NCT03706105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

April 25, 2018

Last Update Submit

November 2, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk Test

    Aerobic and Walking Capacity Measure

    Change in 6-minute walk test at 3 months

Secondary Outcomes (8)

  • Walking Speed

    Change in Walking Speed at 3 months

  • Timed Up and Go

    Change in timed up and go at 3 months

  • Stroke Impact Scale

    Change in Stroke Impact Scale at 3 months

  • Fatigue Severity Scale

    Change in Fatigue Severity Scale at 3 months

  • Activities Specific Balance Confidence (ABC) Scale

    Change in ABC Scale at 3 months

  • +3 more secondary outcomes

Study Arms (1)

Intervention - Cardiac Rehabilitation

EXPERIMENTAL
Behavioral: Cardiac Rehabilitation

Interventions

Cardiac RehabilitationBEHAVIORAL

3 x week \~1 hour of exercise + education

Intervention - Cardiac Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute medical problem rendering exercise unsafe
  • Significant pain that prevents standing or interferes with movement
  • History of additional, non-stroke, neurological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

Related Publications (1)

  • 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.

    PMID: 33499647DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stacy L Fritz, PT, PhD

    University of South Carolina

    STUDY DIRECTOR

  • Elizabeth Regan, DPT

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, PhD Candidate

Study Record Dates

First Submitted

April 25, 2018

First Posted

October 15, 2018

Study Start

July 1, 2018

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)