StrokeCAPSNCT05919251
Influence of Cognition on Activity and Participation in People With Stroke
A study testing Ageless Grace in people with Stroke and Cognitive Change, run by Saint Joseph's University, Philadelphia at 1 site in United States.
Trial summary
If a subject agrees to participate, the primary investigators will collect some basic information including age, height, and weight. Intake of some general questions regarding health will be performed and each subject will complete some tests that measure walking speed, cognition, and balance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cognitive Change, Neurological Injury
- What is being tested?
- Ageless Grace
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- 1 or more strokes at least 3 months ago
- Able to follow directions and talk with the researchers
- Able to safely exercise in a group setting when sitting as determined by your primary healthcare provider
- Retired or semi-retired
- Be able to walk without assistance
- Able to safely exercise in a group setting when sitting as determined by your primary healthcare provider
Who cannot join
- Bone or joint problems that restrict your movement or walking
- Really high or low blood pressure or pulse
- Pain in your chest or difficulty breathing when you are sitting
- Any other neurological problems
- Lack of clearance provided to you by your primary health care provider
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Saint Joseph's University
Philadelphia, Pennsylvania, 19104
gregory thielman, EdD, 856-266-7863, g.thielm@usciences.edu
Margaret Roos, PhD, 2155968676, mroos@sju.edu
About this study
Official title: A Telehealth Exercise Program to Improve Cognition in People With Stroke
If a subject agrees to participate, the primary investigators will collect some basic information including age, height, and weight. Intake of some general questions regarding health will be performed and each subject will complete some tests that measure walking speed, cognition, and balance. During these tests participants will be asked to stand from a chair, walk up \& down a staircase, walk over objects in a forward, backward, and sideways directions, walk around objects in forward and backward directions. After completing those tests, participants will be asked to repeat them while doing another task such as counting out loud, naming objects, or passing an object from one hand to another.
Read the detailed description
After stroke, it has been noted that up to 70% of people have cognitive impairment , between 20-60% experience depression and most are significantly less active than healthy older adults. These deficits are particularly problematic as they affect quality of life, participation in community activities and lead to a cycle of declining function. In people post stroke, participation in exercise programs has been associated with improvements in cognitive function, but others have found no cognitive improvements. Other exercise programs have helped people with stroke with depression, decreased falls incidence, and improved walking activity, but other research shows a lack of carryover of exercise programs to participation in the community. Of note, some standard outcome measures used in this work are not sensitive to change and some disadvantage those with aphasia, while many have been almost exclusively paper and pencil tests. This research project will be using a battery of cognitive measures to capture change in participants.
The investigators will assess the person's ability to change their cognitive status by using functional tests with and without a cognitive challenge and compare changes with those seen in computerized testing as that represents the gold standard. This unique program attempts to combine multiple aspects that easily fit together including music and a group setting for socialization. The use of music to improve cognition as has been shown in other research studies to improve participation in exercise program. By linking cognitive retraining, low intensity exercise, group activities and music, the researchers of this project can determine if a movement program with these attributes can benefit individuals as a program of wellness, once their rehabilitation plans have been completed. The researchers are specifically interested in the effect on balance, activity and incidence of falls in people with chronic stroke. Additionally, the researchers will investigate the differences that this structured program will make on older adults who will act as a comparison group. This will bring insight into some of the additional challenges that people with stroke encounter on a daily basis.
- Being tested
- Ageless Grace
- Keywords
- stroke, cognition, dual task, exercise
- Medical subject headings
- Stroke, Trauma, Nervous System, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ageless GraceBehavioural
This unique program attempts to combine multiple aspects that easily fit together including music and a group setting for socialization. The use of music to improve cognition as has been shown in other research studies to improve participation in exercise program. By linking cognitive retraining, low intensity exercise, group activities and music, the researchers of this project can determine if a movement program with these attributes can benefit individuals as a program of wellness once their rehabilitation plans have been completed. The researchers are specifically interested in the effect on balance, activity and incidence of falls in people with chronic stroke. Additionally, the researchers will investigate the differences that this structured program will make on older adults who will act as a comparison group. This will bring insight into some of the additional challenges that people with stroke encounter on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Older Adults | Active comparator | This subset of subject's have a fair history with this methodology and are being used as the comparator. Age matched older adults Receives: Behavioral: Ageless Grace |
| Subject's Post Stroke | Experimental | Individuals post stroke have recently participated in this ongoing investigation in a live format but these subjects are now entered into a telehealth arm. In the future others will participate in the live format Receives: Behavioral: Ageless Grace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in cognitive and motor function in individuals post stroke compared to age matched older adults measured by time differential between various walking distances and these tasks with a cognitive activity challenge included.
