Heart FailurePall-HeartNCT04120857
A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
A study testing Gentle Stretching in people with Heart Failure, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Gentle Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure with reduced ejection fraction or Heart failure with preserved ejection fraction as seen by problem list in the EMR, is a patient in the heart failure clinic, or general cardiology clinic.
- ability to read, write and understand English;
- agree to participate and give informed consent;
- 19 years of age and older;
- telephone access;
- and NYHA class I-III with no changes in medications in 30 days (i.e. medical therapy is optimized).
Who cannot join
- are pregnant and/or breast feeding (self-reported)
- have a history of non-adherence with medications (as described by their provider or medical record);
- have had a hospitalization within the last 3 months for HF;
- have unstable angina; CABG, MI or biventricular pacemaker less than 6 weeks prior;
- have orthopedic impediments to stretching exercise;
- have severe COPD with a forced expiratory volume in one second less than 1 liter as measured by spirometry;
Show all 15Show fewer
- have severe stenotic valvular disease;
- have a history of resuscitated sudden cardiac death without subsequent placement of an implantable cardioverter defibrillator;
- exercise more than 3 times weekly; currently engage in yoga at least 1 time per week;
- have cognitive impairment (as measured by the Mini-Cog)
- are living in a nursing home
- history of pulmonary arterial hypertension (PASP>60mmHg)
- other serious life-limiting co-morbidity, e.g. end stage cancer
- post-heart transplant (s/p OHT) or Left Ventricular Assist Device (LVAD)
- New York Heart Association Functional Class IV
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
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:
Read more
Primary Aims:
- AIM 1: Compare HF patients who participate in a home-delivered tablet-based HF health education and gentle stretching intervention, to a health education (HE) group on: a) HF symptoms (weight gain, breathlessness, fatigue), b) psychological symptoms (depression, diminished QOL, resilience, self-care, and heart rate variability), c) physical function (endurance, strength, balance), and d) health care utilization rates (ED visits, office visits, hospitalizations).
- Hypothesis 1: HF symptoms (weight gain, breathlessness, fatigue), psychological symptoms (depression, diminished QOL, resilience, self-care), physical function (endurance, strength, balance) will improve in the intervention group.
- Hypothesis 2: Health care utilization rates (ED visits, office visits, hospitalizations) will decrease in the intervention group.
Secondary:
- AIM 2: Acceptability - Acceptability of the intervention will be determined using: a) participation and satisfaction rates (participant logs), b) intervention retention rates, and c) barriers to participation (technology and participant motivation issues).
- Hypothesis: Subjects in the intervention group will have >80% participation and satisfaction rates and be willing to identify barriers to participation. acceptability of the intervention for future refinement and large scale testing.
- Conditions
- Heart Failure
- Being tested
- Gentle Stretching
- Keywords
- stretching, exercise
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle StretchingBehavioural
Also called Exercise
60 minutes fo gentle stretching twice weekly for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Educational Control Group | No intervention | Education provided for optional use |
| Gentle Stretching and Education | Experimental | Gentle Stretching for 60 minutes twice weekly Receives: Behavioral: Gentle Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Endurance
2 step test - step alternating knees upward for 2 minutes
Measured: 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
Measured: 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
Measured: 10 weeks
balance
stand on 1 leg for as long as possible
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Jun 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Principal investigator, Jill Howie Esquivel, PhD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120857
- Sponsor's protocol ID
- 21320
- Acronym
- Pall-Heart
- Status last verified
- Nov 2020
- First submitted
- 24 Sep 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.
Publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8.
PubMed 26727546Zambroski CH, Moser DK, Bhat G, Ziegler C. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005 Sep;4(3):198-206. doi: 10.1016/j.ejcnurse.2005.03.010.
PubMed 15916924Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
PubMed 28705314Braun LT, Grady KL, Kutner JS, Adler E, Berlinger N, Boss R, Butler J, Enguidanos S, Friebert S, Gardner TJ, Higgins P, Holloway R, Konig M, Meier D, Morrissey MB, Quest TE, Wiegand DL, Coombs-Lee B, Fitchett G, Gupta C, Roach WH Jr; American Heart Association Advocacy Coordinating Committee. Palliative Care and Cardiovascular Disease and Stroke: A Policy Statement From the American Heart Association/American Stroke Association. Circulation. 2016 Sep 13;134(11):e198-225. doi: 10.1161/CIR.0000000000000438. Epub 2016 Aug 8.
PubMed 27503067Dracup K, Moser DK, Pelter MM, Nesbitt TS, Southard J, Paul SM, Robinson S, Cooper LS. Randomized, controlled trial to improve self-care in patients with heart failure living in rural areas. Circulation. 2014 Jul 15;130(3):256-64. doi: 10.1161/CIRCULATIONAHA.113.003542. Epub 2014 May 9.
PubMed 24815499Donesky D, Selman L, McDermott K, Citron T, Howie-Esquivel J. Evaluation of the Feasibility of a Home-Based TeleYoga Intervention in Participants with Both Chronic Obstructive Pulmonary Disease and Heart Failure. J Altern Complement Med. 2017 Sep;23(9):713-721. doi: 10.1089/acm.2015.0279. Epub 2017 Jun 27.
PubMed 28654302Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PubMed 16204405Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 2000 Jan 8;320(7227):114-6. doi: 10.1136/bmj.320.7227.114. No abstract available.
PubMed 10625273Martyn Hammersley. Challenging Relativism: The Problem of Assessment Criteria. Qual Inq. 2009 Jan 1;15(1):3-29.
