StrokeNCT05410600
Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke
A study testing Arm ergometer smart trainer cycling program in people with Stroke, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Arm ergometer smart trainer cycling program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 18 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke (RERC on Technologies to Promote Exercise and Health Among People With Disabilities)
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Arm ergometer smart trainer cycling program
- Keywords
- Exercise, Arm ergometer, Virtual environment, Disability
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm ergometer smart trainer cycling programOther
Arm ergometer exercise training using the smart trainer.
| Study group | Role | What they receive |
|---|---|---|
| Arm Ergometer Smart Trainer Cycling | Experimental | Participants will participate in an 8-week exercise training program using the smart trainer. Receives: Other: Arm ergometer smart trainer cycling program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (7)
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.
Measured: 8 weeks
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
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Grip Strength from Baseline to end of Week 8
Grip strength as measured using a hand dynamometer
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Mar 2023
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Rimmer, University of Alabama at Birmingham
- Investigators
- James H Rimmer, PhD, Principal investigator, UAB School of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410600
- Sponsor's protocol ID
- IRB-300009387
- Other IDs
- 90REGE000
- Status last verified
- Apr 2024
- First submitted
- 19 May 2022
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Trainer Arm Ergometry Exercise Training in Individuals Post-Stroke (RERC on Technologies to Promote Exercise and Health Among People With Disabilities)
- ClinicalTrials.gov ID
- NCT05410600
- Acronym / sponsor ID
- IRB-300009387
- Conditions
- Stroke
- Keywords
- Exercise, Arm ergometer, Virtual environment, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Ergometer Smart Trainer Cycling | Experimental | Other: Arm ergometer smart trainer cycling programParticipants will participate in an 8-week exercise training program using the smart trainer. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm ergometer smart trainer cycling programArm ergometer exercise training using the smart trainer. | Other | Arm Ergometer Smart Trainer Cycling |
Primary outcome
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
7 secondary outcomes
Stroke Severity from Baseline to end of Week 8
Time frame: 8 weeks
Cognitive Function from Baseline to end of Week 8
Time frame: 8 weeks
Quality of Life from Baseline to end of Week 8
Time frame: 8 weeks
Fatigue Severity from Baseline to end of Week 8
Time frame: 8 weeks
Grip Strength from Baseline to end of Week 8
Time frame: 8 weeks
Usability of the Smart Trainer at the end of Week 8
Time frame: 8 weeks
Participant feedback regarding the Smart Trainer Program at the end of Week 8
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James H Rimmer, PhD principal investigator
UAB School of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm ergometer smart trainer cycling program in people with Stroke, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen Consumption from Baseline to end of Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.