Enhancing Rehabilitation in Aging Study (ERAS)

ConditionAdults

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age40-79

SponsorUniversity of Florida

About this trial

Acute Intermittent Hypoxia (AIH) is a rehab approach attributed to serotonin. AIH signaling also occurs via adenosine, and the pathways inhibit each other. Increased neural adenosine in aging may stymie AIH plasticity. The hypothesis is pre-treatment with adenosine 2A receptor inhibition (A2AI) enhances AIH effects on motor plasticity in unaffected adults. AIH exposures will be paired with A2AI or placebo, with a 4-week washout. Primary outcome measures include inspiratory and grip strength.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 40-79 years Non-smokers Ambulatory in the community Do not require assistance to complete activities of daily living

Disqualifiers

Restrictive or obstructive lung conditions Pregnancy Active respiratory infections Use of antibiotics in the last 4 weeks Symptomatic cardiac disease BMI >35 kg/m2 Seizure disorder or progressive neurological condition Uses positive pressure mechanical ventilation when awake and upright, or oxygen assistance at any time

Trial design

Design model

Crossover

Treatments tested in this trial

Istradefylline 20 mg
Drug
Participants will receive 20 mg istradefylline active treatment, followed by acute intermittent hypoxia
Placebo
Drug
Participants will receive a methylcellulose capsule identical in appearance to the active treatment, followed by acute intermittent hypoxia
Acute Intermittent Hypoxia (AIH)
Other intervention
Short periods (\~1 minute) of breathing lower-oxygen gas, separated by periods (\~1 minute) of breathing normal oxygen air.

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: AIH + placeboPlacebo comparator 2 interventions

Group B: AIH + IstradefyllineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Maximal Inspiratory Pressure

Most negative pressure generated during a maximal inspiratory effort.

Time frame

From enrollment to a 3-week follow-up.

Maximal grip force

Highest tension generated by the flexor muscles of the hand during a maximal grip.

Time frame

From enrollment to a 3-week follow up.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: