Clinical trial NCT04564495: Home Based Tele-exercise for People With Chronic Neurological Impairments
Official title: Home Based Tele-exercise for People With Chronic Neurological Impairments
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neurologic Disorder
Stroke
Spinal Cord Injuries
Cerebral Palsy
Hemiplegia
Hemiparesis
Multiple Sclerosis
Parkinson Disease
Trauma, Brain
Transverse Myelitis
Friedreich Ataxia
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will attend live zoom classes with instructor feedback, and the other group will exercise using pre-recorded sessions.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in heart rate
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
Secondary outcomes:
measure: Perceived Wellness Survey
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Physical Activity Enjoyment Scale
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Short Form-36 Health Survey
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Numerical pain rating
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Borg's Rating Scale of Perceived Exertion
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
measure: Reason for exercise inventory
timeFrame: Within one week before the first intervention session to within one week after the end of intervention
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Neurological Institute
state: New York
Study officials:
affiliation: Burke Medical Research Institute
name: Kathleen Friel
role: PRINCIPAL_INVESTIGATOR
References: