Influence of Cognition on Activity and Participation in People With Stroke (CAPS)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Cognitive Impairment; Cognitive Change; Neurological Injury; Activity, Motor
• Intervention / Treatment: Behavioral: Ageless Grace

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: gregory T thielman, EdD; Phone Number: 2155968680; Email: gthielman@sju.edu
• Study Contact Backup: Name: Margaret Roos, PhD; Phone Number: 2155968676; Email: mroos@sju.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Saint Joseph's University
      • Contact: Margaret Roos, PhD; Phone Number: 2155968676; Email: mroos@sju.edu
      • Contact: gregory thielman, EdD; Phone Number: 856-266-7863; Email: g.thielm@usciences.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: 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.
Experimental: 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Saint Joseph's University, Philadelphia
• Investigators: Principal Investigator: greg thielman, EdD, Saint Joseph's University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: stroke, cognition, dual task, exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Stroke; Trauma, Nervous System
• Other Study ID Numbers: 1301299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: other researchers in the group are investigating other aspects and will need access
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: must be a faculty member
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No