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Integrating Stroke Survivors Into Cardiac Rehabilitation

Integrating Stroke Survivors Into Cardiac Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03706105
Enrollment
29
Registered
2018-10-15
Start date
2018-07-01
Completion date
2020-05-30
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

BEHAVIORALCardiac Rehabilitation

3 x week \ 1 hour of exercise + education

Sponsors

Novant Health Heart and Vascular Institute
CollaboratorUNKNOWN
American Physical Therapy Association
CollaboratorOTHER
University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6-minute walk TestChange in 6-minute walk test at 3 monthsAerobic and Walking Capacity Measure

Secondary

MeasureTime frameDescription
Timed Up and GoChange in timed up and go at 3 monthsMobility Measure: timed movement from seated in a chair, walk 10 feet and return to sitting in a chair.
Stroke Impact ScaleChange in Stroke Impact Scale at 3 monthsQuality 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 ScaleChange in Fatigue Severity Scale at 3 monthsA 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.
Walking SpeedChange in Walking Speed at 3 monthsSelf-Selected walking speed for 10 meters
Readiness for Change QuestionnaireChange in Readiness/Confidence in Behaviors at 3 monthsThe 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)Change in PHQ9 at 3 monthsThe 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 QuestionnaireChange in Ferrans and Powers Quality of Life Questionnaire at 3 monthsFerrans 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.
Activities Specific Balance Confidence (ABC) ScaleChange in ABC Scale at 3 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026