Integrating Stroke Survivors Into Cardiac Rehabilitation

Stroke Clinical Trial

Official title:

Integrating Stroke Survivors Into Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706105
• Other study ID #: 18-1001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: November 2020
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Cardiac Rehabilitation
3 x week ~1 hour of exercise + education

Locations

Country	Name	City	State
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	American Physical Therapy Association, Novant Health Heart and Vascular Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk Test	Aerobic and Walking Capacity Measure	Change in 6-minute walk test at 3 months
Secondary	Walking Speed	Self-Selected walking speed for 10 meters	Change in Walking Speed at 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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