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Aerobic Exercise in Patients With Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Exergame Training
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Aerobic, Exergame

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stroke greater than 3 months ago
  • NIH stroke scale score less than 15

Exclusion Criteria:

  • Other neurological impairments
  • Medically unstable
  • Inability to exercise
  • Joint pain
  • Heart failure or other heart arrythmias

Sites / Locations

  • Columbia University Irving Medical Center / NewYork-Presbyterian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Training

Exergame Training

Arm Description

Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's maximum heart rate based on age. The exercise program will start at 60% of max heart rate, and then will be increased by steps of 5% intensity every 2 weeks until participants reach 30 minutes of training at 80% intensity. In addition, rate of perceived exertion (Borg scale) will be assessed at each training session. Participants will be contacted weekly by email or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance. Subjects will be asked to use the bike for 1 month

The Nintendo wii system will be used as the rehabilitation exergame system in the study. Wii-fit games will be used and the subjects will be shown to system at the initial assessment. Participants will be instructed to play 30 minutes a day, 5 days per week for 1 month. Participants will be contacted weekly by email or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, balance challenge, and which games they played.

Outcomes

Primary Outcome Measures

Average Gait Speed
Participants will walk as fast as possible on a 9-m runway 3 times, and the results will be averaged.

Secondary Outcome Measures

VO2max
Maximal oxygen consumption (VO2max) will be determined by a breath by-breath measurement of VO2 with a Vmax Encore Metabolic System (CareFusion Corp, San Diego, CA), while participants perform a progressive ramped exercise test using an electronic-braked lower body cycle ergometer.
Timed up and GO
Participants will be asked to stand up from a seated position, walk 10 feet at a normal pace, then return to the chair and sit down. The examiner will time the procedure.
Berg Balance Scale
Participants will complete the 14 part Berg Balance test which requires them to complete basic functional movements that are each evaluated on a 4-point scale.
Cognition
Cognition will be assessed using a standardized, computerized test that is a part of the NIH Toolbox for Assessment of Neurological and Behavioral Function. It assesses various cognitive domains through simple, validated cognitive tasks.

Full Information

First Posted
June 17, 2022
Last Updated
November 4, 2022
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05429255
Brief Title
Aerobic Exercise in Patients With Stroke
Official Title
Aerobic Training vs Exergame Training in Patients With Chronic Mild-Moderate Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

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 purpose of this study is to compare aerobic training to exergame training in people with chronic mild/moderate stroke. The objectives of this study are two-fold: 1) To evaluate the effects of a home-based aerobic exercise cycle ergometer program on cardiorespiratory fitness, mobility, cognitive, and exercise self-efficacy outcomes in subacute and chronic stroke patients; and 2) to evaluate the effects of an exergaming program on the same outcomes.
Detailed Description
Annually, 13.7 million strokes occur worldwide, placing it as a leading cause of death and disability, especially among older adults. Stroke survivors often face significant cognitive and motor impairments for months to years after a stroke event, creating significant deficits in functional capacity during activities of daily living (ADLs), as well as in overall quality of life. Stroke patients have identified interventions to improve cognitive outcomes, mobility training, and exercise programs as top priorities for guiding research pursuits. Aerobic exercise has been shown to produce significant improvements in key stroke rehabilitation outcomes, including functional movement, balance and cardiorespiratory fitness. Exercise programs have been shown to improve a variety of functional outcomes important for carrying out ADLs, including gait speed, gait endurance, Berg Balance Score, and 3-meter Timed Up and Go. Additionally, there is mounting evidence that aerobic exercise may improve cognitive recovery post-stroke. However, the research showing these effects has largely focused on exercise programs incorporated in a hospital or rehabilitation facility where patients are actively supervised by rehabilitation specialists. The American Heart Association recognizes that long-term and widely-applicable solutions for increasing exercise in post-stroke populations must hold the goal of exercise independence in the home and community settings. Cycle ergometry, commonly known as an exercise bike, is a staple for stroke rehabilitation programs given its minimal fall risk and ability to produce moderate to vigorous intensity physical activity in participants. Exercise programs using cycle ergometry have been shown to produce all previously mentioned functional and cardiorespiratory improvements in stroke survivors, however, the translation of this effectiveness to the home-environment is unknown. Additionally, cycle ergometry may have smaller effects on functional mobility outcomes than walking interventions, forcing prescribing physicians and patients to choose between long-term improvement and reduced fall risk. One potential alternative or supplement to traditional aerobic exercise programs is exergaming, interventions which use physically active video games to engage participants in exercise. Exergames have been shown to be safe and produce moderate intensity physical activity levels in subacute and chronic stroke patients. Additionally, they have been shown to increase a variety of functional outcomes when added to standard post-stroke rehabilitation care, however, like aerobic exercise programs, previous research has focused on the supervised clinical setting, and it is unknown if they produce similar effects to aerobic exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Exercise, Aerobic, Exergame

