NCT04564495

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

September 23, 2020

Last Update Submit

February 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Perceived Wellness Survey

    Within one week before the first intervention session to within one week after the end of intervention

  • Physical Activity Enjoyment Scale

    Within one week before the first intervention session to within one week after the end of intervention

  • Short Form-36 Health Survey

    Within one week before the first intervention session to within one week after the end of intervention

  • Numerical pain rating

    Within one week before the first intervention session to within one week after the end of intervention

  • Borg's Rating Scale of Perceived Exertion

    Within one week before the first intervention session to within one week after the end of intervention

  • +1 more secondary outcomes

Study Arms (2)

Live zoom exercise classes

EXPERIMENTAL

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

Recorded zoom exercise classes

ACTIVE COMPARATOR

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

Interventions

Seated exerciseBEHAVIORAL

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.

Live zoom exercise classesRecorded zoom exercise classes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with chronic (\>6 months) neurological impairments
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burke Neurological Institute

White Plains, New York, 10605, United States

Location

Related Publications (2)

  • Kumar DS, Bialek A, Divecha AA, Garn RM, Currie LEJ, Friel KM. A seated virtual exercise program to improve cardiovascular function in adults with chronic neurological impairments: a randomized controlled trial. Front Rehabil Sci. 2025 Mar 26;6:1477969. doi: 10.3389/fresc.2025.1477969. eCollection 2025.

  • Divecha AA, Bialek A, Kumar DS, Garn RM, Currie LEJ, Campos T, Friel KM. Effects of a 12-week, seated, virtual, home-based tele-exercise programme compared with a prerecorded video-based exercise programme in people with chronic neurological impairments: protocol for a randomised controlled trial. BMJ Open. 2023 Jan 24;13(1):e065032. doi: 10.1136/bmjopen-2022-065032.

MeSH Terms

Conditions

Nervous System DiseasesStrokeSpinal Cord InjuriesCerebral PalsyHemiplegiaParesisMultiple SclerosisParkinson DiseaseBrain Injuries, TraumaticMyelitis, TransverseFriedreich Ataxia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and InjuriesBrain Damage, ChronicParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBrain InjuriesCraniocerebral TraumaMyelitisCentral Nervous System InfectionsInfectionsParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesNeuroinflammatory DiseasesSpinocerebellar DegenerationsCerebellar DiseasesHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMitochondrial DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kathleen Friel

    Burke Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group will attend live zoom classes with instructor feedback, and the other group will exercise using pre-recorded sessions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 25, 2020

Study Start

January 22, 2021

Primary Completion

December 31, 2023

Study Completion

May 31, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

We plan to use the concept, methods and analysis as a framework to develop evidence-based protocols for future cohorts and studies. We have made a commitment to publish all relevant scientific information in a timely manner. Unpublished information may be available to interested individuals or organizations by request to the Principal Investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
These types of supporting information will be published as a protocol paper, and will remain accessible with no end date.

Locations