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

Primary Purpose

Neurologic Disorder, Stroke, Spinal Cord Injuries

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seated exercise
Sponsored by
Burke Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurologic Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Burke Neurological Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Live zoom exercise classes

Recorded zoom exercise classes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in heart rate
Heart rate on last day of training compared to heart rate on first day of training

Secondary Outcome Measures

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
Physical Activity Enjoyment Scale
a self-assessment measure of enjoyment with their current physical activity
Short Form-36 Health Survey
measures physical health and mental health
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
Borg's Rating Scale of Perceived Exertion
standardized measure to evaluate perceived intensity of exertion, effort, and fatigue during physical exercise
Reason for exercise inventory
is a 24-item scale to assess the reason that motivates a person to exercise

Full Information

First Posted
September 23, 2020
Last Updated
January 29, 2023
Sponsor
Burke Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04564495
Brief Title
Home Based Tele-exercise for People With Chronic Neurological Impairments
Acronym
Telex
Official Title
Home Based Tele-exercise for People With Chronic Neurological Impairments
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burke Medical Research Institute

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Disorder, Stroke, Spinal Cord Injuries, Cerebral Palsy, Hemiplegia, Hemiparesis, Multiple Sclerosis, Parkinson Disease, Trauma, Brain, Transverse Myelitis, Friedreich Ataxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will attend live zoom classes with instructor feedback, and the other group will exercise using pre-recorded sessions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Live zoom exercise classes
Arm Type
Experimental
Arm Description
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.
Arm Title
Recorded zoom exercise classes
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Seated exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in heart rate
Description
Heart rate on last day of training compared to heart rate on first day of training
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Secondary Outcome Measure Information:
Title
Perceived Wellness Survey
Description
a 36-item instrument used to measure an individual's perceived health status in physical, psychological, emotional, intellectual, spiritual, and social wellness constructs
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Physical Activity Enjoyment Scale
Description
a self-assessment measure of enjoyment with their current physical activity
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Short Form-36 Health Survey
Description
measures physical health and mental health
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Numerical pain rating
Description
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
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Borg's Rating Scale of Perceived Exertion
Description
standardized measure to evaluate perceived intensity of exertion, effort, and fatigue during physical exercise
Time Frame
Within one week before the first intervention session to within one week after the end of intervention
Title
Reason for exercise inventory
Description
is a 24-item scale to assess the reason that motivates a person to exercise
Time Frame
Within one week before the first intervention session to within one week after the end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with chronic (>6 months) neurological impairments 18 to 75 years of age Participants who can provide a medical clearance to participate in the program Participants who can remain seated for at least one hour Heart rate/BP considerations, per each participant's MD Participants must be able to don/doff HR monitor without assistance, or have assistance if necessary Participants must maintain their current exercise/physical activity routine during the course of the study Clinically stable with no other neurological, medical or cognitive impairments Reliable Internet connection and ability to use Zoom platform Participants must speak and understand English No contraindication/limitations to exercise Currently exercising 2 days or less per week Exclusion Criteria: Participants with any cognitive impairment preventing safe and accurate participation in the program Medical issues preventing safe participation Other problems possibly contraindicating autonomous exercise at home if no supervision available.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Friel
Organizational Affiliation
Burke Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Neurological Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Home Based Tele-exercise for People With Chronic Neurological Impairments

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