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel groups.
Masking
Outcomes Assessor
Masking Description
Person performing outcome assessments will not know which group the patient is assigned. Participant cannot be blinded given nature of intervention.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Training
Arm Type
Experimental
Arm Description
Participants will be given a stationary exercise bike for home use. They will be instructed to use the exercise bike five times a week for thirty-minute sessions. The exercise intensity prescription will be based on the subject's maximum heart rate based on age. The exercise program will start at 60% of max heart rate, and then will be increased by steps of 5% intensity every 2 weeks until participants reach 30 minutes of training at 80% intensity. In addition, rate of perceived exertion (Borg scale) will be assessed at each training session. Participants will be contacted weekly by email or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, average heart rate, maximum heart rate, and distance. Subjects will be asked to use the bike for 1 month
Arm Title
Exergame Training
Arm Type
Active Comparator
Arm Description
The Nintendo wii system will be used as the rehabilitation exergame system in the study. Wii-fit games will be used and the subjects will be shown to system at the initial assessment. Participants will be instructed to play 30 minutes a day, 5 days per week for 1 month. Participants will be contacted weekly by email or phone to answer any questions about the exercise protocol and will be instructed to log each training session. Subjects will record duration of exercise, perceived exertion, balance challenge, and which games they played.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Bicycle training
Intervention Type
Behavioral
Intervention Name(s)
Exergame Training
Intervention Description
Nintendo Wii
Primary Outcome Measure Information:
Title
Average Gait Speed
Description
Participants will walk as fast as possible on a 9-m runway 3 times, and the results will be averaged.
Time Frame
baseline and 1 month
Secondary Outcome Measure Information:
Title
VO2max
Description
Maximal oxygen consumption (VO2max) will be determined by a breath by-breath measurement of VO2 with a Vmax Encore Metabolic System (CareFusion Corp, San Diego, CA), while participants perform a progressive ramped exercise test using an electronic-braked lower body cycle ergometer.
Time Frame
baseline and 1 month
Title
Timed up and GO
Description
Participants will be asked to stand up from a seated position, walk 10 feet at a normal pace, then return to the chair and sit down. The examiner will time the procedure.
Time Frame
baseline and 1 month
Title
Berg Balance Scale
Description
Participants will complete the 14 part Berg Balance test which requires them to complete basic functional movements that are each evaluated on a 4-point scale.
Time Frame
baseline and 1 month
Title
Cognition
Description
Cognition will be assessed using a standardized, computerized test that is a part of the NIH Toolbox for Assessment of Neurological and Behavioral Function. It assesses various cognitive domains through simple, validated cognitive tasks.
Time Frame
baseline and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke greater than 3 months ago NIH stroke scale score less than 15 Exclusion Criteria: Other neurological impairments Medically unstable Inability to exercise Joint pain Heart failure or other heart arrythmias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Schibler
Phone
212-305-3535
Email
bms2222@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A. Barbuto, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott A. Barbuto, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Aerobic Exercise in Patients With Stroke

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