CClinicalTrials.gg
Status unknownNCT01567189CERC1Updated Mar 30, 2012

Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation

An interventional study of Cardiac rehabilitation and Cardiac rehabilitation in Coronary Heart Disease, sponsored by Basque Health Service. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-30.

Sponsored by Basque Health Service · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The hypothesis is that home based clinical rehabilitation (CR) is less expensive than hospital based CR with similar clinical effectiveness. The investigators will compare the results of two forms of CR on

  1. direct and indirect healthcare costs
  2. effectiveness on mortality, morbidity, modifiable risk factors control, functional capacity measured by exercise testing, health related quality of life and satisfaction rate
  3. cost/effectiveness analysis
Read the detailed description

The main reasons for patients not to participate in a cardiac rehabilitation program that usually develops by group in the hospital or in a gym, are problems of access to hospital, disgust for participating in a group activity and problems in reconciling their work and / or home with the program schedule. These problems could be overcome by outcome cardiac rehabilitation and thus could increase the number of patients benefit from treatment in either the environment extra or intra-hospital.

Low and medium coronary patients sent to cardiac rehabilitation program at our center within the first 12 weeks after presenting with acute coronary syndrome or been revascularized will be included in the study. The prescription of intensity of effort is based on heart rate reached during the stress test for the initial evaluation in all cases, although at home-program heart rate will be monitored using heart rate monitor and / or by the Borg scale. In this way outpatient group patient could performed training sessions individually and at the time of day that best suits their capabilities. The other program components: control of risk factors, health education and counseling will be identical in both groups of patients.

02

Conditions studied

  • Coronary Heart Disease

Keywords

  • Exercise therapy
  • cost effectiveness
  • cardiac rehabilitation
  • home-based exercise
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 138 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Basque Health Service is the lead sponsor of 55 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients referred to cardiac rehabilitation program in the first twelve weeks after an acute coronary syndrome (myocardial infarction or unstable angina) or after percutaneous or surgical revascularization
  • who have no contraindication to participate in the program

Exclusion criteria

Exclusion Criteria:

  • contraindication to participate in the program
  • high-risk criteria for home cardiac rehabilitation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants (estimated)

Study arms

  • Experimental
    Hospital cardiac rehabilitation

    The patients will perform physical training sessions in the hospital

    Behavioral: Cardiac rehabilitation

  • Active comparator
    Home cardiac rehabilitation

    The patients will perform physical training sessions at home

    Behavioral: Cardiac rehabilitation

Interventions

  • BehavioralCardiac rehabilitation

    * Training sessions: 8 weeks of supervised physical training sessions. Stress intensity will be calculated from the peak heart rate reached during stress test: 60-70% during the first month and 70-85% during the second one. Patients will be advised to do at least 1 hour of outdoor exercise with the same intensity on the days when they do not attend hospital. * Health education sessions and relaxation sessions: one per week. * Smoking and diet checking: as recommended by doctor.

  • BehavioralCardiac rehabilitation

    The only difference in the hospital's program is that training sessions will be out of hospital with the same target heart rate that in this case will be controlled with pulsometer or Borg scale. The recommended frequency of sessions will be: at least 5 days a week with a minimum of 1 hour / day.

06

What researchers measure

Primary outcomes

  1. Morbidity

    Readmissions, percutaneous or surgical revascularization

    Time frame: 1 year

  2. Cost

    1. Direct costs 1. direct healthcare costs: hospital admissions for cardiovascular causes, percutaneous or surgical revascularization, medical and nursing consultation, physical training sessions, medical explorations including the analytic explorations, medication consumption, emergency department visits, depreciation of equipment used. 2. Direct costs other than health: Transfer the patient for his attention, passenger costs if necessary. 2. Indirect costs: working days lost during program participation (2 months, family overloads caused by participation in the program (2 months).

    Time frame: 1 year

Secondary outcomes

  1. Control of risk factors

    Control of risk factors at the end of training sessions and one year after the acute event: Percentage of patients achieving the therapeutic goal outlined in the clinical practice guidelines in each of the risk factors

    Time frame: 1 year

  2. Functional capacity

    Oxygen consumption peak measured during exercise testing

    Time frame: 1 year

  3. Quality of Life

    SF-12 version 2

    Time frame: 1 year

  4. Satisfaction

    satisfaction questionnaire based on Osakidetza Basque Health Service questionnaires

    Time frame: 1 year

  5. Mortality

    All cause mortality

    Time frame: 1 year

07

Study locations

1 site
  • Araba University Hospital
    Vitoria, Álava 01009, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01567189
Lead sponsor
Basque Health Service
Responsible party
Fernando Arós Borau (Cardiologist, Basque Health Service) — Principal investigator
First posted
Mar 30, 2012
Start date
Apr 2012
Primary completion
Apr 2013 (estimated)
Completion
Apr 2013 (estimated)
Last update
Mar 30, 2012

Study contacts

Fernando Aros Borau
Contact
LUISFDO.AROSBORAU@osakidetza.net
+34 945 007000

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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