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Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk for deconditioning and functional decline. The primary aim of this study is to assess the functional impact of leg exercise during the pre-ambulation phase in patients undergoing ECMO.
The investigators are conducting this study to explore the impact of closed-chain leg exercise in individuals undergoing ECMO.
Aim 1: To determine if closed-chain leg exercise decreases the time to initial ambulation. The investgators hypothesize that adding leg exercise will decrease time to ambulation.
Aim 2: To determine the impact of closed chain leg exercise on functional ability. The investigators hypothesize that adding leg exercise will improve functional outcomes when added to an existing early mobilization program.
Aim 3: To determine the effect of closed chain leg exercise on hospital outcomes. The investigators hypothesize that hospital related outcomes will improve when leg exercise is added to an existing early mobilization program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Chain Leg Exercise | Active Comparator | Individuals in the open-chain group will progress through standard mobility progression. |
|
| Closed-Chain Leg Exercise | Experimental | Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-Chain Leg Exercise | Other | Individuals in the open-chain group will progress through standard mobility progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ambulation | Time to ambulation is measured as the number of days required for the participant to regain the ability to walk without the need for any kind of assistance. The unit of measure is days. | Baseline, to day 45 if applicable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda N LaLonde, DPT | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Chain Leg Exercise | Individuals in the open-chain group will progress through standard mobility progression. Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression. |
| FG001 | Closed-Chain Leg Exercise | Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-Chain Leg Exercise | Individuals in the open-chain group will progress through standard mobility progression. Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression. |
| BG001 | Closed-Chain Leg Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Ambulation | Time to ambulation is measured as the number of days required for the participant to regain the ability to walk without the need for any kind of assistance. The unit of measure is days. | One participant in closed-chain leg exercise group expired after signing the consent form. Baseline data for this participant is included in the baseline characteristics section. Interventional data was not collected for this participant. All participants for whom outcome measure was collected are included in this analysis. | Posted | Mean | Full Range | days | Baseline, to day 45 if applicable |
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Participants are monitored for adverse events for the length of the study, up to 45 days following initiation of ECMO treatment.
All participants were followed for adverse event collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-Chain Leg Exercise | Individuals in the open-chain group will progress through standard mobility progression. Open-Chain Leg Exercise: Individuals in the open-chain group will progress through standard mobility progression. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Sharp | University of Minnesota | (612) 626-4691 | sharp@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2016 | Jan 12, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2016 | Jan 12, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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24 total subjects will be recruited; 12 per group. Approximately 3-5 patients are admitted to UMMC each month who are undergoing ECMO and could be considered for study inclusion.
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| Closed-Chain Leg Exercise | Device | Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. |
|
|
Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Closed-Chain Leg Exercise | Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Closed-Chain Leg Exercise | Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. Closed-Chain Leg Exercise: Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform. | 1 | 2 | 0 | 2 | 0 | 2 |
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