Integrating Stroke Survivors Into Cardiac Rehabilitation

Study Overview
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Brief Summary
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The intervention trial will examine the effectiveness and feasibility of integrating stroke survivors into an existing hospital-based cardiac rehabilitation program at Novant Health in Charlotte, NC. Stroke survivors will be recruited through hospital system providers and physical therapists (PTs) for entry into a multidisciplinary, three-month cardiac rehabilitation program. This program consists of three sessions per week of supervised cardiovascular endurance and strength training, stretching, relaxation and education. Participants will be stroke survivors, have completed formal physical and occupational rehabilitation (if applicable), and have treating provider approval.

Official Title
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Integrating Stroke Survivors Into Cardiac Rehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Cardiac Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of stroke Completion of physical and occupational therapy (if applicable) Clearance by treating medical provider Ability to walk at least 40 meters independently (with or without assistive device) Ability to transfer sit to stand without assistance Ability to follow instructions and provide information on exertion, pain and distress Exclusion Criteria: Acute medical problem rendering exercise unsafe Significant pain that prevents standing or interferes with movement History of additional, non-stroke, neurological condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Cardiac Rehabilitation<br> | Behavioral: Cardiac Rehabilitation<br>* 3 x week  1 hour of exercise + education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk Test | Aerobic and Walking Capacity Measure | Change in 6-minute walk test at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Speed | Self-Selected walking speed for 10 meters | Change in Walking Speed at 3 months | 
| Timed Up and Go | Mobility Measure: timed movement from seated in a chair, walk 10 feet and return to sitting in a chair. | Change in timed up and go at 3 months | 
| Stroke Impact Scale | Quality of Life Questionnaire evaluating difficulty after stroke in 8 domains: strength, hand function, activities of daily living, mobility, communication, emotion, memory/thinking, participation/role function. Score is 0-100 in each domain and is transformed using the equation Domain score = (mean item score - 1)/4 * 100. Higher Scores indicate less impact of stroke. | Change in Stroke Impact Scale at 3 months | 
| Fatigue Severity Scale | A scale measuring the perceived impact of fatigue on life activities. Total score is 9-63 with a higher score indicating more fatigue severity and impact. | Change in Fatigue Severity Scale at 3 months | 
| Activities Specific Balance Confidence (ABC) Scale | The Activities Specific Balance Confidence scale measures an individual's confidence in performing 16 activities without loss of balance. Possible scores are 0-100 with higher scores indicating higher balance confidence. | Change in ABC Scale at 3 months | 
| Readiness for Change Questionnaire | The readiness for change questionnaire evaluates self-perception of readiness and confidence in exercise, physical activity and overall wellness behaviors. Readiness score is 3-15 with higher scores indicating higher readiness, and confidence score 3-9 with a higher score indicating more confidence in behavior. | Change in Readiness/Confidence in Behaviors at 3 months | 
| Patient Health Questionnaire 9 (PHQ9) | The patient health questionnaire is a 9 question self report measure of depression and depression severity. The score is 0-27 with a higher score indicating more severe depression. | Change in PHQ9 at 3 months | 
| Ferrans and Powers Quality of Life Questionnaire | Ferrans and Powers Quality of Life questionnaire is a measure of satisfaction and importance of 7 domains (health, healthcare, self-care, energy, family/friends support, engagement in life activities, happiness). Raw scores are converted to overall scores by weighting satisfaction by importance and adjusting for unanswered questions. Total scores are 0-30 with higher scores indicating a higher quality of life. | Change in Ferrans and Powers Quality of Life Questionnaire at 3 months |