NCT02732990

Brief Summary

Exercise intolerance is a major limiting symptom in patients with CHF. However the poor correlation between the hemodynamic parameters of left ventricular performance at rest and exercise performance has led to the concept that peripheral factors such as muscle perfusion and muscle metabolism play a role as determinants of exercise capacity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2014

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

November 6, 2014

Last Update Submit

April 4, 2016

Conditions

Chronic Heart Failure

Keywords

TrainingOne-legged exercisePeripheral blood flowCardiac functionMuscle metaboreflex

Outcome Measures

Primary Outcomes (1)

  • Change from baseline sympathetic nerve activity after 6 weeks of training

    Sympathetic nerve activity, measured in plasma and dialysat with reference to nor-adrenaline.

    6 weeks

Secondary Outcomes (3)

  • The effect of exercise training on exercise capacity in regards to oxygen uptake

    6 weeks

  • The effect of exercise training on exercise capacity in regards to maximal workload

    6 weeks

  • The effect of exercise training on exercise capacity in regards to a 6 min walk test

    6 weeks

Study Arms (4)

Exercise training - Whole body exercise

EXPERIMENTAL

Control subjects will train 2-legged cycling (whole body exercise) for 6 weeks

Behavioral: Exercise training

Exercise training - One-legged exercise

EXPERIMENTAL

Control subjects will train high intense one-legged exercise for 6 weeks

Behavioral: Exercise training

Exercise training - 2-legged cycling CHF

EXPERIMENTAL

CHF patients will train 2-legged cycling (whole body exercise) for 6 weeks

Behavioral: Exercise training

Exercise training - CHF

EXPERIMENTAL

CHF Patients will train high intense one-legged exercise for 6 weeks

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)

Exercise training - 2-legged cycling CHFExercise training - CHFExercise training - One-legged exerciseExercise training - Whole body exercise

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New York Heart Association (NYHA) Class II - III
  • Ejection fraction \<35%
  • Heart failure as a result of previous myocardial infarction
  • Optimal treatment (ACE-inhibitors, beta-blockers)
  • Stable heart failure
  • Patients with and without implantable cardioverter defibrillator (ICD)

You may not qualify if:

  • Peripheral vascular disease with symptoms of atherosclerosis (intermittent claudication)
  • Aneurysm in a. femoral
  • Moderate to severe heart valve disease
  • Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 \<60%
  • Heart Failure Patients with Biventricular pacemaker (BVP)
  • Serious heart rhythm disturbances (arrhythmias such as atrial fibrillation and frequent premature ventricular contractions)
  • Myocardial infarction within the last month
  • Unstable angina (angina pectoris)
  • Renal failure (creatinine greater than 2.5 mg / dL)
  • Severe systemic disease of the nervous system, pulmonary or other severe organ involvement
  • BMI\> 30
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Inflammation and Metabolism (CIM), Centre for Physical Activity Research

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stefan P Mortensen, Dr. Med

    IMM - Department of Cardiovascular and Renal Research

    STUDY CHAIR

Central Study Contacts

Gregers W Munch, MSc PhD

CONTACT

+45 35459574gregers.munch@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CIM administrator

Study Record Dates

First Submitted

November 6, 2014

First Posted

April 11, 2016

Study Start

February 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

DK(1)