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Completed

NCT Number: NCT03706105

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation

Behavioral

3 x week ~1 hour of exercise + education

Primary outcomes

  1. 6-minute walk Test

    Time frame: Change in 6-minute walk test at 3 months

    Aerobic and Walking Capacity Measure

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • American Physical Therapy Association
  • Novant Health Heart and Vascular Institute

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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