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

Sponsor

Burke Medical Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04564495

Collaborator

(none)

Enrollment

Location

Arms

35.3

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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).

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.

Study Design

Study Type:

Interventional

Anticipated 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.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

Actual Study Start Date :

Jan 22, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Change in heart rate [week 12]
Heart rate on last day of training compared to heart rate on first day of training

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.