NIH Toolbox Emotion Battery (fear-affect survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always." The survey is scored using IRT methods. Higher scores are indicative of more feelings of anxiety.
Measured: Day 5, Day 11
Changes in Depression (NIH Toolbox)
Depression will be assessed using the NIH Toolbox Emotion Battery (sadness survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always" (adults) or "almost always". higher scores are indicative of more depressive.
Measured: Baseline, Day 5
Changes in Depression (NIH Toolbox) at hospital discharge
Depression will be assessed using the NIH Toolbox Emotion Battery (sadness survey), CAT format. Each item administered has a 5-point scale with options ranging from "never" to "always" (adults) or "almost always". higher scores are indicative of more depressive.
Measured: Day 5, Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start5 Mar 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhan Liang, University of Miami
- Investigators
- Zhan Liang, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885687
- Sponsor's protocol ID
- 20180508
- Status last verified
- Jun 2020
- First submitted
- 6 Dec 2018
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liang Z, Munro C, Yip H, Ji M, Sena Moore K, Ferreira T, Signorile JF, Pan Y. Randomized Controlled Study of Self-Managed Music-Guided Exercise Intervention Following Intensive Care. Nurs Res. 2023 May-Jun 01;72(3):193-199. doi: 10.1097/NNR.0000000000000644. Epub 2023 Jan 9.
PubMed 36638206Liang Z, Yip H, Sena Moore K, Ferreira T, Ji M, Signorile JF, Munro C. Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors-A Pilot Randomized Controlled Study. Biol Res Nurs. 2022 Apr;24(2):145-151. doi: 10.1177/10998004211050297. Epub 2021 Nov 5.
PubMed 34738474
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise With Music Program for ICU Survivors
- ClinicalTrials.gov ID
- NCT03885687
- Acronym / sponsor ID
- 20180508
- Conditions
- Critical Illness, Intensive Care Unit Syndrome
- Keywords
- Rehabilitation, Exercise, Music Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 22 Mar 2019 (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.
This project will test whether the individualized music-enhanced exercise playlist (Exercise with Music intervention) can prevent further physical and psychological deterioration and motivate ICU survivors to more actively participate in their rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise with Music Intervention | Experimental | Behavioral: Exercise with MusicThe Exercise with Music intervention is a recorded exercise playlist, which is tailored to a patient's individual physical abilities and music choices. |
| Active Control Group | Active comparator | Behavioral: ExerciseThe active control group will receive exercise brochure and will be advised to exercise at least twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years old
- length of ICU stay >5 days (excludes patients with less comorbidity)
- within 72 hours of ICU discharge (standardizes time to begin intervention)
- ability to independently move upper and lower extremities (required to participate in intervention)
- ability to speak English or Spanish
Key exclusion criteria (7 listed)
- documented mental incompetence
- dependent status pre-ICU admission (KATZ, activity daily living scale)
- evidence of delirium using the Confusion Assessment Method (CAM)
- hearing impairment
- documented "comfort measures only" in the electronic medical record
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 |
|---|---|---|
| Exercise with MusicThe Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity. | Behavioural | Exercise with Music Intervention |
| ExerciseThe exercise group will receive exercise brochure and will be advised to exercise at least twice daily. | Behavioural | Active Control Group |
Primary outcome
Enrollment rate
Time frame: One year
Number of subjects enrolled into the study divided by number of subjects approached X 100%
Acceptability of intervention as measured by a questionnaire
Time frame: Day five
A self-designed 8-item questionnaire is administered to assess subjects' feedback regarding the intervention. Five questions are likert-scale questions (strongly disagree, disagree, undecided, agree, strongly agree); three questions are yes or no questions. If the results of the questionnaire show that majority of patients answer "agree or strongly agree" and "yes", this would indicate that the intervention is acceptable. If the results of the questionnaire show that majority of the patients answer "strongly disagree or disagree" and "no", this would indicate that the intervention is not acceptable.
Number of participants that complete the intervention as prescribed
Time frame: Day 5
Count of participants who exercise twice daily for five days (upper and lower extremity exercise). Each session includes five movements. The number of movements and sessions of the intervention delivered within and beyond the 5-day mandatory regimen will be documented.
Number of participants that complete the intervention beyond the 5-day mandatory sessions
Time frame: Day 11
Count of participants who complete additional exercise sessions beyond the prescribed exercise regimen (twice daily for five days). Each session includes five movements.
Number of participants with adverse events
Time frame: Day 5
Adverse events are any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.
14 secondary outcomes
Effect size of the Exercise with Music intervention
Time frame: One year
Changes in activity
Time frame: Baseline, Day 5
Changes grip strength
Time frame: Baseline, Day 5
Changes grip strength at hospital discharge
Time frame: Day 5, Day 11
Changes in Foot Strength
Time frame: Baseline, Day 5
Changes in Foot Strength at hospital discharge
Time frame: Day 5, Day 11
Changes in Motivation (Visual Analog Scale)
Time frame: Baseline, Day 5
Changes in Motivation (Visual Analog Scale) at hospital discharge
Time frame: Day 5, Day 11
Changes in Anxiety (Visual Analog Scale)
Time frame: Baseline, Day 5
Changes in Anxiety (Visual Analog Scale) at hospital discharge
Time frame: Day 5, Day 11
Changes in Anxiety (NIH Toolbox)
Time frame: Baseline, day 5
Changes in Anxiety (NIH Toolbox) at hospital discharge
Time frame: Day 5, Day 11
Changes in Depression (NIH Toolbox)
Time frame: Baseline, Day 5
Changes in Depression (NIH Toolbox) at hospital discharge
Time frame: Day 5, Day 11
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 29 Jun 2020.
- Derived from this study: PubMed 36638206Liang Z, Munro C, Yip H, Ji M, Sena Moore K, Ferreira T, Signorile JF, Pan Y. Randomized Controlled Study of Self-Managed Music-Guided Exercise Intervention Following Intensive Care. Nurs Res. 2023 May-Jun 01;72(3):193-199. doi: 10.1097/NNR.0000000000000644. Epub 2023 Jan 9.
- Derived from this study: PubMed 34738474Liang Z, Yip H, Sena Moore K, Ferreira T, Ji M, Signorile JF, Munro C. Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors-A Pilot Randomized Controlled Study. Biol Res Nurs. 2022 Apr;24(2):145-151. doi: 10.1177/10998004211050297. Epub 2021 Nov 5.
- 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 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 Exercise with Music and Exercise 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 5 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 29 Jun 2020. 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?
Enrollment rate (time frame: One year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885687, which also lists 2 linked publications.
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 29 Jun 2020.