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Integrating Stroke Survivors Into Cardiac Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Rehabilitation
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novant Health Heart and Vascular Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention - Cardiac Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

6-minute walk Test
Aerobic and Walking Capacity Measure

Secondary Outcome Measures

Walking Speed
Self-Selected walking speed for 10 meters
Timed Up and Go
Mobility Measure: timed movement from seated in a chair, walk 10 feet and return to sitting in a chair.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 25, 2018
Last Updated
November 2, 2020
Sponsor
University of South Carolina
Collaborators
Novant Health Heart and Vascular Institute, American Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT03706105
Brief Title
Integrating Stroke Survivors Into Cardiac Rehabilitation
Official Title
Integrating Stroke Survivors Into Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Novant Health Heart and Vascular Institute, American Physical Therapy Association

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - Cardiac Rehabilitation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cardiac Rehabilitation
Intervention Description
3 x week ~1 hour of exercise + education
Primary Outcome Measure Information:
Title
6-minute walk Test
Description
Aerobic and Walking Capacity Measure
Time Frame
Change in 6-minute walk test at 3 months
Secondary Outcome Measure Information:
Title
Walking Speed
Description
Self-Selected walking speed for 10 meters
Time Frame
Change in Walking Speed at 3 months
Title
Timed Up and Go
Description
Mobility Measure: timed movement from seated in a chair, walk 10 feet and return to sitting in a chair.
Time Frame
Change in timed up and go at 3 months
Title
Stroke Impact Scale
Description
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.
Time Frame
Change in Stroke Impact Scale at 3 months
Title
Fatigue Severity Scale
Description
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.
Time Frame
Change in Fatigue Severity Scale at 3 months
Title
Activities Specific Balance Confidence (ABC) Scale
Description
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.
Time Frame
Change in ABC Scale at 3 months
Title
Readiness for Change Questionnaire
Description
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.
Time Frame
Change in Readiness/Confidence in Behaviors at 3 months
Title
Patient Health Questionnaire 9 (PHQ9)
Description
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.
Time Frame
Change in PHQ9 at 3 months
Title
Ferrans and Powers Quality of Life Questionnaire
Description
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.
Time Frame
Change in Ferrans and Powers Quality of Life Questionnaire at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy L Fritz, PT, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elizabeth Regan, DPT
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novant Health Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33499647
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.
Results Reference
derived

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Integrating Stroke Survivors Into Cardiac Rehabilitation

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