Back to resultsCardiac Rehabilitation of Stroke Survivors (SRP-CROSS) (SRP-CROSS)
Primary Purpose
Stroke, Cerebrovascular Accident
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring cardiac rehabilitation, stroke, stroke rehabilitation, stroke recovery, exercise, cardiovascular disease, cardiovascular function, cognitive function, physical function, neurorehabilitation, transition of care post stroke
Eligibility Criteria
Inclusion Criteria: 18 years or older Stroke diagnosis (ischemic or hemorrhagic) / radiologic evidence of acute stroke Medically cleared by a cardiologist for participation in the cardiac rehabilitation program with no contraindications to cardiac rehabilitation per American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines Ability to stand and walk with or without an assistive device for 10 feet safely, with or without assistance from another person Ability to transfer on/off the recumbent bike with or without an assistive device safely, with or without assistance from another person Ability to follow simple commands and communicate pain or distress Admission to an Inpatient Rehabilitation Facility post-stroke Signed informed consent form Exclusion Criteria: Presence of subarachnoid hemorrhage, intracranial aneurysm, intracranial hemangioma, or arteriovenous malformation Medical disorders that preclude participation in the study as determined by the Principal Investigator. Inability to have baseline assessment within 45 days post-stroke diagnosis Patient considered unable to comply with study requirements Known terminal illness with life expectancy less than 1 year Compliant diagnosis eligible for traditional cardiac rehabilitation covered by insurance Unable to understand/speak English
Sites / Locations
- Hackensack Meridian Health - JFK Johnson Rehabilitation InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cardiac rehabilitation group
Standard of care
Arm Description
Traditional medically supervised center-based cardiac rehabilitation program; including 36 sessions (30-50 minutes) of a progressive exercise program and educational sessions for cardiovascular disease (CVD) risk factors.
Depending on functional deficits, conventional rehabilitation therapies can include physical therapy, occupational therapy, and/or speech therapy sessions with 2-3 visits per week. Participants will receive their standard of care therapies as prescribed by their treating physicians.
Outcomes
Primary Outcome Measures
6-Minute Walk Test (6MWT)
Mean change in 6MWT score from baseline (30 days post-stroke) to 120 days post-stroke.
Secondary Outcome Measures
MET-min - (Metabolic Equivalent of Task - minutes)
Mean change in MET-min score from baseline (30 days post-stroke) to 120 days post-stroke.
AM-PAC - (Activity Measure for Post Acute Care)
Mean change in AM-PAC score from baseline (30 days post-stroke) to 120 days post-stroke. AM-PAC is a questionnaire that evaluates functional outcomes across three domains: basic mobility, daily activity, and applied cognitive. Standardized scores range from -11.95 to 104.9 for basic mobility, from -2.73 to 115.4 for daily activities, and from 6.84 to 68.28 for applied cognition with higher scores representing a better function.
MoCA - (Montreal Cognitive Assessment)
Mean change in MoCA score from baseline (30 days post-stroke) to 120 days post-stroke. MoCA is a 16-item test assessing multiple cognitive domains with a score range from 0-30 with higher scores representing a better function.
SS-QOL - (Stroke specific Quality of Life)
Mean change in SS-QOL score from baseline (30 days post-stroke) to 120 days post-stroke. SS-QOL is a self-reported questionnaire containing 49 item questions covering 12 domains with a score range of 49-245 with higher scores representing better function.
PHQ-9 - (Patient Health Questionnaire -9)
Mean change in PHQ-9 score from baseline (30 days post-stroke) to 120 days post-stroke. The PHQ-9 is a self-administered questionnaire designed to diagnose and evaluate depression with a score range 0-27.
All-cause hospital readmission
All-cause hospital readmission rates at 1-year post-stroke
Recurrent stroke rate
Recurrent stroke rates at 1-year post stroke
All-cause mortality rate
All-cause mortality rates at 1-year post stroke
AM-PAC - (Activity Measure for Post Acute Care)
Mean change in AM-PAC score from baseline (30 days post stroke) to 1-year post stroke. AM-PAC is a questionnaire that evaluates functional outcomes across three domains: basic mobility, daily activity, and applied cognitive. Standardized scores range from -11.95 to 104.9 for basic mobility, from -2.73 to 115.4 for daily activities, and from 6.84 to 68.28 for applied cognition with higher scores representing a better function.
SS-QOL - (Stroke specific Quality of Life)
Mean change in SS-QOL score from baseline (30 days post stroke) to 1-year post stroke. SS-QOL is a self-reported questionnaire containing 49 item questions covering 12 domains with a score range of 49-245 with higher scores representing better function.
mRS - (Modified Rankin Scale)
Mean change in mRS score from baseline (30 days post stroke) to 120 days post stroke. The mRS is a questionnaire to assess the level of disability and functional independence in daily activities with reference to pre-stroke activities. The scale is scored 0-6 where 0 indicates lack of symptoms and the score 6 indicates death.
Picture Your Plate (PYP)
Mean change in PYP score from baseline (30 days post stroke) to 120 days post stroke. Picture Your Plate is a brief 48-question dietary assessment questionnaire with a total score ranging from 0 to 96 with higher scores representing an unhealthy diet.
Full Information
NCT ID
NCT05651945
First Posted
December 7, 2022
Last Updated
May 17, 2023
Sponsor
Hackensack Meridian Health
Collaborators
The Cardiovascular Institute of New Jersey at Rutgers Robert Wood Johnson Medical School
1. Study Identification
Unique Protocol Identification Number
NCT05651945
Brief Title
Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)
Acronym
SRP-CROSS
Official Title
Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
January 20, 2026 (Anticipated)
Study Completion Date
January 20, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
Collaborators
The Cardiovascular Institute of New Jersey at Rutgers Robert Wood Johnson Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines the effectiveness of the cardiac rehabilitation program for stroke patients. The study will examine if patients with stroke, who receive cardiac rehabilitation in addition to their standard of care treatments, demonstrate improved recovery of function. It will also examine if these patients have reduced hospital readmission, reduced rate of recurrent stroke, and mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident
Keywords
cardiac rehabilitation, stroke, stroke rehabilitation, stroke recovery, exercise, cardiovascular disease, cardiovascular function, cognitive function, physical function, neurorehabilitation, transition of care post stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac rehabilitation group
Arm Type
Experimental
Arm Description
Traditional medically supervised center-based cardiac rehabilitation program; including 36 sessions (30-50 minutes) of a progressive exercise program and educational sessions for cardiovascular disease (CVD) risk factors.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Depending on functional deficits, conventional rehabilitation therapies can include physical therapy, occupational therapy, and/or speech therapy sessions with 2-3 visits per week. Participants will receive their standard of care therapies as prescribed by their treating physicians.
Intervention Type
Other
Intervention Name(s)
Cardiac rehabilitation program
Intervention Description
The cardiac rehabilitation program is an outpatient exercise intervention consisting of 36 sessions (30-50 minutes) of a progressive exercise program. Participants are closely monitored throughout the sessions using a telemetry monitor and are supervised by a team of cardiac rehabilitation nurses and exercise physiologists. In addition to the exercise program, participants will receive educational sessions for cardiovascular disease (CVD) risk factors including: 1) Diet/Nutrition, 2) Smoking cessation, 3) Physical activity, 4) Medication management/adherence and 5) Behavior change. As a part of the program, based on the initial assessment results, patients are referred to a rehabilitation psychologist or a dietician for consultation and evaluation if needed. In addition, participants will also receive their standard of care therapies as prescribed by their treating physicians.
Primary Outcome Measure Information:
Title
6-Minute Walk Test (6MWT)
Description
Mean change in 6MWT score from baseline (30 days post-stroke) to 120 days post-stroke.
Time Frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.
Secondary Outcome Measure Information:
Title
MET-min - (Metabolic Equivalent of Task - minutes)
Description
Mean change in MET-min score from baseline (30 days post-stroke) to 120 days post-stroke.
Time Frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.
Title
AM-PAC - (Activity Measure for Post Acute Care)
Description
Mean change in AM-PAC score from baseline (30 days post-stroke) to 120 days post-stroke. AM-PAC is a questionnaire that evaluates functional outcomes across three domains: basic mobility, daily activity, and applied cognitive. Standardized scores range from -11.95 to 104.9 for basic mobility, from -2.73 to 115.4 for daily activities, and from 6.84 to 68.28 for applied cognition with higher scores representing a better function.
Time Frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.
