NCT02575469

Brief Summary

Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g. ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way to measure exercise capacity is to perform a cardiopulmonary exercise testing. Normal/reference values in health and disease relate to specific population and subpopulations. The population in Israel is unique in its diversity. Objectives: Data collection of exercise capacity assessment in health and illness in the northern of Israel for future local database. Population: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls. Study design: Prospective observational study. Participants will answer a health related questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a treadmill or a cycle ergometer.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress47%
Oct 2017Jan 2036

First Submitted

Initial submission to the registry

October 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2035

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2036

Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

18 years

First QC Date

October 12, 2015

Last Update Submit

January 23, 2017

Conditions

Exercise Capacity

Outcome Measures

Primary Outcomes (1)

  • VO2 (oxygen consumption)

    30 minutes

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls.

You may qualify if:

  • Ability to complete full exercise evaluation (including cardiopulmonary exercise testing).

You may not qualify if:

  • Acute illness on visit day.
  • for healthy volunteers: chronic disease or use of medications.
  • Professional athletes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM health care center

Haifa, 31096, Israel

Location

Central Study Contacts

Abraham Lorber, MD

CONTACT

+972-4-7774630a_lorber@rambam.health.gov.il

Ronen Bar-Yoseph, MD

CONTACT

+972-4-777-4304ronenfabi@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of pediatric cardiology institute, Ruth children hospital

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 14, 2015

Study Start

October 1, 2017

Primary Completion (Estimated)

October 1, 2035

Study Completion (Estimated)

January 1, 2036

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

IL(1)