The primary purpose is to determine the impact of a low intensity seated exercise program (24 sessions 2x/wk for 12 weeks) with cognitive training on dual task function
Measured: effects as a result of 24 sessions, approximately 12 weeks after the start of the program
Differences in cognitive and motor function in individuals post stroke compared to age matched older adults will be measured by time differential between isolated motor tasks (number of sit to stands) and task with cognitive activity challenge.
The primary purpose is to determine the impact of a low intensity seated exercise program (24 sessions 2x/wk for 12 weeks) with cognitive training on dual task function
Measured: effects as a result of 24 sessions, approximately 12 weeks after the start of the program
Differences in cognitive and motor function measured by time differential between isolated motor tasks (number of seated alternative limb marches) and tasks that include a cognitive activity challenge as well.
The primary purpose is to determine the impact of a low intensity seated exercise program (24 sessions 2x/wk for 12 weeks) with cognitive training on dual task function
Measured: effects as a result of 24 sessions, approximately 12 weeks after the start of the program
Secondary outcomes (1)
Walking monitors measurement
The secondary objectives are to determine the effects of the exercise program on walking activity (steps per day) for all enrolled subjects, while at home \& in the community; as a result of the 24 training sessions
Measured: effects of a 3 day baseline walking average (prior to the 24 sessions at 2x/wk) compared to a 3 day walking average post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jun 2020
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pretest posttest 2 groups x 2 test sessions
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Joseph's University, Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- greg thielman, EdD, Principal investigator, Saint Joseph's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919251
- Sponsor's protocol ID
- 1301299
- Acronym
- CAPS
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: other researchers in the group are investigating other aspects and will need access
Publications
Cumming TB, Bernhardt J, Lowe D, Collier J, Dewey H, Langhorne P, Thrift AG, Green A, Mohanraj R, Kramer SF, Churilov L, Linden T; AVERT Trial Collaboration group. Early Mobilization After Stroke Is Not Associated With Cognitive Outcome. Stroke. 2018 Sep;49(9):2147-2154. doi: 10.1161/STROKEAHA.118.022217.
PubMed 30354969Gaynor E, Rohde D, Large M, Mellon L, Hall P, Brewer L, Conway O, Hickey A, Bennett K, Dolan E, Callaly E, Williams D. Cognitive Impairment, Vulnerability, and Mortality Post Ischemic Stroke: A Five-Year Follow-Up of the Action on Secondary Prevention Interventions and Rehabilitation in Stroke (ASPIRE-S) Cohort. J Stroke Cerebrovasc Dis. 2018 Sep;27(9):2466-2473. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.002. Epub 2018 May 24.
PubMed 29803601Grau-Sanchez J, Duarte E, Ramos-Escobar N, Sierpowska J, Rueda N, Redon S, Veciana de Las Heras M, Pedro J, Sarkamo T, Rodriguez-Fornells A. Music-supported therapy in the rehabilitation of subacute stroke patients: a randomized controlled trial. Ann N Y Acad Sci. 2018 Apr 1. doi: 10.1111/nyas.13590. Online ahead of print.
PubMed 29607506Zheng G, Zheng Y, Xiong Z, Ye B, Tao J, Chen L. Effect of Baduanjin exercise on cognitive function in patients with post-stroke cognitive impairment: study protocol for a randomised controlled trial. BMJ Open. 2018 Jun 22;8(6):e020954. doi: 10.1136/bmjopen-2017-020954.
PubMed 29934385Pang MYC, Yang L, Ouyang H, Lam FMH, Huang M, Jehu DA. Dual-Task Exercise Reduces Cognitive-Motor Interference in Walking and Falls After Stroke. Stroke. 2018 Dec;49(12):2990-2998. doi: 10.1161/STROKEAHA.118.022157.
PubMed 30571419Thielman G, Roos M. A telehealth exercise program to improve cognition in people with stroke. Sci Rep. 2025 Jul 1;15(1):21109. doi: 10.1038/s41598-025-07064-9.
PubMed 40593106
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Exercise Program to Improve Cognition in People With Stroke
- ClinicalTrials.gov ID
- NCT05919251
- Acronym / sponsor ID
- CAPS / 1301299
- Keywords
- stroke, cognition, dual task, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saint Joseph's University, PhiladelphiaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Jun 2023 (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.
If a subject agrees to participate, the primary investigators will collect some basic information including age, height, and weight. Intake of some general questions regarding health will be performed and each subject will complete some tests that measure walking speed, cognition, and balance. During these tests participants will be asked to stand from a chair, walk up \& down a staircase, walk over objects in a forward, backward, and sideways directions, walk around objects in forward and backward directions. After completing those tests, participants will be asked to repeat them while doing another task such as counting out loud, naming objects, or passing an object from one hand to another.
Detailed description
After stroke, it has been noted that up to 70% of people have cognitive impairment , between 20-60% experience depression and most are significantly less active than healthy older adults. These deficits are particularly problematic as they affect quality of life, participation in community activities and lead to a cycle of declining function. In people post stroke, participation in exercise programs has been associated with improvements in cognitive function, but others have found no cognitive improvements. Other exercise programs have helped people with stroke with depression, decreased falls incidence, and improved walking activity, but other research shows a lack of carryover of exercise programs to participation in the community. Of note, some standard outcome measures used in this work are not sensitive to change and some disadvantage those with aphasia, while many have been almost exclusively paper and pencil tests. This research project will be using a battery of cognitive measures to capture change in participants.
The investigators will assess the person's ability to change their cognitive status by using functional tests with and without a cognitive challenge and compare changes with those seen in computerized testing as that represents the gold standard. This unique program attempts to combine multiple aspects that easily fit together including music and a group setting for socialization. The use of music to improve cognition as has been shown in other research studies to improve participation in exercise program. By linking cognitive retraining, low intensity exercise, group activities and music, the researchers of this project can determine if a movement program with these attributes can benefit individuals as a program of wellness, once their rehabilitation plans have been completed. The researchers are specifically interested in the effect on balance, activity and incidence of falls in people with chronic stroke. Additionally, the researchers will investigate the differences that this structured program will make on older adults who will act as a comparison group. This will bring insight into some of the additional challenges that people with stroke encounter on a daily basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- pretest posttest 2 groups x 2 test sessions
| Arm | Type | Receives |
|---|---|---|
| Healthy Older Adults | Active comparator | Behavioral: Ageless GraceThis subset of subject's have a fair history with this methodology and are being used as the comparator. Age matched older adults |
| Subject's Post Stroke | Experimental | Behavioral: Ageless GraceIndividuals post stroke have recently participated in this ongoing investigation in a live format but these subjects are now entered into a telehealth arm. In the future others will participate in the live format |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years of age
- 1 or more strokes at least 3 months ago
- Able to follow directions and talk with the researchers
- Able to safely exercise in a group setting when sitting as determined by your primary healthcare provider
- Retired or semi-retired
Key exclusion criteria (5 listed)
- Bone or joint problems that restrict your movement or walking
- Really high or low blood pressure or pulse
- Pain in your chest or difficulty breathing when you are sitting
- Any other neurological problems
- Lack of clearance provided to you by your primary health care provider
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 |
|---|---|---|
| Ageless GraceThis unique program attempts to combine multiple aspects that easily fit together including music and a group setting for socialization. The use of music to improve cognition as has been shown in other research studies to improve participation in exercise program. By linking cognitive retraining, low intensity exercise, group activities and music, the researchers of this project can determine if a movement program with these attributes can benefit individuals as a program of wellness once their rehabilitation plans have been completed. The researchers are specifically interested in the effect on balance, activity and incidence of falls in people with chronic stroke. Additionally, the researchers will investigate the differences that this structured program will make on older adults who will act as a comparison group. This will bring insight into some of the additional challenges that people with stroke encounter on a daily basis. | Behavioural | Healthy Older Adults, Subject's Post Stroke |
Primary outcome
Differences in cognitive and motor function in individuals post stroke compared to age matched older adults measured by time differential between various walking distances and these tasks with a cognitive activity challenge included.
Time frame: effects as a result of 24 sessions, approximately 12 weeks after the start of the program
The primary purpose is to determine the impact of a low intensity seated exercise program (24 sessions 2x/wk for 12 weeks) with cognitive training on dual task function
Differences in cognitive and motor function in individuals post stroke compared to age matched older adults will be measured by time differential between isolated motor tasks (number of sit to stands) and task with cognitive activity challenge.
Time frame: effects as a result of 24 sessions, approximately 12 weeks after the start of the program
The primary purpose is to determine the impact of a low intensity seated exercise program (24 sessions 2x/wk for 12 weeks) with cognitive training on dual task function
Differences in cognitive and motor function measured by time differential between isolated motor tasks (number of seated alternative limb marches) and tasks that include a cognitive activity challenge as well.
Time frame: effects as a result of 24 sessions, approximately 12 weeks after the start of the program
The primary purpose is to determine the impact of a low intensity seated exercise program (24 sessions 2x/wk for 12 weeks) with cognitive training on dual task function
1 secondary outcome
Walking monitors measurement
Time frame: effects of a 3 day baseline walking average (prior to the 24 sessions at 2x/wk) compared to a 3 day walking average post training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Results publication: PubMed 30354969Cumming TB, Bernhardt J, Lowe D, Collier J, Dewey H, Langhorne P, Thrift AG, Green A, Mohanraj R, Kramer SF, Churilov L, Linden T; AVERT Trial Collaboration group. Early Mobilization After Stroke Is Not Associated With Cognitive Outcome. Stroke. 2018 Sep;49(9):2147-2154. doi: 10.1161/STROKEAHA.118.022217.
- Results publication: PubMed 29803601Gaynor E, Rohde D, Large M, Mellon L, Hall P, Brewer L, Conway O, Hickey A, Bennett K, Dolan E, Callaly E, Williams D. Cognitive Impairment, Vulnerability, and Mortality Post Ischemic Stroke: A Five-Year Follow-Up of the Action on Secondary Prevention Interventions and Rehabilitation in Stroke (ASPIRE-S) Cohort. J Stroke Cerebrovasc Dis. 2018 Sep;27(9):2466-2473. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.002. Epub 2018 May 24.
- Results publication: PubMed 29607506Grau-Sanchez J, Duarte E, Ramos-Escobar N, Sierpowska J, Rueda N, Redon S, Veciana de Las Heras M, Pedro J, Sarkamo T, Rodriguez-Fornells A. Music-supported therapy in the rehabilitation of subacute stroke patients: a randomized controlled trial. Ann N Y Acad Sci. 2018 Apr 1. doi: 10.1111/nyas.13590. Online ahead of print.
- Results publication: PubMed 29934385Zheng G, Zheng Y, Xiong Z, Ye B, Tao J, Chen L. Effect of Baduanjin exercise on cognitive function in patients with post-stroke cognitive impairment: study protocol for a randomised controlled trial. BMJ Open. 2018 Jun 22;8(6):e020954. doi: 10.1136/bmjopen-2017-020954.
- Results publication: PubMed 30571419Pang MYC, Yang L, Ouyang H, Lam FMH, Huang M, Jehu DA. Dual-Task Exercise Reduces Cognitive-Motor Interference in Walking and Falls After Stroke. Stroke. 2018 Dec;49(12):2990-2998. doi: 10.1161/STROKEAHA.118.022157.
- Derived from this study: PubMed 40593106Thielman G, Roos M. A telehealth exercise program to improve cognition in people with stroke. Sci Rep. 2025 Jul 1;15(1):21109. doi: 10.1038/s41598-025-07064-9.
- Individual participant dataSharing planned: Yes. other researchers in the group are investigating other aspects and will need access
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
greg thielman, EdD principal investigator
Saint Joseph's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ageless Grace in people with Stroke and Cognitive Change, run by Saint Joseph's University, Philadelphia 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gregory T thielman, EdD (2155968680, gthielman@sju.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in cognitive and motor function in individuals post stroke compared to age matched older adults measured by time differential between various walking distances and these tasks with a cognitive activity challenge included. (time frame: effects as a result of 24 sessions, approximately 12 weeks after the start of the program). The study lists 3 primary outcomes in all. 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 NCT05919251, which also lists 6 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 26 Jun 2023.