Aerobic Exercise in Patients With Stroke

NCT05429255 | Completed

• 1 other identifier: AAAU0558
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Exercise; Aerobic; Exergame

Outcome Measures

Primary Outcomes (1)

• Average Gait Speed

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

  baseline and 1 month

Secondary Outcomes (4)

• VO2max

  baseline and 1 month

• Timed up and GO

  baseline and 1 month

• Berg Balance Scale

  baseline and 1 month

• Cognition

  baseline and 1 month

Study Arms (2)

Aerobic Training

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Exergame Training

ACTIVE COMPARATOR

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.

Behavioral: Exergame Training

Interventions

Aerobic Exercise BEHAVIORAL

Bicycle training

Aerobic Training

Exergame Training BEHAVIORAL

Nintendo Wii

Exergame Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Scott A. Barbuto, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Person performing outcome assessments will not know which group the patient is assigned. Participant cannot be blinded given nature of intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel groups.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 23, 2022
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)