Home Based Tele-exercise for People With Chronic Neurological Impairments

Stroke Clinical Trial

— Telex  

Official title:

Home Based Tele-exercise for People With Chronic Neurological Impairments

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04564495
• Other study ID #: Telex
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Burke Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Cerebral Palsy
• Friedreich Ataxia
• Hemiparesis
• Hemiplegia
• Multiple Sclerosis
• Myelitis
• Myelitis, Transverse
• Nervous System Diseases
• Neurologic Disorder
• Paresis
• Parkinson Disease
• Spinal Cord Injuries
• Stroke
• Transverse Myelitis
• Trauma, Brain

Intervention

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.

Locations

Country	Name	City	State
United States	Burke Neurological Institute	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Burke Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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