Clinical trial NCT05410600: Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke
Official title: Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke (RERC on Technologies to Promote Exercise and Health Among People With Disabilities)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Exercise
Arm ergometer
Virtual environment
Disability
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 1
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The smart trainer ergometer is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways. The purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals with post-stroke limb impairment.

Detailed description: Individuals with physical disabilities show much lower rates of exercise participation than their able-bodied peers. Much of the reason for the low rates of activity among this population comes from the presence of barriers. Lack of motivation, lack of transportation, lack of accessible facilities and equipment, and cost are all factors that discourage exercise participation among those with disabilities. Based on these factors, there is a need for accessible enjoyable exercise options for people with physical disabilities. The smart trainer ergometer (also known as the Advanced Virtual Exercise Environment Device) is comprised of an ergometer with foot and hand pedals, and a visual display in front of the user that can show a variety of scenic pathways.

In our previous protocol (IRB-300001384) we explored the power output curves of people post stroke compared with non-impaired individuals during one arm versus two arm cycling exercise using the smart trainer arm ergometer. The work demonstrated the potential benefit of interactive exercise for those with physical disabilities. The purpose of this study is to examine changes in power output, oxygen consumption, cognitive function, and quality of life after 8 weeks of smart trainer arm ergometry exercise training among individuals who have a stroke-based limb impairment.

Eligibility criteria: Inclusion Criteria:

* Males and females post-stroke
* Age 40-70 years
* Able to use both arms during arm cycling exercise (i.e., able to complete the 10 revolution pre-test)

Exclusion Criteria:

* Younger than 40 and older than 70 years
* No movement in one arm or have an injury that prevents safe use of one arm during exercise
* Unable to complete the 10 revolution pre-test
* Unstable cardiovascular conditions
* Unable to understand study directions

Primary outcomes:
measure: Change in Oxygen Consumption from Baseline to end of Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Stroke Severity from Baseline to end of Week 8
timeFrame: 8 weeks
measure: Cognitive Function from Baseline to end of Week 8
timeFrame: 8 weeks
measure: Quality of Life from Baseline to end of Week 8
timeFrame: 8 weeks
measure: Fatigue Severity from Baseline to end of Week 8
timeFrame: 8 weeks
measure: Grip Strength from Baseline to end of Week 8
timeFrame: 8 weeks
measure: Usability of the Smart Trainer at the end of Week 8
timeFrame: 8 weeks
measure: Participant feedback regarding the Smart Trainer Program at the end of Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Homewood
country: United States
facility: WHARF
state: Alabama
Study officials:
affiliation: UAB School of Health Professions
name: James H Rimmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: