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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564495
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Burke Medical Research Institute

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).

Condition or disease Intervention/treatment Phase
Neurologic Disorder Stroke Spinal Cord Injuries Cerebral Palsy Hemiplegia Hemiparesis Multiple Sclerosis Parkinson Disease Trauma, Brain Transverse Myelitis Friedreich Ataxia Behavioral: Seated exercise Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Home Based Tele-exercise for People With Chronic Neurological Impairments
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023


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.




Primary Outcome Measures :
  1. Change in heart rate [ Time Frame: week 12 ]
    Heart rate on last day of training compared to heart rate on first day of training



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564495


Contacts
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Contact: Kathleen Friel 6463519063 kaf3001@med.cornell.edu

Locations
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United States, New York
Burke Neurological Institute Recruiting
White Plains, New York, United States, 10605
Contact: Kathleen Friel, PhD    914-368-3116    kaf3001@med.cornell.edu   
Principal Investigator: Kathleen Friel, PhD         
Sponsors and Collaborators
Burke Medical Research Institute
Investigators
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Principal Investigator: Kathleen Friel Burke Medical Research Institute
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Responsible Party: Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT04564495    
Other Study ID Numbers: Telex
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myelitis, Transverse
Parkinson Disease
Multiple Sclerosis
Spinal Cord Injuries
Cerebral Palsy
Hemiplegia
Paresis
Friedreich Ataxia
Myelitis
Nervous System Diseases
Brain Injuries, Traumatic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Neurologic Manifestations
Paralysis
Spinocerebellar Degenerations
Cerebellar Diseases