Neurologic DisorderTelexNCT04564495
Home Based Tele-exercise for People With Chronic Neurological Impairments
A study testing Seated exercise in people with Neurologic Disorder and Stroke, run by Burke Medical Research Institute at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurologic Disorder, Stroke, Spinal Cord Injuries
- What is being tested?
- Seated exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Neurological Institute
White Plains, New York, 10605
About this study
To assess the impact of a 12-week virtual seated physical intervention on cardiovascular health and wellness in people with chronic neurological impairments (CNI).
Read the 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.
- Conditions
- Neurologic Disorder, Stroke, Spinal Cord Injuries, Cerebral Palsy, Hemiplegia, Hemiparesis
- Being tested
- Seated exercise
- Medical subject headings
- Nervous System Diseases, Stroke, Spinal Cord Injuries, Cerebral Palsy, Hemiplegia, Paresis, Multiple Sclerosis, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Seated exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
Heart rate on last day of training compared to heart rate on first day of training
Measured: Within one week before the first intervention session to within one week after the end of intervention
Secondary outcomes (6)
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
Measured: Within one week before the first intervention session to within one week after the end of intervention
Physical Activity Enjoyment Scale
a self-assessment measure of enjoyment with their current physical activity
Measured: Within one week before the first intervention session to within one week after the end of intervention
Short Form-36 Health Survey
measures physical health and mental health
Measured: Within one week before the first intervention session to within one week after the end of intervention
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
Measured: Within one week before the first intervention session to within one week after the end of intervention
Borg's Rating Scale of Perceived Exertion
standardized measure to evaluate perceived intensity of exertion, effort, and fatigue during physical exercise
Measured: Within one week before the first intervention session to within one week after the end of intervention
Reason for exercise inventory
is a 24-item scale to assess the reason that motivates a person to exercise
Measured: Within one week before the first intervention session to within one week after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start22 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will attend live zoom classes with instructor feedback, and the other group will exercise using pre-recorded sessions.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Friel, Principal investigator, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564495
- Sponsor's protocol ID
- Telex
- Acronym
- Telex
- Status last verified
- Feb 2025
- First submitted
- 23 Sep 2020
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40207026Divecha 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.
PubMed 36693691
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Tele-exercise for People With Chronic Neurological Impairments
- ClinicalTrials.gov ID
- NCT04564495
- Acronym / sponsor ID
- Telex / Telex
- Conditions
- Neurologic Disorder, Stroke, Spinal Cord Injuries, Cerebral Palsy, Hemiplegia, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will attend live zoom classes with instructor feedback, and the other group will exercise using pre-recorded sessions.
| Arm | Type | Receives |
|---|---|---|
| Live zoom exercise classes | Experimental | Behavioral: Seated exerciseParticipants 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. |
| Recorded zoom exercise classes | Active comparator | Behavioral: Seated exerciseParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seated exerciseExercise 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. | Behavioural | Live zoom exercise classes, Recorded zoom exercise classes |
Primary outcome
Change in heart rate
Time frame: 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
6 secondary outcomes
Perceived Wellness Survey
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Physical Activity Enjoyment Scale
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Short Form-36 Health Survey
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Numerical pain rating
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Borg's Rating Scale of Perceived Exertion
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Reason for exercise inventory
Time frame: Within one week before the first intervention session to within one week after the end of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 40207026Kumar 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.
- Derived from this study: PubMed 36693691Divecha 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Friel principal investigator
Burke Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seated exercise in people with Neurologic Disorder and Stroke, run by Burke Medical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate (time frame: Within one week before the first intervention session to within one week after the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564495, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.