Influence of Cognition on Activity and Participation in People With Stroke

NCT ID: NCT05919251

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Healthy Older Adults

This subset of subject's have a fair history with this methodology and are being used as the comparator. Age matched older adults

Group Type: ACTIVE_COMPARATOR

Ageless Grace

Intervention Type: BEHAVIORAL

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.

Subject's Post Stroke

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

Group Type: EXPERIMENTAL

Ageless Grace

Intervention Type: BEHAVIORAL

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

Ageless 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saint Joseph's University, Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

greg thielman, EdD

Role: PRINCIPAL_INVESTIGATOR

Saint Joseph's University

Locations

Saint Joseph's University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

gregory T thielman, EdD

Role: CONTACT

gthielman@sju.edu

2155968680

Margaret Roos, PhD

Role: CONTACT

mroos@sju.edu

2155968676

Facility Contacts

gregory thielman, EdD

Role: primary

g.thielm@usciences.edu

856-266-7863

Margaret Roos, PhD

Role: backup

mroos@sju.edu

2155968676

References

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.

Reference Type: RESULT

PMID: 30354969 (View on PubMed)

Gaynor 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.

Reference Type: RESULT

PMID: 29803601 (View on PubMed)

Grau-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.

Reference Type: RESULT

PMID: 29607506 (View on PubMed)

Zheng 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.

Reference Type: RESULT

PMID: 29934385 (View on PubMed)

Pang 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.

Reference Type: RESULT

PMID: 30571419 (View on PubMed)

Thielman 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.

Reference Type: DERIVED

PMID: 40593106 (View on PubMed)

Other Identifiers

1301299

Identifier Type: -

Identifier Source: org_study_id

NCT05392270

Identifier Type: -

Identifier Source: nct_alias