Covid19REMMHIIT-COVIDNCT04664101
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
A study testing REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) and Comparator in people with Covid19 and Critical Illness, run by Duke University at 2 sites in United States.
Trial summary
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Critical Illness, High Intensity Interval Training
- What is being tested?
- REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) and Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2022to 1 Dec 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
- ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring intubation and mechanical ventilation for > 48 hours with an ICU length of stay of ≥ 4 days.
- Ability to ambulate with or without a gait aid prior to hospital discharge
- Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
Who cannot join
- Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
- Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)
- Unable or unwilling to follow coaching via mobile-health iPhone interaction
- Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to:
- Recent (< 5 days) acute primary cardiac event
- Unstable Angina
Show all 11Show fewer
- Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
- Symptomatic aortic stenosis
- Uncontrolled symptomatic heart failure
- Acute myocarditis or pericarditis
- Suspected or known dissecting aneurysm
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Vanderbilt University
Nashville, Tennessee, 37232
About this study
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)
Read the detailed description
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT to improve recovery after Intensive Care Unit (ICU) discharge in patients with COVID-19 (REMM-HIIT-ICU-COVID) will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, Mhealth-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.
- Conditions
- Covid19, Critical Illness, High Intensity Interval Training, ICU, Intensive Care Units, Fitness Trackers
- Being tested
- REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT), Comparator
- Keywords
- critical care, Covid19, ICU, high intensity interval training, intensive care unit, critical illness, fitness trackers
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)Behavioural
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching.
ComparatorOther
Patients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted
| Study group | Role | What they receive |
|---|---|---|
| REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) | Experimental | REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching. Receives: Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) |
| Comparator | Other | Patients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (V02P) at 3 months after hospital discharge
Measured: 3 months post-discharge
Secondary outcomes (17)
Change in 6 minute walk test distance from baseline to 3 months after hospital discharge
distance walked in 6 minutes
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in muscle mass from baseline to 3 months after hospital discharge
Measured by muscle sound
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in muscle strength from baseline to 3 months after hospital discharge
Measured by Fried Frailty (includes Hand Grip strength)
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in muscle strength from baseline to 3 months after hospital discharge
Measured by quadriceps strength (Quadricep muscle dynamometry)
Measured: Hospital discharge (baseline), 3 months post-discharge
Cognition at 3 months after hospital discharge
Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Measured: 3 months post-discharge
Change in cognition from baseline to 3 months after hospital discharge.
Measured by Montreal Cognitive Assessment (MOCA)
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in cognition from baseline to 3 months after hospital discharge.
Measured by Hayling Sentence Completion
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in cognition from baseline to 3 months after hospital discharge.
Measured by PROMIS Cognitive function
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in cognition from 3 months to 6 months after hospital discharge.
Measured by PROMIS Cognitive function
Measured: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by Sociodemographic survey
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by Employment Survey
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by EQ-5D-5L
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by Katz ADL/ Lawton IADL
Measured: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by Sociodemographic Survey
Measured: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by Employment Survey
Measured: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by EQ-5D-5L
Measured: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by Katz ADL/ Lawton IADL
Measured: 3 months post-discharge, 6 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start2 Mar 2022
- Primary completion1 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664101
- Sponsor's protocol ID
- Pro00105798
- Acronym
- REMMHIIT-COVID
- Status last verified
- Jan 2024
- First submitted
- 10 Dec 2020
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
- ClinicalTrials.gov ID
- NCT04664101
- Acronym / sponsor ID
- REMMHIIT-COVID / Pro00105798
- Conditions
- Covid19, Critical Illness, High Intensity Interval Training, ICU, Intensive Care Units, Fitness Trackers
- Keywords
- critical care, Covid19, ICU, high intensity interval training, intensive care unit, critical illness, fitness trackers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 11 Dec 2020 (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.
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)
Detailed description
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT to improve recovery after Intensive Care Unit (ICU) discharge in patients with COVID-19 (REMM-HIIT-ICU-COVID) will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, Mhealth-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) | Experimental | Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching. |
| Comparator | Other | Other: ComparatorPatients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years
- ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring intubation and mechanical ventilation for > 48 hours with an ICU length of stay of ≥ 4 days.
- Ability to ambulate with or without a gait aid prior to hospital discharge
- Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
Key exclusion criteria (11 listed)
- Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
- Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)
- Unable or unwilling to follow coaching via mobile-health iPhone interaction
- Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to:
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 |
|---|---|---|
| REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching. | Behavioural | REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) |
| ComparatorPatients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted | Other | Comparator |
Primary outcome
Peak oxygen consumption (V02P) at 3 months after hospital discharge
Time frame: 3 months post-discharge
17 secondary outcomes
Change in 6 minute walk test distance from baseline to 3 months after hospital discharge
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in muscle mass from baseline to 3 months after hospital discharge
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in muscle strength from baseline to 3 months after hospital discharge
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in muscle strength from baseline to 3 months after hospital discharge
Time frame: Hospital discharge (baseline), 3 months post-discharge
Cognition at 3 months after hospital discharge
Time frame: 3 months post-discharge
Change in cognition from baseline to 3 months after hospital discharge.
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in cognition from baseline to 3 months after hospital discharge.
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in cognition from baseline to 3 months after hospital discharge.
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in cognition from 3 months to 6 months after hospital discharge.
Time frame: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months after hospital discharge.
Time frame: Hospital discharge (baseline), 3 months post-discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Time frame: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Time frame: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Time frame: 3 months post-discharge, 6 months post-hospital discharge
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Time frame: 3 months post-discharge, 6 months post-hospital discharge
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 18 Jan 2024.
- 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.
Paul Wischmeyer, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) and Comparator in people with Covid19 and Critical Illness, run by Duke University at 2 sites 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 4 inclusion and 11 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Peak oxygen consumption (V02P) at 3 months after hospital discharge (time frame: 3 months post-discharge). 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 18 Jan 2024.