Integrating Stroke Survivors Into Cardiac Rehabilitation
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|ClinicalTrials.gov Identifier: NCT03706105|
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Cardiac Rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Intervention - Cardiac Rehabilitation||
Behavioral: Cardiac Rehabilitation
3 x week ~1 hour of exercise + education
- 6-minute walk Test [ Time Frame: Change in 6-minute walk test at 3 months ]Aerobic and Walking Capacity Measure
- Walking Speed [ Time Frame: Change in Walking Speed at 3 months ]Self-Selected walking speed for 10 meters
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, North Carolina|
|Novant Health Heart and Vascular Institute|
|Charlotte, North Carolina, United States, 28204|
|Study Director:||Stacy L Fritz, PT, PhD||University of South Carolina|
|Principal Investigator:||Elizabeth Regan, DPT||University of South Carolina|