Integrating Stroke Survivors Into Cardiac Rehabilitation

NCT ID: NCT03706105

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-05-30

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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention - Cardiac Rehabilitation

Group Type EXPERIMENTAL

Cardiac Rehabilitation

Intervention Type BEHAVIORAL

3 x week \~1 hour of exercise + education

Interventions

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Cardiac Rehabilitation

3 x week \~1 hour of exercise + education

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novant Health Heart and Vascular Institute

UNKNOWN

Sponsor Role collaborator

American Physical Therapy Association

OTHER

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Regan

Physical Therapist, PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stacy L Fritz, PT, PhD

Role: STUDY_DIRECTOR

University of South Carolina

Elizabeth Regan, DPT

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33499647 (View on PubMed)

Other Identifiers

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18-1001

Identifier Type: -

Identifier Source: org_study_id