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Exercise Intensity and Video Games: Persons Post-stroke

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT04538326
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
16
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Persons post stroke executed stepping activities under four conditions: standard of care, interacting with: an off-the-shelf Microsoft-Kinect game, with a self-paced repeated custom video game and a game-paced random custom video game. Exercise intensity (neuromuscular and cardiovascular), enjoyment and perceived effort were measured during and after each condition.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
 N/A

Detailed Description

Persons post stroke were first familiarized with the four exercise conditions and then instrumented with a metabolic system and heart rate sensor. They played the games in two counter balanced blocks: repeated (standard of care and self-paced repeated custom) and random (Microsoft-Kinect game and game-paced random custom). Games were played for 8.5 minutes with ten minutes of rest in between so they could return to physiological baseline. During exercise they reported exertion and at the end of teach exercise trial they completed an enjoyment questionnaire. At the end of the first block, participants removed the metabolic system's mask and were assessed for motor recovery. Performances were video taped. At the end of data collection preferences for the activities were ranked and participants answered open ended questions. Data for neuromuscular and cardiovascular intensity, enjoyment and perceived effort were reduced and analyzed using a Repeated Measures Analysis of Variance (RMANOVA) with the appropriate post-hoc corrections. Where possible clinically meaningful changes were calculated.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Repeated measures, counter-balancedRepeated measures, counter-balanced
Masking:
None (Open Label)
Masking Description:
Participants were told that the purpose of the study was to learn more about what type of exercise they liked. There was no indication that intensity was an outcome measure.
Primary Purpose:
Other
Official Title:
Exercise Intensity During Interactive Video Games and Standard of Care of Individuals Post-Stroke
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Aug 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Single

Participants exercised in two counter balanced blocks: repeated (standard of care and self-paced repeated custom game) and random (Kinect game and game-paced random custom game). Exercise bouts were for 8.5 minutes with ten minutes of rest in between so they could return to physiological baseline. Data were collected in a single session lasting two hours.

Behavioral: Exercise
Participants performed stepping movements that were either cued by the investigator or interacted with a video game. There were three video game exercises that all involved stepping in either a repeated or a random pattern that was either self-paced or game paced.
Other Names:
  • Video Game Play
  • Standard of Care Stepping Activities

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neuromuscular intensity [collected continuously during each of the four conditions. Collected in a single 2 hour session]

      movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout

    2. Cardiovascular intensity (metabolic Units) [collected continuously during each of the four conditions. Collected in a single 2 hour session]

      metabolic units measured continuously during each exercise bout

    3. Cardiovascular intensity (Percent of maximum heart rate) [collected continuously during each of the four conditions. Collected in a single 2 hour session]

      the percent of the maximum heart rate

    4. Enjoyment [four times collected in a single 2 hour session (once at the completion of each the four conditions).]

      measured with the PACES questionnaire after each exercise bout

    5. Borg Rate if Perceived Exertion Scale [Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session]

      Measures perception of effort on a scale of 6-20

    Secondary Outcome Measures

    1. Preference ranking [collected once at the end of the completed data collection of a 2 hour session]

      ranking exercise preference from highest (1) to lowest (4)

    2. Fugl Meyer Motor Assessment Scale_ Lower Extremity Section [collected once during the single 2 hour data collection session]

      measure of lower extremity motor recovery

    Other Outcome Measures

    1. Open ended questions [collected once during a single 2 hour data collection session]

      questions about preference and exertion and anything else the participants wants to share

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • men and women post-stroke at least six months T

    • able to ambulate 100 feet without physical assistance but allowed to use assistive devices and orthotics,

    • able to stand for 3 minutes.

    • cleared for exercise with the PARQ.

    Exclusion Criteria:

    1. history of severe heart disease, heart attack, valve replacement or coronary artery bypass surgery, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than stroke

    2. Are unable to follow directions.

    3. Do not have adequate vision and hearing ability (either aided or unaided with glasses, contacts or hearing aids

    4. Are unable to sign a consent form.

    5. Unstable medical condition or musculoskeletal disorder such as severe arthritis, knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to perform the required stepping for the games presented.

    6. Any other medical condition contraindications to exercise.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Health Professions Newark New Jersey United States 07011

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey

    Investigators

    • Principal Investigator: Judith Deutsch, PT, PhD, Rutgers University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Judith E Deutsch, PT, PhD, Professor and Director Rivers Lab, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT04538326
    Other Study ID Numbers:
    • Pro20160000916
    First Posted:
    Sep 4, 2020
    Last Update Posted:
    Sep 4, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Judith E Deutsch, PT, PhD, Professor and Director Rivers Lab, Rutgers, The State University of New Jersey
    active video games
    virtual reality
    exercise intensity
    Parkinson Disease
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Sep 4, 2020