About this trial
The purpose of this research is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Community-dwelling adult aged ≥65 years
Able to safely wear and use the WIM device
Willing to complete conventional and WIM-assisted treadmill walking
Able to provide informed consent and comply with study procedures
Disqualifiers
Recent hospitalization, surgery, fracture, or other medical condition that limits safe treadmill walking
Resting blood pressure, heart rate, or symptoms that meet protocol-defined safety exclusion criteria before exercise
Requires a cane, walker, or other assistive device for ambulation
Regular participation in structured aerobic exercise
Trial design
Parallel
Treatments tested in this trial
We Innovate Mobility (WIM) Device
DeviceWe Innovate Mobility (WIM) is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. Participants will walk on the treadmill three times per week for eight weeks while wearing the device.
Conventional Treadmill Walking
Other interventionParticipants will walk on the treadmill three times per week for eight weeks without assistance from the We Innovate Mobility (WIM) device.
Treatment groups
Trial outcomes
Primary outcomes
Change in Peak Oxygen Consumption
Change in peak oxygen consumption (VO2peak)
Secondary outcomes
Exercise Dose
Exercise dose is defined was walking duration x average treadmill speed x average treadmill grade
400 Meter Walk Time
Participants will be instructed to walk 400 meters at their usual fast pace without running, with standardized encouragement provided throughout the test. Participants will be permitted to slow down or rest briefly if needed for safety. Total completion time recorded. Participants will be permitted to slow down or rest briefly if needed for safety.
Expanded Short Physical Performance Battery (eSPPB)
eSPPB consists of 5 repeated chair stands, standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 6-meter walk to assess usual gait speed, and a narrow 6-meter walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). Total score range is 0-4 with a higher score indicating better performance.
PROMIS Fatigue Short Form 7a Survey
PROMIS Fatigue Short Form 7a measures the severity and functional impact of fatigue on everyday functioning. Total score range is 7-35 with a higher score indicating a higher level of fatigue.
Other outcomes
Oxygen Consumption Rate
Oxygen consumption rate of the peripheral blood mononuclear cells (PBMC) cells measured using respirometry.
Sponsors and contacts
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