Cardiovascular DiseasesNCT02653326
Technological Platforms and Telerehabilitation in Heart Surgery
A study testing Telerehabilitation Monitors, Physical Therapy and Nutritional Counseling in people with Cardiovascular Diseases and Cardiac Surgery, run by Universidad de Valparaiso at 2 sites in Chile.
Trial summary
In this randomised, double-blind, pilot study, the investigators aim to assess whether a telerehabilitation strategy could improve outcomes among patients with recent heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Surgery
- What is being tested?
- Telerehabilitation Monitors, Physical Therapy and Nutritional Counseling
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesChile
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years old)
- Recent cardiac surgery (3 weeks)
Who cannot join
- Contraindication to physical exercise (unstable angina, acute heart failure, complex ventricular arrythmias, severe (>60mmHg) pulmonary hypertension, endocavitary thrombuses, recent deep venous thrombosis (1 month), severe obstructive cardiomyopathy, symptomatic aortic stenosis, musculoskeletal conditions that make exercise impossible)
- Parkinsons' Disease
- Severe dementia or major psychiatric comorbidities that make adherence or comprehension of the intervention impossible
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Fundacion Cardiovascular Dr. Jorge Kaplan Meier
Viña del Mar, Valparaiso
Hospital Gustavo Fricke
Viña del Mar, Valparaiso
About this study
Official title: Integrative Technological Platforms for Telerehabilitation for Patients With Heart Surgery: A Pilot Randomised Trial
In this randomised, double-blind, pilot study, the investigators aim to assess whether a telerehabilitation strategy could improve outcomes among patients with recent heart surgery. Included participants will receive a comprehensive rehabilitation programme comprised of physical therapy, nutritional counselling, psychological assistance in addition to standard medical care. After 12 sessions of physical therapy, patients will be randomised to receive telerehabilitation with a portable EKG device and a smartphone application or usual care. The primary endpoint for this study is the exercise capacity of included participants, which will be assessed using an ergospirometer at 4 and 8 weeks after randomisation.
Read the detailed description
As in other Latin-american countries, access to rehabilitation programmes is limited, even though their effectiveness has been proved among patients with heart surgery and endorsed in current practice guidelines. In this randomised trial, the investigators aim to assess whether an integrative technological platform might improve the exercise capacity of patients that have undergone heart surgery.
Eligible patients include adult (>18 years old) patients who have undergone any kind of heart surgery in the Hospital Gustavo Fricke between January and December 2016. Patients will be enrolled within 3 weeks of their cardiac surgery into the trial. Patients with any contraindication to physical exercise (see below), Parkinson's disease, severe dementia or psychiatric comorbidities that preclude the initiation of the programme will be excluded. All patients will receive physical training delivered by a group of physical therapists divided in twelve 90-minute sessions. The overall goal of these sessions will be to obtain a workload of 80% - 90% of maximum oxygen consumption (VO2) as established by ergospirometric assessments (Cardiovit CS-200). In addition to exercise, patients will also receive nutritional support, education, risk factor modification and psychological assessments using the Hospital Anxiety and Depression Scale that has been validated in Spanish-speaking countries.
Randomisation will be performed by a statistician and study personnel will be kept unaware of the specific method used. Patients in the intervention arm will receive a telerehabilitation strategy comprised by a portable EKG device that will be aimed at establishing heart rate, stress responses and recovery times after physical activities. This sensor will be used to monitor compliance with a prescribed physical therapy programme. In addition, a second sensor will be deployed in the form of a smartphone application that will provide alerts for patients and healthcare providers whenever an adverse event is recorded. The application will also provide motivational messages for participants to optimize adherence to the exercise programme, as well as information regarding individual improvements in physical activities.
All patients will undergo an ergospirometry at baseline, 4 weeks and 8 weeks after completion of the initial physical therapy sessions. Clinicians, outcome assessors and analysts well be kept unaware of treatment allocations. All analyses will be undertaken under the intention to treat principle. No prespecified subgroup analyses have been programmed.