Clive Seale. Quality in Qualitative Research. Qual Inq. 1999 Dec 1;5(4):465-78
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
- ClinicalTrials.gov ID
- NCT04120857
- Acronym / sponsor ID
- Pall-Heart / 21320
- Conditions
- Heart Failure
- Keywords
- stretching, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- AIM 1: Compare HF patients who participate in a home-delivered tablet-based HF health education and gentle stretching intervention, to a health education (HE) group on: a) HF symptoms (weight gain, breathlessness, fatigue), b) psychological symptoms (depression, diminished QOL, resilience, self-care, and heart rate variability), c) physical function (endurance, strength, balance), and d) health care utilization rates (ED visits, office visits, hospitalizations).
- Hypothesis 1: HF symptoms (weight gain, breathlessness, fatigue), psychological symptoms (depression, diminished QOL, resilience, self-care), physical function (endurance, strength, balance) will improve in the intervention group.
- Hypothesis 2: Health care utilization rates (ED visits, office visits, hospitalizations) will decrease in the intervention group.
Secondary:
- AIM 2: Acceptability - Acceptability of the intervention will be determined using: a) participation and satisfaction rates (participant logs), b) intervention retention rates, and c) barriers to participation (technology and participant motivation issues).
- Hypothesis: Subjects in the intervention group will have >80% participation and satisfaction rates and be willing to identify barriers to participation. acceptability of the intervention for future refinement and large scale testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Control Group | No intervention | –Education provided for optional use |
| Gentle Stretching and Education | Experimental | Behavioral: Gentle StretchingGentle Stretching for 60 minutes twice weekly |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Heart failure with reduced ejection fraction or Heart failure with preserved ejection fraction as seen by problem list in the EMR, is a patient in the heart failure clinic, or general cardiology clinic.
- ability to read, write and understand English;
- agree to participate and give informed consent;
- 19 years of age and older;
- telephone access;
Key exclusion criteria (15 listed)
- are pregnant and/or breast feeding (self-reported)
- have a history of non-adherence with medications (as described by their provider or medical record);
- have had a hospitalization within the last 3 months for HF;
- have unstable angina; CABG, MI or biventricular pacemaker less than 6 weeks prior;
- have orthopedic impediments to stretching exercise;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentle StretchingAlso: Exercise60 minutes fo gentle stretching twice weekly for 8 weeks | Behavioural | Gentle Stretching and Education |
Primary outcome
Heart Failure Somatic Perception Scale Questionnaire
Time frame: 10 weeks
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.
PROMIS questionnaire
Time frame: 10 weeks
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.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 10 weeks
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.
The Resilience Scale
Time frame: 10 weeks
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.
Self-Care for Heart Failure Index Questionnaire (SCHFI)
Time frame: 10 weeks
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.
Endurance
Time frame: 10 weeks
2 step test - step alternating knees upward for 2 minutes
upper body strength - we will measure bicep strength by the number of hand weight lifts
Time frame: 10 weeks
participants are instructed to perform as many arm curls as possible for 30 seconds
lower body strength - we will measure quadricep strength by the number of times siting and standing in 30 seconds
Time frame: 10 weeks
participants are instructed to sit and then to stand as many times as possible in 30 seconds
balance
Time frame: 10 weeks
stand on 1 leg for as long as possible
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Background: PubMed 26727546Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8.
- Background: PubMed 15916924Zambroski CH, Moser DK, Bhat G, Ziegler C. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005 Sep;4(3):198-206. doi: 10.1016/j.ejcnurse.2005.03.010.
- Background: PubMed 28705314Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
- Background: PubMed 27503067Braun LT, Grady KL, Kutner JS, Adler E, Berlinger N, Boss R, Butler J, Enguidanos S, Friebert S, Gardner TJ, Higgins P, Holloway R, Konig M, Meier D, Morrissey MB, Quest TE, Wiegand DL, Coombs-Lee B, Fitchett G, Gupta C, Roach WH Jr; American Heart Association Advocacy Coordinating Committee. Palliative Care and Cardiovascular Disease and Stroke: A Policy Statement From the American Heart Association/American Stroke Association. Circulation. 2016 Sep 13;134(11):e198-225. doi: 10.1161/CIR.0000000000000438. Epub 2016 Aug 8.
- Background: PubMed 24815499Dracup K, Moser DK, Pelter MM, Nesbitt TS, Southard J, Paul SM, Robinson S, Cooper LS. Randomized, controlled trial to improve self-care in patients with heart failure living in rural areas. Circulation. 2014 Jul 15;130(3):256-64. doi: 10.1161/CIRCULATIONAHA.113.003542. Epub 2014 May 9.
- Background: PubMed 28654302Donesky D, Selman L, McDermott K, Citron T, Howie-Esquivel J. Evaluation of the Feasibility of a Home-Based TeleYoga Intervention in Participants with Both Chronic Obstructive Pulmonary Disease and Heart Failure. J Altern Complement Med. 2017 Sep;23(9):713-721. doi: 10.1089/acm.2015.0279. Epub 2017 Jun 27.
- Background: PubMed 16204405Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Background: PubMed 10625273Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 2000 Jan 8;320(7227):114-6. doi: 10.1136/bmj.320.7227.114. No abstract available.
- BackgroundMartyn Hammersley. Challenging Relativism: The Problem of Assessment Criteria. Qual Inq. 2009 Jan 1;15(1):3-29.
- BackgroundClive Seale. Quality in Qualitative Research. Qual Inq. 1999 Dec 1;5(4):465-78
- Individual participant dataSharing planned: Yes. Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Stretching in people with Heart Failure, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Somatic Perception Scale Questionnaire (time frame: 10 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120857, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.