Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 2

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • We Innovate Mobility (WIM) Device

    Device

    We 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 intervention

    Participants will walk on the treadmill three times per week for eight weeks without assistance from the We Innovate Mobility (WIM) device.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: We Innovate Mobility (WIM)-Assisted Treadmill WalkingExperimental treatment 1 intervention
Group B: Conventional Treadmill WalkingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Peak Oxygen Consumption

Change in peak oxygen consumption (VO2peak)

Time frame
From baseline to week 8

Secondary outcomes

1

Exercise Dose

Exercise dose is defined was walking duration x average treadmill speed x average treadmill grade

Time frame
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
2

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.

Time frame
Baseline and Week 8
3

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.

Time frame
Baseline and Week 8
4

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.

Time frame
Baseline and Week 8

Other outcomes

1

Oxygen Consumption Rate

Oxygen consumption rate of the peripheral blood mononuclear cells (PBMC) cells measured using respirometry.

Time frame
Baseline and Week 8

Sponsors and contacts

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