- Conditions
- Cardiovascular Diseases, Cardiac Surgery
- Being tested
- Telerehabilitation Monitors, Physical Therapy, Nutritional Counseling, Depression Screening, Treatment of Comorbidities
- Keywords
- Tertiary Prevention, Telerehabilitation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation MonitorsDevice
After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
Physical TherapyProcedure or surgery
Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
Nutritional CounselingBehavioural
Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
Depression ScreeningOther
Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
Treatment of ComorbiditiesDrug
Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | In addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. Receives: Device: Telerehabilitation Monitors; Procedure: Physical Therapy; Behavioral: Nutritional Counseling; Other: Depression Screening; Drug: Treatment of Comorbidities |
| Routine Care | Active comparator | Patients allocated to routine care will receive care as enforced by current practice guidelines. This care included nutritional counseling, depression screening, drug therapy for the management of comorbidities and physical exercise without telemonitoring. Receives: Procedure: Physical Therapy; Behavioral: Nutritional Counseling; Other: Depression Screening; Drug: Treatment of Comorbidities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation
Ergospirometric assessment of oxygen consumption (VO2) among study participants.
Measured: 4 weeks after randomisation
Exercise Capacity
Exercise Capacity Assessed as Peak Oxygen Consumption at 8 weeks after randomisation
Measured: 8 weeks after randomisation
Secondary outcomes (2)
Number of Participants With Adverse Events at 4 Weeks
Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.
Measured: 4 weeks after randomisation
Number of Participants With Adverse Events at 8 Weeks
Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.
Measured: 8 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Dr. Gustavo Fricke, Fundación Dr. Jorge Kaplan Meier
- Responsible party
- Principal investigator, Felipe Martinez, Universidad de Valparaiso
- Investigators
- Carla Taramasco, Ph.D., Study director, Universidad de ValparaisoFelipe T Martinez, M.D., M.Sc, Principal investigator, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653326
- Sponsor's protocol ID
- CEC093-15
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2016
- Last updated
- 28 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Technological Platforms for Telerehabilitation for Patients With Heart Surgery: A Pilot Randomised Trial
- ClinicalTrials.gov ID
- NCT02653326
- Acronym / sponsor ID
- CEC093-15
- Conditions
- Cardiovascular Diseases, Cardiac Surgery
- Keywords
- Tertiary Prevention, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Hospital Dr. Gustavo Fricke, Fundación Dr. Jorge Kaplan Meier
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomised, double-blind, pilot study, the investigators aim to assess whether a telerehabilitation strategy could improve outcomes among patients with recent heart surgery. Included participants will receive a comprehensive rehabilitation programme comprised of physical therapy, nutritional counselling, psychological assistance in addition to standard medical care. After 12 sessions of physical therapy, patients will be randomised to receive telerehabilitation with a portable EKG device and a smartphone application or usual care. The primary endpoint for this study is the exercise capacity of included participants, which will be assessed using an ergospirometer at 4 and 8 weeks after randomisation.
Detailed description
As in other Latin-american countries, access to rehabilitation programmes is limited, even though their effectiveness has been proved among patients with heart surgery and endorsed in current practice guidelines. In this randomised trial, the investigators aim to assess whether an integrative technological platform might improve the exercise capacity of patients that have undergone heart surgery.
Eligible patients include adult (>18 years old) patients who have undergone any kind of heart surgery in the Hospital Gustavo Fricke between January and December 2016. Patients will be enrolled within 3 weeks of their cardiac surgery into the trial. Patients with any contraindication to physical exercise (see below), Parkinson's disease, severe dementia or psychiatric comorbidities that preclude the initiation of the programme will be excluded. All patients will receive physical training delivered by a group of physical therapists divided in twelve 90-minute sessions. The overall goal of these sessions will be to obtain a workload of 80% - 90% of maximum oxygen consumption (VO2) as established by ergospirometric assessments (Cardiovit CS-200). In addition to exercise, patients will also receive nutritional support, education, risk factor modification and psychological assessments using the Hospital Anxiety and Depression Scale that has been validated in Spanish-speaking countries.
Randomisation will be performed by a statistician and study personnel will be kept unaware of the specific method used. Patients in the intervention arm will receive a telerehabilitation strategy comprised by a portable EKG device that will be aimed at establishing heart rate, stress responses and recovery times after physical activities. This sensor will be used to monitor compliance with a prescribed physical therapy programme. In addition, a second sensor will be deployed in the form of a smartphone application that will provide alerts for patients and healthcare providers whenever an adverse event is recorded. The application will also provide motivational messages for participants to optimize adherence to the exercise programme, as well as information regarding individual improvements in physical activities.
All patients will undergo an ergospirometry at baseline, 4 weeks and 8 weeks after completion of the initial physical therapy sessions. Clinicians, outcome assessors and analysts well be kept unaware of treatment allocations. All analyses will be undertaken under the intention to treat principle. No prespecified subgroup analyses have been programmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Device: Telerehabilitation Monitors, Procedure: Physical Therapy, Behavioral: Nutritional Counseling, Other: Depression Screening, Drug: Treatment of ComorbiditiesIn addition to routine care, patients in this arm will receive a telerehabilitation strategy comprised by a portable EKG monitor and a smartphone application. |
| Routine Care | Active comparator | Procedure: Physical Therapy, Behavioral: Nutritional Counseling, Other: Depression Screening, Drug: Treatment of ComorbiditiesPatients allocated to routine care will receive care as enforced by current practice guidelines. This care included nutritional counseling, depression screening, drug therapy for the management of comorbidities and physical exercise without telemonitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years old)
- Recent cardiac surgery (3 weeks)
Key exclusion criteria (4 listed)
- Contraindication to physical exercise (unstable angina, acute heart failure, complex ventricular arrythmias, severe (>60mmHg) pulmonary hypertension, endocavitary thrombuses, recent deep venous thrombosis (1 month), severe obstructive cardiomyopathy, symptomatic aortic stenosis, musculoskeletal conditions that make exercise impossible)
- Parkinsons' Disease
- Severe dementia or major psychiatric comorbidities that make adherence or comprehension of the intervention impossible
- Refusal to participate
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 |
|---|---|---|
| Telerehabilitation MonitorsAfter completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment. | Device | Telerehabilitation |
| Physical TherapyPhysical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant. | Procedure or surgery | Routine Care, Telerehabilitation |
| Nutritional CounselingNutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification. | Behavioural | Routine Care, Telerehabilitation |
| Depression ScreeningParticipants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician. | Other | Routine Care, Telerehabilitation |
| Treatment of ComorbiditiesWhenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants. | Drug | Routine Care, Telerehabilitation |
Primary outcome
Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation
Time frame: 4 weeks after randomisation
Ergospirometric assessment of oxygen consumption (VO2) among study participants.
Exercise Capacity
Time frame: 8 weeks after randomisation
Exercise Capacity Assessed as Peak Oxygen Consumption at 8 weeks after randomisation
2 secondary outcomes
Number of Participants With Adverse Events at 4 Weeks
Time frame: 4 weeks after randomisation
Number of Participants With Adverse Events at 8 Weeks
Time frame: 8 weeks after randomisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Carla Taramasco, Ph.D. study director
Universidad de Valparaiso
Felipe T Martinez, M.D., M.Sc principal investigator
Universidad de Valparaiso
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Monitors, Physical Therapy and Nutritional Counseling in people with Cardiovascular Diseases and Cardiac Surgery, run by Universidad de Valparaiso at 2 sites in Chile.
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 2 inclusion and 4 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 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation (time frame: 4 weeks after randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2019.