Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Arm ergometer smart trainer cycling program

• Registration Number: NCT05410600
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-06-04
• Study First Posted: 2022-06-08
• Study Start: 2023-03-15
• Primary Completion: 2023-05-18
• Study Completion: 2023-05-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm Ergometer Smart Trainer Cycling	Arm ergometer smart trainer cycling program	Participants will participate in an 8-week exercise training program using the smart trainer.

Primary Outcome Measures

Name	Time	Method
Change in Oxygen Consumption from Baseline to end of Week 8	8 weeks	Oxygen consumption (VO2) as measured during a graded exercise test using a portable metabolic system

Secondary Outcome Measures

Name	Time	Method
Stroke Severity from Baseline to end of Week 8	8 weeks	NIH Stroke Scale Test. Scores range from 0 to 42. A higher score indicates greater functional impairment.
Cognitive Function from Baseline to end of Week 8	8 weeks	Mini-Mental State Exam. Scores range from 0 to 30, scores of 26 or higher indicate normal cognitive function
Fatigue Severity from Baseline to end of Week 8	8 weeks	Fatigue Severity Scale. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.
Usability of the Smart Trainer at the end of Week 8	8 weeks	System Usability Scale. Scores range from 0 to 100. Scores above 68 indicate above average usability. Scores below 68 point to issues with the design that need to be researched and resolved, while scores higher than 68 indicate the need for minor improvements to the design.
Quality of Life from Baseline to end of Week 8	8 weeks	Stroke Impact Scale. Scores range from 0 to 100, with higher scores indicating higher quality of life.
Participant feedback regarding the Smart Trainer Program at the end of Week 8	8 weeks	Semi-structured interview to capture participant feedback regarding the smart trainer exercise training program and ergometer.
Grip Strength from Baseline to end of Week 8	8 weeks	Grip strength as measured using a hand dynamometer

Trial Locations

Locations (1)

WHARF; 🇺🇸 Homewood, Alabama, United States