NCT00214513

Brief Summary

The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

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

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 17, 2007

Status Verified

May 1, 2007

First QC Date

September 16, 2005

Last Update Submit

May 16, 2007

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.

Secondary Outcomes (9)

  • Secondary endpoints:

  • Maximum oxygen uptake at 14 months

  • Maximum exercise capacity measured by the Shuttle Walk test at 14 months

  • Exercise capacity measured by 6-minute walking test (6MWT)at 14 months

  • Muscular strength (sit-to-stand) at 14 months

  • +4 more secondary outcomes

Interventions

Home-based exercise trainingBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA II-IV
  • Ejection Fraction ≤45% assessed by echocardiography within the last 6 months
  • Optimal medical treatment according to guidelines
  • Informed consent -

You may not qualify if:

  • Hæmodynamically significant obstructive heart valve disease
  • Hæmodynamically significant valve insufficiency
  • Recent Myocardial infarction (8 weeks)
  • Significant arrythmia at exercise testing (NSVT, VT, VF or SVT with ventricular action \>150)
  • Significant ischaemia or angina at low strain(£ 50 W)
  • Disabilities that render physical training impossible
  • Dementia
  • Serious other illness with expected shortened survival
  • Participation in other scientific protocols that do not allow participation
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amager Hospital

Copenhagen, 2300 S, Denmark

Location

Related Publications (1)

  • Prescott E, Hjardem-Hansen R, Dela F, Orkild B, Teisner AS, Nielsen H. Effects of a 14-month low-cost maintenance training program in patients with chronic systolic heart failure: a randomized study. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):430-7. doi: 10.1097/HJR.0b013e32831e94f8.

    PMID: 19491687DERIVED

Study Officials

  • Eva Prescott, MD

    Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Study Completion

July 1, 2006

Last Updated

May 17, 2007

Record last verified: 2007-05

Locations

DK(1)