Health TrialsbyHealthPanel

Neuromuscular Fatigability in Individuals With Heart Failure

ConditionHeart Failure With Reduced Ejection Fraction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorNewcastle University

About this trial

Brief summary

The aims of this project are to 1) characterise muscle fatigue in individuals with chronic heart failure during exercise involving a smaller and larger muscle mass (Part I), 2) to determine the effect of nitrate supplementation on muscle fatigue during large muscle mass exercise in individuals with chronic heart failure (Part II), 3) understand the impact of exercise intolerance on quality of life in individuals with chronic heart failure (Part III). The main questions it aims to answer are:

* Is muscle fatigue attenuated during exercise engaging a smaller vs larger muscle mass in individuals with chronic heart failure owing to lower central cardiopulmonary constraints? * Can supplementation with nitrate-rich beetroot juice reduce muscle fatigue and/or accelerate post-exercise recovery of muscle function in response to whole body exercise in individuals with heart failure? * What impact does exercise intolerance have on the lives of individuals with chronic heart failure?

For Part I, researchers will compare muscle fatigue during single- and double-leg incremental cycling in individuals with chronic heart failure.

For Part II, researchers will compare muscle fatigue in individuals with chronic heart failure during double-leg incremental cycling following a period of beetroot juice supplementation containing nitrate, or with a placebo drink consisting of beetroot juice with nitrate extracted.

For Part III, semi-structured interviews will be conducted to investigate the symptoms associated with performing physical activity and on the impact of exercise intolerance on quality of life in individuals with chronic heart failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a left ventricular ejection fraction < 40% who have been diagnosed for at least 3 months.

Classified according to New York Heart Association (NYHA) class II-III.

Clinically stable and receiving optimal medical treatment.

Aged ≥ 45 years old.

Disqualifiers

An electrically implanted device (e.g., pacemaker, left ventricular assist device).

Uncontrolled cardiac arrhythmias, myocardial infarction, percutaneous coronary intervention and/or bypass graft surgery up to 3 months previously.

Receiving antacids or proton pump, xanthine oxidase, or phosphodiesterase inhibitors which affect the reduction of nitrate to nitrite and nitrite to nitric oxide.

Treated with organic nitrates (e.g., trinitroglycerin)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Nitrate-rich beetroot juice

    Dietary supplement

    Participants will consume 2 x 70 ml bottles of nitrate-rich beetroot juice for a 7 day period prior to exercise testing

  • Beetroot juice with nitrate extracted

    Dietary supplement

    Participants will consume 2 x 70 ml bottles of beetroot juice with nitrate extracted for a 7 day period prior to exercise testing

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Nitrate-rich beetroot juiceExperimental treatment 1 intervention
Group B: Beetroot juice with nitrate extractedPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal voluntary contraction force

Maximal voluntary contraction (MVC) force of the right knee extensor will be taken pre, during and post-exercise.

Time frame
3 years

Secondary outcomes

1

Voluntary activation

Voluntary activation (%) will be measured using supramaximal femoral nerve stimulation during maximal voluntary contractions at pre, during and post-exercise.

Time frame
3 years
2

Resting evoked twitch force

Resting evoked twitch force (Newtons) will be measured using supramaximal femoral nerve stimulation following maximal voluntary contractions at pre, during and post-exercise.

Time frame
3 years
3

Electromyography

Electromyography (root mean squared) of vastus lateralis measured throughout exercise

Time frame
3 years
4

Time constant for recovery of muscle oxygen uptake

Non-invasive measure of skeletal muscle oxidative capacity measured using NIRS-derived time constant for recovery of muscle oxygen uptake

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Newcastle University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: