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Influence of Cognition on Activity and Participation in People With Stroke

A Telehealth Exercise Program to Improve Cognition in People With Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05919251
Acronym
CAPS
Enrollment
30
Registered
2023-06-26
Start date
2020-06-01
Completion date
2024-12-31
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activity, Motor, Cognitive Change, Cognitive Impairment, Neurological Injury, Stroke

Keywords

stroke, cognition, dual task, exercise

Brief 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. 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.

Interventions

BEHAVIORALAgeless Grace

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.

Sponsors

Saint Joseph's University, Philadelphia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants are not aware of other arm of study ongoing. Care providers are only part of the training arm that they are involved in. Independent Outcomes assessor is performing all testing

Intervention model description

pretest posttest 2 groups x 2 test sessions

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Subjects who have sustained a stroke * 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 Inclusion Criteria: Older adults in good health * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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.effects as a result of 24 sessions, approximately 12 weeks after the start of the programThe 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.effects as a result of 24 sessions, approximately 12 weeks after the start of the programThe 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.effects as a result of 24 sessions, approximately 12 weeks after the start of the programThe 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

Secondary

MeasureTime frameDescription
Walking monitors measurementeffects of a 3 day baseline walking average (prior to the 24 sessions at 2x/wk) compared to a 3 day walking average post trainingThe 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

Countries

United States

Contacts

Primary Contactgregory T thielman, EdD
gthielman@sju.edu2155968680
Backup ContactMargaret Roos, PhD
mroos@sju.edu2155968676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026