What this study is
Simplified from ClinicalTrials.govTesting a wearable resistance training device for the calf muscles used in walking (WearAPT) to see if it improves walking speed, distance, and ankle strength in adults age 60 and older.
Read the original summary from ClinicalTrials.gov
This project introduces and investigates the scientific premise that passive wearable therapeutic devices can enhance plantarflexor muscle performance during walking to elicit and promote lasting physiological and functional improvements for older adults. The investigators aim to quantify the preliminary efficacy of wearable plantarflexor resistance training to enhance gait performance in older adults, investigate neural and muscular mechanisms of adaptation, and identify target candidate characteristics for personalized treatment strategies. The investigators will test the hypothesis that, compared to baseline and unlike controls, WearAPT will increase peak ankle power output, stride length, habitual and maximum walking speeds, walking economy, and 6-min walk distance.
What's being tested
- Wearable Ankle Power Training (WearAPT)
Intervention · OTHER
Participants will complete two supervised, 20-min WearAPT sessions per week over the 6-week intervention period. Informed by a pilot study and designed to ensure a standardized starting point for all participants, all subjects will initially begin their first visit walking at their baseline preferred (self-selected) treadmill walking speed, and with 0 Nm of ankle resistive torque. The investigators will increase the resistance by 0.025 Nm/kg per minute, up to a maximum of 0.15 Nm/kg on the first session. On subsequent sessions, walking speed and resistance will be increased based on two evidence-based criteria monitored in 5-min intervals: (i) rate of perceived exertion (RPE) between 4 and 6, and (ii) a target heart rate indicative of moderate intensity activity (i.e., 50-70% maximum heart rate). The investigators will increase walking speed by 2.5% per session and resistive torque by 0.025 Nm/kg per week.
- Control
Intervention · OTHER
Participants randomly assigned to the control group will participate in pre- and post- laboratory visits and will complete a protocol of dose- (i.e., 20 min) and intensity-matched (i.e., heart rate) unresisted treadmill walking alone. Specifically, control participants will walk at a speed designed to elicit the same target within-session heart rate (i.e., 50-70% maximum).
Study details
- Sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Sedentary Behavior / Physical Inactivity · Aged
- Enrolling
- 72 people
- Starts
- 2027-01-01
- Est. completion
- 2030-03-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Insufficient weekly physical activity levels (i.e., ≤150 minutes moderate-intensity or ≤75 minutes vigorous-intensity activity)
- Self-select a habitual walking speed deemed indicative of age-related slowing (i.e., ≤1.1 m/s)
- Self-report at least some physical ability limitations (i.e., ≥4 on the "Stay Independent" questionnaire).
You can't join if
- Leg injury or fracture within the last 6 months
- Diagnosed anemia
- Neurological disorder of the legs such as peripheral neuropathy
- Vascular disorder of the legs such as peripheral arterial disease
- Taking medication that causes dizziness
- Cannot walk without an assistive aid (i.e., cane or walker)
- Mini Mental State Exam ≤25
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openBiomechatronics Laboratory
Flagstaff, Arizona, United States
- Zachary Lerner, PhD · Contact928-523-1787Zachary.Lerner@nau.edu
Applied Biomechanics Laboratory
Chapel Hill, North Carolina, United States
- Jason R Franz, PhD · Contact919-966-6119jrfranz@email.unc.edu
Study team
Sponsor
University of North Carolina, Chapel Hill
Study ID 26-2756
Principal investigator
Jason Franz, PhD
University of North Carolina, Chapel Hill
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.