An interventional study of Gentle Stretching in Heart Failure, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
Heart failure is common in adults and is the most common hospital diagnosis in older adults. Patients with heart failure suffer numerous distressing symptoms daily. Although palliative care can improve suffering, rural-dwelling heart failure patients have poor access to specialized palliative care. The investigators propose to pilot test a tele-health palliative care intervention, PALL-HEART, in rural dwelling heart failure patients who live in Virginia and Kentucky.
Study specific objectives are:
Primary Aims:
Secondary:
acceptability of the intervention for future refinement and large scale testing.
5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 3,737 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Education provided for optional use
Gentle Stretching for 60 minutes twice weekly
Behavioral: Gentle Stretching
60 minutes fo gentle stretching twice weekly for 8 weeks
Also known as: Exercise
Heart Failure Somatic Perception Scale Questionnaire
This questionnaire measures symptoms of heart failure - The 18-item Somatic Perception Scale asks participants how much they are bothered by 18 symptoms of heart failure in the past week using 5 response options ranging from 0 (I did not have the symptom) to 5 (extremely bothersome). Scores are summed, with higher values indicating higher symptom burden. Scores range from 0-90 with higher values indicating higher symptom burden.
Time frame: 10 weeks
PROMIS questionnaire
This questionnaire screens for symptoms of depression. The 8-item questionnaire assesses self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) in the past week. The questionnaire uses 5 response options ranging from 0 (never) to 5 (always). Scores are summed, with higher values indicating higher risk for depression. The total raw score is converted into a T-score. The T-score rescales the raw score into a standardized score. The final score is a standardized score with a mean of 50 and a standard deviation of 10.
Time frame: 10 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ)
This questionnaire measures quality of life in people with heart failure. This questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Overall scores are transformed to a range of 0-100, in which higher scores reflect better health status. There are summary scores within the KCCQ and the overall summary score is created by the mean of Physical Limitation Score, Total Symptom Score, Quality of Life Score, and Social Limitation Score.
Time frame: 10 weeks
The Resilience Scale
The Resilience Scale is a 25-item administered questionnaire that measures an individual's ability to adapt over time to stressors in life. Scores on the summated scale range from 25 to 175, with higher scores indicating higher resilience. All of the items are positively worded. Items are measured on a 7-point scale from 1(strongly disagree) to 7 (strongly agree). Responses are summed to produce a total score where a higher score indicates higher resilience.
Time frame: 10 weeks
Self-Care for Heart Failure Index Questionnaire (SCHFI)
The Self-Care for Heart Failure Index Questionnaire (SCHFI) is a 39-item measure of heart failure self-care. The items range from never (1) to always (5). There are 3 subscales: maintenance scale, symptom perception, confidence scale, and management scale. All of the scales are scored in the same way and a total score is not computed. Separate scores for each scale are computed separately. In general, to standardize a scale score, 1) determine the maximum possible scale score, 2) subtract the number of items from the possible score, and 3) divide 100 by that result to identify a constant for that scale. To score the scale, sum item responses, subtract the number of items answered, and multiply by the constant.The higher the score, the greater the ability to care for heart failure symptoms within each subscale.
Time frame: 10 weeks
Endurance
2 step test - step alternating knees upward for 2 minutes
Time frame: 10 weeks
upper body strength - we will measure bicep strength by the number of hand weight lifts
participants are instructed to perform as many arm curls as possible for 30 seconds
Time frame: 10 weeks
lower body strength - we will measure quadricep strength by the number of times siting and standing in 30 seconds
participants are instructed to sit and then to stand as many times as possible in 30 seconds
Time frame: 10 weeks
balance
stand on 1 leg for as long as possible
Time frame: 10 weeks
Plan to share: Yes — Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.
Supporting information: Study protocol, Sap, Csr, Analytic code
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Virginia