Peripheral Arterial Disease
Conditions
Brief summary
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.
Interventions
BEHAVIORALTreadwell Tredlr
Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.
Sponsors
Treadwell Therapeutics, Inc
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No Masking
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Be able to walk without an assistive aid (i.e., walker, cane) * Have the capacity the provide written informed consent * Have previously diagnosed peripheral arterial disease (by self-report)
Exclusion criteria
* Lower extremity injury or fracture within the last 6 months * Have a leg prosthesis * Prisoners * Individuals clearly lacking the capacity to provide informed consent * Vestibular impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overground Walking Speed After Intervention | Baseline, 6 weeks | Measured from the time taken to walk 6 meters. |
| Change in 6-min Walk Distance | Baseline, 6 weeks | Measured from the distance walked in 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stride Length | Baseline, 6 weeks | Measured using motion capture as the distance between heel markers across successive steps. |
| Change in Peak Ankle Power | Baseline, 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treadling Group Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. | 10 |
| Control Group Control Subjects continue their normal daily activities. | 7 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Stoppage Due to COVID-19 | 2 | 2 |
Baseline characteristics
| Characteristic | Treadling Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 72.6 years STANDARD_DEVIATION 5.4 | 71.3 years STANDARD_DEVIATION 5.2 | 72.2 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 |
| other Total, other adverse events | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
Primary
Change in 6-min Walk Distance
Measured from the distance walked in 6 minutes.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treadling Group | Change in 6-min Walk Distance | 13.60 m | Standard Deviation 52.6 |
| Control Group | Change in 6-min Walk Distance | 16.04 m | Standard Deviation 38.4 |
Primary
Change in Overground Walking Speed After Intervention
Measured from the time taken to walk 6 meters.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treadling Group | Change in Overground Walking Speed After Intervention | -0.046 m/s | Standard Deviation 0.099 |
| Control Group | Change in Overground Walking Speed After Intervention | 0.022 m/s | Standard Deviation 0.14 |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treadling Group | Change in Peak Ankle Power | -0.294 W/kg | Standard Deviation 0.63 |
| Control Group | Change in Peak Ankle Power | 0.088 W/kg | Standard Deviation 0.255 |
Secondary
Change in Stride Length
Measured using motion capture as the distance between heel markers across successive steps.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treadling Group | Change in Stride Length | 0.005 m | Standard Deviation 0.075 |
| Control Group | Change in Stride Length | -0.014 m | Standard Deviation 0.016 |