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

Primary Purpose

Stroke, Cognitive Change, Neurological Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ageless Grace
Sponsored by
Saint Joseph's University, Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, cognition, dual task, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint Joseph's UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Older Adults

Subject's Post Stroke

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2023
Last Updated
June 15, 2023
Sponsor
Saint Joseph's University, Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT05919251
Brief Title
Influence of Cognition on Activity and Participation in People With Stroke
Acronym
CAPS
Official Title
A Telehealth Exercise Program to Improve Cognition in People With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Joseph's University, Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Change, Neurological Injury, Cognitive Impairment, Activity, Motor
Keywords
stroke, cognition, dual task, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pretest posttest 2 groups x 2 test sessions
Masking
ParticipantCare ProviderOutcomes 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
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Older Adults
Arm Type
Active Comparator
Arm Description
This subset of subject's have a fair history with this methodology and are being used as the comparator. Age matched older adults
Arm Title
Subject's Post Stroke
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Ageless Grace
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
effects as a result of 24 sessions, approximately 12 weeks after the start of the program
Title
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.
Description
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
Time Frame
effects as a result of 24 sessions, approximately 12 weeks after the start of the program
Title
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.
Description
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
Time Frame
effects as a result of 24 sessions, approximately 12 weeks after the start of the program
Secondary Outcome Measure Information:
Title
Walking monitors measurement
Description
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
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gregory T thielman, EdD
Phone
2155968680
Email
gthielman@sju.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Roos, PhD
Phone
2155968676
Email
mroos@sju.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
greg thielman, EdD
Organizational Affiliation
Saint Joseph's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph's University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gregory thielman, EdD
Phone
856-266-7863
Email
g.thielm@usciences.edu
First Name & Middle Initial & Last Name & Degree
Margaret Roos, PhD
Phone
2155968676
Email
mroos@sju.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30354969
Citation
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.
Results Reference
result
PubMed Identifier
29803601
Citation
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.
Results Reference
result
PubMed Identifier
29607506
Citation
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.
Results Reference
result
PubMed Identifier
29934385
Citation
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.
Results Reference
result
PubMed Identifier
30571419
Citation
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.
Results Reference
result

Learn more about this trial

Influence of Cognition on Activity and Participation in People With Stroke

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