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 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.

At the end of the day, a step counter will be attached to each subject's ankle and you asked to wear it when awake for the next 7 days. Investigators expect that the evaluation will last 1 hour. After 7 days, subjects will return the step counter to the researchers and begin the exercise classes. The exercise classes will occur 2 days per week for 8 weeks. In the class participants will be asked to perform gentle exercises and use memory to improve brain functioning. Each class is expected to last 1 hour. At the conclusion of the exercise classes, investigators will again perform the gait, balance and cognitive tasks as we did before each started the class. Once a subject finishes all the exercise classes and testing, investigators will call one every week to see if you have had any falls at home. The calls will go on for 6 months.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Cognitive Change; Neuroplasticity; Dual Task; Exercise Intervention
• 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 (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: gregory t thielman, EdD; Phone Number: 2155968680; Email: g.thielm@usciences.edu
• Study Contact Backup: Name: Margaret Roos, PhD; Phone Number: 2155968676; Email: m.roos@usciences.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of the Sciences
      • Contact: Gregory T Thielman, EdD; Phone Number: 215-596-8680; Email: g.thielm@usciences.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who have sustained a stroke will be recruited to participate in this research study.

Inclusion Criteria:

• Over 18 years of age with 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

Older adults in good health will be recruited to act as a comparison group

Inclusion Criteria:

• 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
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Health Older Adults; This subset of subject's have a fair history with this methodology and are being used as the comparator.	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: Subjects 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.	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
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 cognitive/motor function in individuals post stroke compared to age matched older adults	dual task processing speed (time differential between isolated motor task and task with cognitive activity challenge included)	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
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	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

Collaborators and Investigators

• Sponsor: University of the Sciences in Philadelphia
• Investigators: Principal Investigator: gregory t thielman, EdD, USciences

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): May 20, 2020
• Primary Completion (ANTICIPATED): October 20, 2022
• Study Completion (ANTICIPATED): December 20, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (ACTUAL): May 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: exercise; stroke; cognition; dual task
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• 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 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