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Integrating Stroke Survivors Into Cardiac Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706105
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
Novant Health Heart and Vascular Institute
American Physical Therapy Association
Information provided by (Responsible Party):
Elizabeth Regan, University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Cardiac Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrating Stroke Survivors Into Cardiac Rehabilitation
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention - Cardiac Rehabilitation Behavioral: Cardiac Rehabilitation
3 x week ~1 hour of exercise + education




Primary Outcome Measures :
  1. 6-minute walk Test [ Time Frame: Change in 6-minute walk test at 3 months ]
    Aerobic and Walking Capacity Measure


Secondary Outcome Measures :
  1. Walking Speed [ Time Frame: Change in Walking Speed at 3 months ]
    Self-Selected walking speed for 10 meters

  2. Timed Up and Go [ Time Frame: Change in timed up and go at 3 months ]
    Mobility Measure: timed movement from seated in a chair, walk 10 feet and return to sitting in a chair.

  3. Stroke Impact Scale [ Time Frame: Change in Stroke Impact Scale at 3 months ]
    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.

  4. Fatigue Severity Scale [ Time Frame: Change in Fatigue Severity Scale at 3 months ]
    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.

  5. Activities Specific Balance Confidence (ABC) Scale [ Time Frame: Change in ABC Scale at 3 months ]
    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.

  6. Readiness for Change Questionnaire [ Time Frame: Change in Readiness/Confidence in Behaviors at 3 months ]
    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.

  7. Patient Health Questionnaire 9 (PHQ9) [ Time Frame: Change in PHQ9 at 3 months ]
    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.

  8. Ferrans and Powers Quality of Life Questionnaire [ Time Frame: Change in Ferrans and Powers Quality of Life Questionnaire at 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706105


Locations
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United States, North Carolina
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
University of South Carolina
Novant Health Heart and Vascular Institute
American Physical Therapy Association
Investigators
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Study Director: Stacy L Fritz, PT, PhD University of South Carolina
Principal Investigator: Elizabeth Regan, DPT University of South Carolina
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Responsible Party: Elizabeth Regan, Physical Therapist, PhD Candidate, University of South Carolina
ClinicalTrials.gov Identifier: NCT03706105    
Other Study ID Numbers: 18-1001
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases