NCT05410600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

May 19, 2022

Last Update Submit

April 24, 2024

Conditions

Stroke

Keywords

ExerciseArm ergometerVirtual environmentDisability

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Secondary Outcomes (7)

  • Stroke Severity from Baseline to end of Week 8

    8 weeks

  • Cognitive Function from Baseline to end of Week 8

    8 weeks

  • Quality of Life from Baseline to end of Week 8

    8 weeks

  • Fatigue Severity from Baseline to end of Week 8

    8 weeks

  • Grip Strength from Baseline to end of Week 8

    8 weeks

  • +2 more secondary outcomes

Study Arms (1)

Arm Ergometer Smart Trainer Cycling

EXPERIMENTAL

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

Other: Arm ergometer smart trainer cycling program

Interventions

Arm ergometer smart trainer cycling programOTHER

Arm ergometer exercise training using the smart trainer.

Arm Ergometer Smart Trainer Cycling

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WHARF

Homewood, Alabama, 35209, United States

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • James H Rimmer, PhD

    UAB School of Health Professions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2022

First Posted

June 8, 2022

Study Start

March 15, 2023

Primary Completion

May 18, 2023

Study Completion

May 18, 2023

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

US(1)