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OpenTrials
Completed

NCT Number: NCT05410600

Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WHARF

Homewood, Alabama, 35209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm ergometer smart trainer cycling program

Other

Arm ergometer exercise training using the smart trainer.

Primary outcomes

  1. Change in Oxygen Consumption from Baseline to end of Week 8

    Time frame: 8 weeks

    Oxygen consumption (VO2) as measured during a graded exercise test using a portable metabolic system

Secondary outcomes

  1. Stroke Severity from Baseline to end of Week 8

    Time frame: 8 weeks

    NIH Stroke Scale Test. Scores range from 0 to 42. A higher score indicates greater functional impairment.

  2. Cognitive Function from Baseline to end of Week 8

    Time frame: 8 weeks

    Mini-Mental State Exam. Scores range from 0 to 30, scores of 26 or higher indicate normal cognitive function

  3. Quality of Life from Baseline to end of Week 8

    Time frame: 8 weeks

    Stroke Impact Scale. Scores range from 0 to 100, with higher scores indicating higher quality of life.

  4. Fatigue Severity from Baseline to end of Week 8

    Time frame: 8 weeks

    Fatigue Severity Scale. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.

  5. Grip Strength from Baseline to end of Week 8

    Time frame: 8 weeks

    Grip strength as measured using a hand dynamometer

  6. Usability of the Smart Trainer at the end of Week 8

    Time frame: 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.

  7. Participant feedback regarding the Smart Trainer Program at the end of Week 8

    Time frame: 8 weeks

    Semi-structured interview to capture participant feedback regarding the smart trainer exercise training program and ergometer.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke (RERC on Technologies to Promote Exercise and Health Among People With Disabilities)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2022
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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