Home Based Tele-exercise for People With Chronic Neurological Impairments (Telex)

To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Multiple Sclerosis; Cerebral Palsy; Parkinson Disease; Spinal Cord Injuries; Neurologic Disorder; Hemiplegia; Hemiparesis; Friedreich Ataxia; Trauma, Brain; Transverse Myelitis
• Intervention / Treatment: Behavioral: Seated exercise

Detailed Description

This study aims to examine how effective seated Zoom exercise classes are for a person with CNI for addressing cardiovascular health, physical wellness and quality of life. If these classes prove to be effective, online platforms could be a viable avenue for those with CNI to exercise and increase/maintain wellness without having to leave their homes. The investigators are also attempting to determine if a class with a live instructor vs a pre-recorded class has an effect on motivation, compliance, exertion and modifications/safety.

The entire process, including screening and consenting, will be done via Zoom and Redcap, potentially providing a blueprint for the future studies. This process can enable participants to participate in studies with minimal inconvenience, expense and effort of traveling for the consent process.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Burke Neurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants with chronic (>6 months) neurological impairments
2. 18 to 75 years of age
3. Participants who can provide a medical clearance to participate in the program
4. Participants who can remain seated for at least one hour
5. Heart rate/BP considerations, per each participant's MD
6. Participants must be able to don/doff HR monitor without assistance, or have assistance if necessary
7. Participants must maintain their current exercise/physical activity routine during the course of the study
8. Clinically stable with no other neurological, medical or cognitive impairments
9. Reliable Internet connection and ability to use Zoom platform
10. Participants must speak and understand English
11. No contraindication/limitations to exercise
12. Currently exercising 2 days or less per week

Exclusion Criteria:

1. Participants with any cognitive impairment preventing safe and accurate participation in the program
2. Medical issues preventing safe participation
3. Other problems possibly contraindicating autonomous exercise at home if no supervision available.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live zoom exercise classes; Participants will engage in a live zoom exercise session. Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.	Behavioral: Seated exercise; Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.
Active Comparator: Recorded zoom exercise classes; Participants will undergo 45 minutes of aerobic exercise intervention, three times a week, for a period of 12 weeks, using a pre-recorded class that they can do according to their own schedule. Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.	Behavioral: Seated exercise; Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Heart rate on last day of training compared to heart rate on first day of training	Within one week before the first intervention session to within one week after the end of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Wellness Survey	a 36-item instrument used to measure an individual's perceived health status in physical, psychological, emotional, intellectual, spiritual, and social wellness constructs	Within one week before the first intervention session to within one week after the end of intervention
Physical Activity Enjoyment Scale	a self-assessment measure of enjoyment with their current physical activity	Within one week before the first intervention session to within one week after the end of intervention
Short Form-36 Health Survey	measures physical health and mental health	Within one week before the first intervention session to within one week after the end of intervention
Numerical pain rating	standardized instrument for pain assessment in clinical and research practice. It is an 11-point scale from 0 (no pain) to 10 (the most intense pain) at rest and during movement	Within one week before the first intervention session to within one week after the end of intervention
Borg's Rating Scale of Perceived Exertion	standardized measure to evaluate perceived intensity of exertion, effort, and fatigue during physical exercise	Within one week before the first intervention session to within one week after the end of intervention
Reason for exercise inventory	is a 24-item scale to assess the reason that motivates a person to exercise	Within one week before the first intervention session to within one week after the end of intervention

Collaborators and Investigators

• Sponsor: Burke Medical Research Institute
• Investigators: Principal Investigator: Kathleen Friel, Burke Medical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Neuroinflammatory Diseases; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Movement Disorders; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Heredodegenerative Disorders, Nervous System; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Parkinsonian Disorders; Basal Ganglia Diseases; Spinal Cord Diseases; Central Nervous System Infections; Brain Injuries; Paralysis; Mitochondrial Diseases; Cerebellar Diseases; Spinocerebellar Degenerations; Brain Injuries, Traumatic; Multiple Sclerosis; Cerebral Palsy; Parkinson Disease; Paresis; Spinal Cord Injuries; Nervous System Diseases; Friedreich Ataxia; Hemiplegia; Myelitis; Myelitis, Transverse
• Other Study ID Numbers: Telex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to use the concept, methods and analysis as a framework to develop evidence-based protocols for future cohorts and studies. We have made a commitment to publish all relevant scientific information in a timely manner. Unpublished information may be available to interested individuals or organizations by request to the Principal Investigator.
• IPD Sharing Time Frame: These types of supporting information will be published as a protocol paper, and will remain accessible with no end date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No