Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05410600
Collaborator
(none)
6
1
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Arm ergometer smart trainer cycling program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke (RERC on Technologies to Promote Exercise and Health Among People With Disabilities)
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm Ergometer Smart Trainer Cycling

Participants will participate in an 8-week exercise training program using the smart trainer.

Other: Arm ergometer smart trainer cycling program
Arm ergometer exercise training using the smart trainer.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Grip Strength from Baseline to end of Week 8 [8 weeks]

    Grip strength as measured using a hand dynamometer

  6. 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.

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: James H Rimmer, PhD, UAB School of Health Professions

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Rimmer, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05410600
Other Study ID Numbers:
  • IRB-300009387
First Posted:
Jun 8, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by James Rimmer, Professor, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022