Title
MoCA - (Montreal Cognitive Assessment)
Description
Mean change in MoCA score from baseline (30 days post-stroke) to 120 days post-stroke. MoCA is a 16-item test assessing multiple cognitive domains with a score range from 0-30 with higher scores representing a better function.
Time Frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke.
Title
SS-QOL - (Stroke specific Quality of Life)
Description
Mean change in SS-QOL score from baseline (30 days post-stroke) to 120 days post-stroke. SS-QOL is a self-reported questionnaire containing 49 item questions covering 12 domains with a score range of 49-245 with higher scores representing better function.
Time Frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke
Title
PHQ-9 - (Patient Health Questionnaire -9)
Description
Mean change in PHQ-9 score from baseline (30 days post-stroke) to 120 days post-stroke. The PHQ-9 is a self-administered questionnaire designed to diagnose and evaluate depression with a score range 0-27.
Time Frame
Change from Baseline (30 days post-stroke) to 120 days post-stroke
Title
All-cause hospital readmission
Description
All-cause hospital readmission rates at 1-year post-stroke
Time Frame
1-year post-stroke
Title
Recurrent stroke rate
Description
Recurrent stroke rates at 1-year post stroke
Time Frame
1-year post stroke
Title
All-cause mortality rate
Description
All-cause mortality rates at 1-year post stroke
Time Frame
1-year post stroke
Title
AM-PAC - (Activity Measure for Post Acute Care)
Description
Mean change in AM-PAC score from baseline (30 days post stroke) to 1-year post stroke. AM-PAC is a questionnaire that evaluates functional outcomes across three domains: basic mobility, daily activity, and applied cognitive. Standardized scores range from -11.95 to 104.9 for basic mobility, from -2.73 to 115.4 for daily activities, and from 6.84 to 68.28 for applied cognition with higher scores representing a better function.
Time Frame
1-year post stroke
Title
SS-QOL - (Stroke specific Quality of Life)
Description
Mean change in SS-QOL score from baseline (30 days post stroke) to 1-year post stroke. SS-QOL is a self-reported questionnaire containing 49 item questions covering 12 domains with a score range of 49-245 with higher scores representing better function.
Time Frame
1-year post stroke
Title
mRS - (Modified Rankin Scale)
Description
Mean change in mRS score from baseline (30 days post stroke) to 120 days post stroke. The mRS is a questionnaire to assess the level of disability and functional independence in daily activities with reference to pre-stroke activities. The scale is scored 0-6 where 0 indicates lack of symptoms and the score 6 indicates death.
Time Frame
Change from Baseline (30 days post stroke) to 120 days post stroke
Title
Picture Your Plate (PYP)
Description
Mean change in PYP score from baseline (30 days post stroke) to 120 days post stroke. Picture Your Plate is a brief 48-question dietary assessment questionnaire with a total score ranging from 0 to 96 with higher scores representing an unhealthy diet.
Time Frame
Change from Baseline (30 days post stroke) to 120 days post stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Stroke diagnosis (ischemic or hemorrhagic) / radiologic evidence of acute stroke
Medically cleared by a cardiologist for participation in the cardiac rehabilitation program with no contraindications to cardiac rehabilitation per American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines
Ability to stand and walk with or without an assistive device for 10 feet safely, with or without assistance from another person
Ability to transfer on/off the recumbent bike with or without an assistive device safely, with or without assistance from another person
Ability to follow simple commands and communicate pain or distress
Admission to an Inpatient Rehabilitation Facility post-stroke
Signed informed consent form
Exclusion Criteria:
Presence of subarachnoid hemorrhage, intracranial aneurysm, intracranial hemangioma, or arteriovenous malformation
Medical disorders that preclude participation in the study as determined by the Principal Investigator.
Inability to have baseline assessment within 45 days post-stroke diagnosis
Patient considered unable to comply with study requirements
Known terminal illness with life expectancy less than 1 year
Compliant diagnosis eligible for traditional cardiac rehabilitation covered by insurance
Unable to understand/speak English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hayk Petrosyan, Ph.D.
Phone
732-321-7000
Ext
65979
Email
hayk.petrosyan@hmhn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara J Cuccurullo, MD
Organizational Affiliation
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Talya K Fleming, MD
Organizational Affiliation
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayk Petrosyan, PhD
Phone
732-321-7000
Ext
65979
Email
hayk.petrosyan@hmhn.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)
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