Exercise Intensity and Video Games: Persons Post-stroke

Stroke Clinical Trial

Official title:

Exercise Intensity During Interactive Video Games and Standard of Care of Individuals Post-Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538326
• Other study ID #: Pro20160000916
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: August 2020
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	School of Health Professions	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kafri M, Myslinski MJ, Gade VK, Deutsch JE. Energy expenditure and exercise intensity of interactive video gaming in individuals poststroke. Neurorehabil Neural Repair. 2014 Jan;28(1):56-65. doi: 10.1177/1545968313497100. Epub 2013 Jul 29. — View Citation

Kafri M, Myslinski MJ, Gade VK, Deutsch JE. High metabolic cost and low energy expenditure for typical motor activities among individuals in the chronic phase after stroke. J Neurol Phys Ther. 2014 Oct;38(4):226-32. doi: 10.1097/NPT.0000000000000053. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Open ended questions	questions about preference and exertion and anything else the participants wants to share	collected once during a single 2 hour data collection session
Primary	Neuromuscular intensity	movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout	collected continuously during each of the four conditions. Collected in a single 2 hour session
Primary	Cardiovascular intensity (metabolic Units)	metabolic units measured continuously during each exercise bout	collected continuously during each of the four conditions. Collected in a single 2 hour session
Primary	Cardiovascular intensity (Percent of maximum heart rate)	the percent of the maximum heart rate	collected continuously during each of the four conditions. Collected in a single 2 hour session
Primary	Enjoyment	measured with the PACES questionnaire after each exercise bout	four times collected in a single 2 hour session (once at the completion of each the four conditions).
Primary	Borg Rate if Perceived Exertion Scale	Measures perception of effort on a scale of 6-20	Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session
Secondary	Preference ranking	ranking exercise preference from highest (1) to lowest (4)	collected once at the end of the completed data collection of a 2 hour session
Secondary	Fugl Meyer Motor Assessment Scale_ Lower Extremity Section	measure of lower extremity motor recovery	collected once during the single 2 hour data collection session