NCT02000479

Brief Summary

The purpose of this study is to investigate the effects of a combined training programme on insulin resistance, exercise tolerance, muscle strength, body composition and cardiac function in chronic heart failure patients. It is assumed that the above mentioned clinical parameters will improve due to physical exercise.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

2 months

First QC Date

November 27, 2013

Last Update Submit

December 8, 2013

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity (insulin profile)

    glucose and insulin concentration measurements in blood during oral glucose tolerance test

    change from baseline to 12 weeks

Secondary Outcomes (6)

  • Exercise tolerance

    change from baseline to 12 weeks

  • HbA1c, blood lipids, BNP

    change from baseline to 12 weeks

  • Muscle strength

    change from baseline to 12 weeks

  • Body composition

    change from baseline to 12 weeks

  • cardiac function

    change from baseline to 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

training

EXPERIMENTAL

12 weeks (2 x 6 weeks) of combined exercise training programme (supervised)

Other: training

Control

NO INTERVENTION

Continued usual care, habitual lifestyle

Interventions

trainingOTHER
Also known as: 12 weeks of combined exercise training
training

Eligibility Criteria

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

You may qualify if:

  • diagnosis of chronic heart failure for at least 6 months
  • clinically stable (not hospitalized) for more than 3 months prior to the onset of the study
  • optimal medical therapy.

You may not qualify if:

  • any contra-indication for exercise therapy,
  • glucose lowering medical therapy,
  • active lifestyle with regular physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • An Stevens, dra.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

April 1, 2011

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

December 10, 2013

Record last verified: 2013-12