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Assessment of Exercise Intensity in Cardiac Rehabilitation Programmes for Patients With Chronic Heart Failure

6 maart 2012 bijgewerkt door: Guy Lloyd

Cardiac rehabilitation is the ideal comprehensive intervention for patients with chronic heart failure (CHF), since it addresses the complex interplay of medical, psychological and behavioural factors facing these individuals. Structured exercise training within a cardiac rehabilitation programme is firmly recommended for these patients. However, it is questionable whether patients are achieving an adequate dose of exercise to provide optimal benefits. The essential components for setting optimal training include the appropriate mode, duration, frequency and intensity of exercise. UK surveys of cardiac rehabilitation describe the frequency and duration of training, but here is scant information on exercise intensity. However, it is apparent that randomised controlled trials of exercise training use doses more than 4 times greater than in UK current practice. The Eastbourne Exercise Cardiology Research Group has demonstrated that although patients benefit from improved quality of life and submaximal fitness after a hospital outpatient cardiac rehabilitation programme, they do not achieve the increases in important prognostic indicators reported by the majority of exercise training trials.

The critical factor in terms of eliciting a sufficient training effect while minimising risk is the intensity of the exercise performed. It is now widely accepted that the traditional methods of using fixed percentages of maximal heart rate or oxygen uptake to set exercise intensity include serious errors. The European Society of Cardiology recommends that cardiopulmonary exercise testing should be used to provide an objective evaluation of the metabolic demand of exercise. This allows physiologically meaningful reference points to be established for aerobic exercise prescription and is the solution to defining safe and effective training intensities. The next step is to determine whether this information can be transferred to a practical cardiac rehabilitation environment to set and monitor exercise intensity

Studie Overzicht

Toestand

Onbekend

Conditie

Hartfalen

Gedetailleerde beschrijving

Background Heart failure is a chronic, costly and life-threatening disorder that constitutes a significant burden for individuals and the National Health Service [There are 27,000 new cases reported per annum in the UK. Cardiac rehabilitation (CR) is recommended as the ideal comprehensive intervention since it addresses the complex interplay of medical, psychological and behavioural factors facing CHF patients and carers.

Study Aim Primary objective to describe the exercise intensity, defined by oxygen uptake (VO2) in terms of the individual physiological thresholds, in CHF patients undergoing CR according to current guidelines Primary end point: VO2 Secondary objectives Secondary objectives of this study are:-

To measure resting and exercising energy expenditure in order to a) establish the value of 1 MET (resting metabolic rate) for patients with CHF, and b) to establish the MET value (defined as multiples of resting metabolic rate) for exercises performed in CR sessions
To measure affective responses (feeling very bad - feeling very good; levels of energy - tiredness and tension - calmness) to exercise during CR sessions
To measure weekly physical activity level in CHF patients undergoing Phase III and IV CR.

For the secondary analysis the following secondary end points and parameters will be established

MET values, defined as multiples of resting oxygen uptake or resting metabolic rate (1 MET), for different CR exercises
Ratings of affective response on the Feelings Scale (FS) and ratings of perceived activation on the Felt Arousal Scale (FAS).
Average daily activity over 7 day period in terms of steps per day and periods spent sitting, standing and walking

Studietype

Observationeel

Inschrijving (Verwacht)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigd Koninkrijk
- East Sussex
  - Eastbourne, East Sussex, Verenigd Koninkrijk, BN21 2UD
    - Eastbourne General Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

21 CHF patients from Heart Failure clinic at Eastbourne District General Hospital

Beschrijving

Inclusion criteria:

Systolic heart failure with resting left ventricular ejection fraction below 40%
New York Heart Association (NYHA) class I-III
clinically stable for at least 4 weeks on optimised medication dosage according to current guidelines

Exclusion criteria:

Acute coronary syndrome within past 6 months
Untreated lifethreatening cardiac arrhythmias
Acute heart failure (during initial period of haemodynamic instability)
Uncontrolled hypertension
Advanced atrioventricular block
Acute myocarditis or pericarditis
Symptomatic aortic stenosis
Severe hypertrophic obstructive cardiomyopathy
Acute systemic illness Intracardiac thrombus
Progressive worsening of exercise tolerance of dyspnoea at rest over previous 35 days
Significant ischaemia during low intensity exercise (< 2 METS, < 50W)
Uncontrolled diabetes
Recent embolism
Thrombophlebitis
New onset atrial fibrillation/flutter
> 1.8 kg increase in body mass over previous 13 days
Concurrent, continuous or intermittent dobutamine therapy
Decrease in systolic blood pressure with exercise
NYHA Functional Class IV
Complex ventricular arrhythmia at rest or appearing with exertion
Supine resting heart rate > 100 beats/min
Patient is participating in a conflicting study, is unable to perform exercise testing
Patient lacks the capacity to consent or cannot comply with study requirements

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
The primary outcome measure is the oxygen uptake(VO2)during exercise Tijdsspanne: 13 weeks	13 weeks

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Affective responses (e.g. feelings of pleasure/displeasure) Tijdsspanne: 13 weeks	Questionnaire used to measure affective responses (Feelings Scale, Felt Anxiety Scale and Activation/Deactivation )	13 weeks
Weekly physical activity Tijdsspanne: 13 weeks	Average daily physical activity: Participants' freeliving activity will be classified by ActivPAL into periods spent sitting, standing and walking, and daily energy expenditure will also be estimated from this information.	13 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Guy Lloyd

Onderzoekers

Hoofdonderzoeker: Guy W Lloyd, MD, Eastbourne General Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2012

Primaire voltooiing (Verwacht)

1 april 2013

Studie voltooiing (Verwacht)