Home Based Tele-exercise for People With Chronic Neurological Impairments

Not Applicable

Active, not recruiting

• Conditions: Hemiparesis; Parkinson Disease; Transverse Myelitis; Trauma, Brain; Stroke; Cerebral Palsy; Friedreich Ataxia; Neurologic Disorder; Spinal Cord Injuries; Hemiplegia

• Registration Number: NCT04564495
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-25
• Study Start: 2021-01-22
• Primary Completion: 2023-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Physical Activity Enjoyment Scale	Within one week before the first intervention session to within one week after the end of intervention	a self-assessment measure of enjoyment with their current physical activity
Numerical pain rating	Within one week before the first intervention session to within one week after the end of intervention	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
Perceived Wellness Survey	Within one week before the first intervention session to within one week after the end of intervention	a 36-item instrument used to measure an individual's perceived health status in physical, psychological, emotional, intellectual, spiritual, and social wellness constructs
Short Form-36 Health Survey	Within one week before the first intervention session to within one week after the end of intervention	measures physical health and mental health
Reason for exercise inventory	Within one week before the first intervention session to within one week after the end of intervention	is a 24-item scale to assess the reason that motivates a person to exercise
Borg's Rating Scale of Perceived Exertion	Within one week before the first intervention session to within one week after the end of intervention	standardized measure to evaluate perceived intensity of exertion, effort, and fatigue during physical exercise

Trial Locations

Locations (1)

Burke Neurological Institute; 🇺🇸 White Plains, New York, United States