Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
23/09/2014
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 James Nolan

ORCID ID

Contact details

North Staffordshire Hospital NHS Trust
Cardiothoracic Centre
Hartshill
Stoke-on-Trent
ST4 6QG
United Kingdom
+44 (0)1782 552 493
nolanjim@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

895/WRD/38/032

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to compare the relative effectiveness of a conventional aerobic training intervention and a newly developed exercise rehabilitation intervention in improving cardiac autonomic function, exercise capacity and quality of life in patients with chronic heart failure (CHF).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Cardiovascular diseases: heart disease

Intervention

1. Conventional aerobic training intervention
2. A newly-developed exercise rehabilitation

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Cardiac Autonomic Function (heart rate variability)
2. Exercise/functional capacity (VO2 peak)
3. Quality of life (Chronic heart failure Quality of Life Assessment scale, Edinburgh Rehabilitation Scale)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2001

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with chronic heart failure

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2001

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Staffordshire Hospital NHS Trust
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive West Midlands (UK)

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