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Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm ergometer smart trainer cycling program
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Exercise, Arm ergometer, Virtual environment, Disability

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • WHARF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Ergometer Smart Trainer Cycling

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stroke Severity from Baseline to end of Week 8
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
Mini-Mental State Exam. Scores range from 0 to 30, scores of 26 or higher indicate normal cognitive function
Quality of Life from Baseline to end of Week 8
Stroke Impact Scale. Scores range from 0 to 100, with higher scores indicating higher quality of life.
Fatigue Severity from Baseline to end of Week 8
Fatigue Severity Scale. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.
Grip Strength from Baseline to end of Week 8
Grip strength as measured using a hand dynamometer
Usability of the Smart Trainer at the end of Week 8
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.
Participant feedback regarding the Smart Trainer Program at the end of Week 8
Semi-structured interview to capture participant feedback regarding the smart trainer exercise training program and ergometer.

Full Information

First Posted
May 19, 2022
Last Updated
September 23, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05410600
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Exercise, Arm ergometer, Virtual environment, Disability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Ergometer Smart Trainer Cycling
Arm Type
Experimental
Arm Description
Participants will participate in an 8-week exercise training program using the smart trainer.
Intervention Type
Other
Intervention Name(s)
Arm ergometer smart trainer cycling program
Intervention Description
Arm ergometer exercise training using the smart trainer.
Primary Outcome Measure Information:
Title
Change in Oxygen Consumption from Baseline to end of Week 8
Description
Oxygen consumption (VO2) as measured during a graded exercise test using a portable metabolic system
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Stroke Severity from Baseline to end of Week 8
Description
NIH Stroke Scale Test. Scores range from 0 to 42. A higher score indicates greater functional impairment.
Time Frame
8 weeks
Title
Cognitive Function from Baseline to end of Week 8
Description
Mini-Mental State Exam. Scores range from 0 to 30, scores of 26 or higher indicate normal cognitive function
Time Frame
8 weeks
Title
Quality of Life from Baseline to end of Week 8
Description
Stroke Impact Scale. Scores range from 0 to 100, with higher scores indicating higher quality of life.
Time Frame
8 weeks
Title
Fatigue Severity from Baseline to end of Week 8
Description
Fatigue Severity Scale. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.
Time Frame
8 weeks
Title
Grip Strength from Baseline to end of Week 8
Description
Grip strength as measured using a hand dynamometer
Time Frame
8 weeks
Title
Usability of the Smart Trainer at the end of Week 8
Description
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.
Time Frame
8 weeks
Title
Participant feedback regarding the Smart Trainer Program at the end of Week 8
Description
Semi-structured interview to capture participant feedback regarding the smart trainer exercise training program and ergometer.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Rimmer, PhD
Organizational Affiliation
UAB School of Health Professions
Official's Role
Principal Investigator
Facility Information:
Facility Name
WHARF
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

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Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke

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