Technological Platforms and Telerehabilitation in Heart Surgery

NCT02653326 | Completed Results

• 1 other identifier: CEC093-15
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cardiovascular Diseases; Cardiac Surgery

Keywords

Tertiary Prevention; Telerehabilitation

Outcome Measures

Primary Outcomes (2)

• Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation

  Ergospirometric assessment of oxygen consumption (VO2) among study participants.

  4 weeks after randomisation

• Exercise Capacity

  Exercise Capacity Assessed as Peak Oxygen Consumption at 8 weeks after randomisation

  8 weeks after randomisation

Secondary Outcomes (2)

• Number of Participants With Adverse Events at 4 Weeks

  4 weeks after randomisation

• Number of Participants With Adverse Events at 8 Weeks

  8 weeks after randomisation

Study Arms (2)

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.

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.

Procedure: Physical Therapy; Behavioral: Nutritional Counseling; Other: Depression Screening; Drug: Treatment of Comorbidities

Interventions

Telerehabilitation Monitors DEVICE

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.

Telerehabilitation

Physical Therapy PROCEDURE

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.

Routine Care; Telerehabilitation

Nutritional Counseling BEHAVIORAL

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.

Routine Care; Telerehabilitation

Depression Screening OTHER

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.

Routine Care; Telerehabilitation

Treatment of Comorbidities DRUG

Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.

Routine Care; Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years old)
• Recent cardiac surgery (3 weeks)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• Hospital Dr. Gustavo Fricke: collaborator
• Fundación Dr. Jorge Kaplan Meier: collaborator

Study Sites (2)

Fundacion Cardiovascular Dr. Jorge Kaplan Meier

Viña del Mar, Región de Valparaíso, Chile

Location

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Physical Therapy Modalities; Nutrition Assessment

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Carla Taramasco
• Organization: Universidad de Valparaiso

carla.taramasco@uv.cl

2508306

Study Officials

• Carla Taramasco, Ph.D.

  Universidad de Valparaiso

  STUDY DIRECTOR

• Felipe T Martinez, M.D., M.Sc

  Universidad de Valparaiso

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)