Influence of Cognition on Activity and Participation in People With Stroke

NCT05919251 | Unknown DMC

• 1 other identifier: 1301299
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stroke, cognition, dual task, exercise

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  effects as a result of 24 sessions, approximately 12 weeks after the start of the program

Secondary Outcomes (1)

• Walking monitors measurement

  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

Study Arms (2)

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

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

Behavioral: Ageless Grace

Interventions

Ageless Grace 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.

Healthy Older Adults; Subject's Post Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Joseph's University, Philadelphia: lead

Study Sites (1)

Saint Joseph's University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 30354969 RESULT

• 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.

  PMID: 29803601 RESULT

• 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.

  PMID: 29607506 RESULT

• 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.

  PMID: 29934385 RESULT

• 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.

  PMID: 30571419 RESULT

• 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.

  PMID: 40593106 DERIVED

MeSH Terms

Conditions

Stroke; Trauma, Nervous System; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• greg thielman, EdD

  Saint Joseph's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gregory T thielman, EdD

CONTACT

2155968680; gthielman@sju.edu

Margaret Roos, PhD

CONTACT

2155968676; mroos@sju.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pretest posttest 2 groups x 2 test sessions

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 26, 2023
• Study Start: June 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: must be a faculty member

Locations

US (1)