Integrating Stroke Survivors Into Cardiac Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Cardiac Rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - Cardiac Rehabilitation	Behavioral: Cardiac Rehabilitation; 3 x week ~1 hour of exercise + education

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: American Physical Therapy Association; Novant Health Heart and Vascular Institute
• Investigators: Study Director: Stacy L Fritz, PT, PhD, University of South Carolina; Principal Investigator: Elizabeth Regan, DPT, University of South Carolina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 18-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No