Clinical trial NCT03706105: Integrating Stroke Survivors Into Cardiac Rehabilitation
Official title: Integrating Stroke Survivors Into Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Novant Health Heart and Vascular Institute
name: American Physical Therapy Association
First posted: 2018-10-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 6-minute walk Test
timeFrame: Change in 6-minute walk test at 3 months
Secondary outcomes:
measure: Walking Speed
timeFrame: Change in Walking Speed at 3 months
measure: Timed Up and Go
timeFrame: Change in timed up and go at 3 months
measure: Stroke Impact Scale
timeFrame: Change in Stroke Impact Scale at 3 months
measure: Fatigue Severity Scale
timeFrame: Change in Fatigue Severity Scale at 3 months
measure: Activities Specific Balance Confidence (ABC) Scale
timeFrame: Change in ABC Scale at 3 months
measure: Readiness for Change Questionnaire
timeFrame: Change in Readiness/Confidence in Behaviors at 3 months
measure: Patient Health Questionnaire 9 (PHQ9)
timeFrame: Change in PHQ9 at 3 months
measure: Ferrans and Powers Quality of Life Questionnaire
timeFrame: Change in Ferrans and Powers Quality of Life Questionnaire at 3 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
Study officials:
affiliation: University of South Carolina
name: Stacy L Fritz, PT, PhD
role: STUDY_DIRECTOR
affiliation: University of South Carolina
name: Elizabeth Regan, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Regan EW, Handlery R, Stewart JC, Pearson JL, Wilcox S, Fritz S. Integrating Survivors of Stroke Into Exercise-Based Cardiac Rehabilitation Improves Endurance and Functional Strength. J Am Heart Assoc. 2021 Feb 2;10(3):e017907. doi: 10.1161/JAHA.120.017907. Epub 2021 Jan 27.