Condition category
Circulatory System
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
19/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hareld M.C. Kemps

ORCID ID

Contact details

Máxima Medical Centre
Department of Sport Medicine
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 8888620
H.Kemps@wxs.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The time constant of oxygen uptake during recovery of submaximal exercise is a reliable parameter to measure the effects of exercise training in patients with chronic heart failure

Ethics approval

Not provided at time of registration

Study design

Randomised crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Heart failure

Intervention

Exercise training (12 weeks) versus standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change of time constant of oxygen onset or recovery kinetics >10 seconds

Secondary outcome measures

1. Change in peak volume of oxygen (VO2)
2. Quality of life

Overall trial start date

01/09/2002

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Stable chronic heart failure (CHF) (New York Heart Association [NYHA] class II-III and echocardiographical ejection fraction </= 40%) attributed to idiopathic dilated cardiomyopathy or ischemic heart disease due to myocardial infarction

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Myocardial infarction or unstable angina pectoris in previous three months
2. Atrial fbrillation or flutter
3. Chronic obstructive pulmonary disorder (COPD) (Tiffenau index <60%)

Recruitment start date

01/09/2002

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Máxima Medical Centre
Veldhoven
5500 MB
Netherlands

Sponsor information

Organisation

Máxima Medical Center, Department of Sport Medicine (The Netherlands)

Sponsor details

P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

'Friends of the Heart' Foundation (Stichting 'Vrienden van het Hart')

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes