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COVID-19 continues to prevent recruitment of people over the age of 65 years.
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| Name | Class |
|---|---|
| Treadwell Therapeutics, Inc | INDUSTRY |
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This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadling Group | Experimental | Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. |
|
| Control Group | No Intervention | Control Subjects continue their normal daily activities. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadwell Tredlr | Behavioral | Complete treadling exercise 3x per week (15 min sessions) for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overground Walking Speed After Intervention | Measured from the time taken to walk 6 meters. | Baseline, 6 weeks |
| Change in 6-min Walk Distance | Measured from the distance walked in 6 minutes. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stride Length | Measured using motion capture as the distance between heel markers across successive steps. | Baseline, 6 weeks |
| Change in Peak Ankle Power | Measured using motion capture and instrumented treadmill forces as the peak positive power generated by the calf muscles during the push-off phase of walking. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Franz, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Biomechanics Laboratory | Chapel Hill | North Carolina | 27514 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
Beginning 9 to 36 months following publication.
The investigator who proposes to use the data must have approval from an IRB, IEC, or REB, as applicable, and execute a data use/sharing agreement with the University of North Carolina at Chapel Hill.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treadling Group | Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. |
| FG001 | Control Group | Control Subjects continue their normal daily activities. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treadling Group | Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. |
| BG001 | Control Group | Control Subjects continue their normal daily activities. |
| 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 | Change in Overground Walking Speed After Intervention | Measured from the time taken to walk 6 meters. | Posted | Mean | Standard Deviation | m/s | Baseline, 6 weeks |
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From the time of enrollment through the completion of the second laboratory session (i.e., post-test), approximately 6 weeks after the first laboratory session (i.e., baseline)
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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 | Treadling Group | Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason R Franz, PhD | University of North Carolina at Chapel Hill | 919-966-6119 | jrfranz@email.unc.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 26, 2018 | Oct 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Subjects will be randomized into a treadling group (n=15) or a control group (n=15). Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. The control group will be instructed to continue their normal daily activities.
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No Masking
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| Baseline, 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| Primary | Change in 6-min Walk Distance | Measured from the distance walked in 6 minutes. | Posted | Mean | Standard Deviation | m | Baseline, 6 weeks |
|
|
|
| Secondary | Change in Stride Length | Measured using motion capture as the distance between heel markers across successive steps. | Posted | Mean | Standard Deviation | m | Baseline, 6 weeks |
|
|
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| Secondary | Change in Peak Ankle Power | Measured using motion capture and instrumented treadmill forces as the peak positive power generated by the calf muscles during the push-off phase of walking. | Posted | Mean | Standard Deviation | W/kg | Baseline, 6 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control Group | Control Subjects continue their normal daily activities. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |