NCT00146315

Brief Summary

In Spain, family physician are currently recommended to prescribe an unsupervised walking program to their coronary heart disease (CHD) patients as a part of their cardiac rehabilitation program. However, there are a few family physicians who provide their CHD patients with supervised exercise (30 minutes of pedaling on an stationary bicycle at 60-85% of the peak heart rate (HR) attained at the maximal or symptom limited treadmill test, 3 times a week) at their primary care health centers, thinking that these patients improve their functional capacity, quality of life, and the control of cardiovascular risk factors, more than walking because they can not achieve the ideal exercise intensity for maximal benefits by walking. This study has been designed to investigate if CHD patients get more health benefits with the supervised exercise program at the health center than with the unsupervised walking program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

5.4 years

First QC Date

September 6, 2005

Last Update Submit

May 31, 2011

Conditions

Coronary Heart Disease

Keywords

Primary Health CareFamily PracticeFamily PhysicianExerciseCoronary Heart DiseaseRandomized Controlled TrialsMulticenter Studies

Outcome Measures

Primary Outcomes (1)

  • Functional capacity (exercise treadmill test)

    6 months follow-up

Secondary Outcomes (2)

  • Health Related Quality of life (SF-36)

    6 months follow-up

  • Cardiovascular risk factor control

    6 months follow-up

Study Arms (2)

Control

ACTIVE COMPARATOR

Secondary prevention program for coronary heart disease

Behavioral: Secondary prevention program for coronary heart disease

Supervised exercise

EXPERIMENTAL
Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week

Interventions

Supervised exercise on a stationary bicycle, 3-5 days a weekBEHAVIORAL

Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease

Supervised exercise
Secondary prevention program for coronary heart diseaseBEHAVIORAL

Secondary prevention program for coronary heart disease

Control

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary heart disease low risk patients
  • Under 80 years old

You may not qualify if:

  • years of age and over
  • Patients included in cardiac rehabilitation programs
  • Moderate and high risk patients
  • Patients with handicaps for exercising
  • Patients unable to attend the supervised exercise sessions
  • Unstable angina
  • Uncontrolled atrial ventricular arrhythmias
  • Third degree AV block (without pacemaker)
  • Uncompensated congestive heart failure
  • Severe aortic stenosis
  • Suspected or known dissecting aneurysm
  • Active myocarditis or pericarditis
  • Thrombophlebitis
  • Recent embolism
  • Acute systemic illness or fever
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Primary Care Research Unit of Bizkaia (Basque Health Service)

Bilbao, Bizkaia, 48014, Spain

Location

Santa Barbara primary care center (Castilla La Mancha Health Service)

Toledo, Toledo, 45007, Spain

Location

Related Publications (2)

  • Ortega Sanchez-Pinilla R. [Differences in intensity of effort between supervised and non-supervised exercise of patients with ischaemic cardiopathy]. Aten Primaria. 2004 Sep 30;34(5):265-6. doi: 10.1016/s0212-6567(04)70847-1. No abstract available. Spanish.

    PMID: 15456577BACKGROUND

  • Ortega R, Garcia-Ortiz L, Torcal J, Echevarria P, Vargas-Machuca C, Gomez A, Salcedo F, Lekuona I, Montoya I, Grandes G; ESCAP Group. Supervised exercise for acute coronary patients in primary care: a randomized clinical trial. Fam Pract. 2014 Feb;31(1):20-9. doi: 10.1093/fampra/cmt059. Epub 2013 Oct 19.

    PMID: 24142481DERIVED

MeSH Terms

Conditions

Coronary DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavior

Study Officials

  • Ricardo Ortega, Dr.

    Santa Barbara primary care center (Castilla La Mancha Health Service)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

ES(2)