An interventional study of Exercise in Cardiac Disease and Risk Factor, Cardiovascular, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Prevention
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Among 47 studies in Heart Diseases with a site in Brazil — 10 open to participants now, 12 under way, 3 of them phase 3. Heart Diseases · Brazil.
Among the 47 studies in Heart Diseases with a site in Brazil, this one is the 34th largest by enrollment of the 43 interventional ones that give a count, is one of 3 that started in 2017, is one of 21 with no phase, and was the 23rd registered.
2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.
Browse Heart Diseases studies →10 of the 47 studies in Heart Diseases with a site in Brazil are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Brazil, Argentina, Australia and 35 more countries
Ages 50+
Lexeo Therapeutics · Sites in Brazil, United States, Canada and 5 more countries
Ages 6+
Abbott Medical Devices · Sites in Brazil, France, Germany and 6 more countries
Ages 18+
Eidos Therapeutics, a BridgeBio company · Sites in Brazil, United States, Argentina and 21 more countries
Ages 18–75
University of Sao Paulo · Sites in Brazil
Ages 22+
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 181 Heart Diseases studies recruiting now, 128 (71%) set no upper age limit and 21 (12%) stop at 75 or younger; 32 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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47 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 68 is below the median of 129 across 931 interventional studies indexed under Heart Diseases.
Median enrollment 280 across the 43 interventional studies, 297 across the 4 observational. Of the 28 that completed or were terminated, 13 (46%) have results posted.
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16 of 47 have an industry lead sponsor. The 10 most frequent:
Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.
Universidade Estadual Paulista Júlio de Mesquita Filho has 1 study filed under Heart Diseases — fewer than ten, so there is no comparison to draw.
2 of the studies in Heart Diseases with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07217392Abbott Medical DevicesLeft Bundle Branch Area Pacing (LBBAP) PMCF Study | 2027-04-30 |
| NCT06865482Lexeo TherapeuticsClinical Course Of Disease In Participants With FA-CM | 2027-09 |
Add all 2 to your calendar (.ics) → With an account.
Among the 47 studies in Heart Diseases with a site in Brazil, from their registry updates:
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The aim of this study is to investigate engagement, motivation, and the barriers to adherence of virtual reality based therapy (VRBT) in patients with cardiac diseases and risk factors to the development of cardiac diseases. In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT). To do this, patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT. They will be submitted to an initial evaluation, and then will be random allocated to 12 weeks of intervention and to a final evaluation. The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks using questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program. Hemodynamic and autonomic responses will be considered the secondary outcomes being evaluated before, during and after a session at the first, sixth and twelfth week.
Introduction: cardiovascular rehabilitation programs (CR) can promote several benefits in patients with cardiac diseases. However, there are problems related to the patient adherence in CR. Some of these problems can be caused to factors like motivation. Alternative therapies can improve motivation and increase adherence to CR. In this context, virtual reality based therapy (VRBT), have shown benefits in cardiac patients to pain relief, functional capacity and increasing physical activity levels, but there is no answer whether it can increase engagement and adherence to CR. In addition, it is important to investigate hemodynamic responses of VRBT. Objective: investigate engagement, motivation, and the barriers to adherence of VRBT in patients with cardiac diseases and risk factors to the development of cardiac diseases. In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT). Methods: patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT. They will be submitted to an initial evaluation, the intervention and to a final evaluation. The initial evaluation include eligibility investigation, and after they will be random allocated to the interventions. The interventions will be performed with a frequency of three times a week, for 12 weeks, and the intensity will be prescribed individually. The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks according to a recall questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program. The engagement will be evaluated using the User Engagement Scale (modified). Motivation will be evaluated using the intrinsic motivation questionnaire. The barriers will be evaluated using the Barriers Scale of Cardiac Rehabilitation. Adherence will be evaluated using the presence in the patient's records. Hemodynamic responses will be evaluated before, during and after a session at the first, sixth and twelfth week using blood pressure, heart rate, respiratory rate, oxygen saturation and rating of perceived exertion. Autonomic responses will be evaluated using heart rate variability. Statistical analysis: the data analysis will be evaluated using the two way ANOVA with Bonferroni posttest with significance to p \< 0.05.
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Exclusion Criteria:
Exercise-based cardiac rehabilitation
Other: Exercise
Exercise-based virtual reality
Other: Exercise
Both interventions uses exercises
Engagement
Measured using the Utrecht engagement scale modified There is 17 items scored from 1 to 7, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a better engagement.
Time frame: Change from baseline at 12 weeks
Motivation
Measured using the Intrinsic motivation inventory There is 18 items scored from 1 to 5, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a better motivation.
Time frame: Change from baseline at 12 weeks
Barriers to Cardiac Rehabilitation
Measured using Cardiac Rehabilitation Barriers Scale There is 21 items score from 1 to 5, according to the Likert Scale. Then, each item is summed and divided for the number of items. Higher values represent a worse outcome. In addition, there is four subscales: 1) Perceived need/health care factors, 2) Logistical factors, 3) Work/time conflicts, and 4) Comorbidities/functional status. The subscales are scored in the same way of the total, it means, from 1 to 5 and them dividing from the total number of the items included in the subscale.
Time frame: Change from baseline at 12 weeks
Adherence to Cardiac Rehabilitation
Measured using the number of cardiac rehabilitation sessions attended
Time frame: Change from baseline at 12 weeks
Autonomic responses
Measured using heart rate variability The heart rate variability will be measured through the following linear indices (SDNN: the standard deviation of normal-to-normal intervals, ms; rMSSD: the root mean square of successive difference between normal intervals,ms; RRtri: triangular index, based on RR intervals,ms; TINN: triangular interpolation of the normal to normal interval between consecutive heart beats, ms; LF: low frequency, nu; HF: high frequency and nonlinear indices,nu.). In addition the nonlinear indices will be measured (SD1: standard deviation of instant variability beat to beat; SD2: standard deviation of long-term interval between consecutive heart beats). In general higher values represent a better autonomic response.
Time frame: Up to 12 weeks
Blood pressure
Measured using both systolic blood pressure and diastolic blood pressure
Time frame: Up to 12 weeks
Heart rate
Measured using an equipment validated for recording heart rate beat to beat
Time frame: Up to 12 weeks
Respiratory rate
Measured using the number of respiratory incursions in one minute
Time frame: Up to 12 weeks
Oxygen Saturation
Measured using an oximeter
Time frame: Up to 12 weeks
Perceived exertion
Measured using Borg Scale. This scale varies from 6 to 20.
Time frame: Up to 12 weeks
Plan to share: No — After published results,
Ran from Dec 2017 to primary completion in Dec 2018, 11 months.
Of 263 non-industry interventional studies with no phase under Heart Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's 11 months is below that.
Counting every sponsor, half of 336 studies reached it within 25 months; a quarter within 10 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Universidade Estadual Paulista Júlio de Mesquita Filho