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

NCT01545102 | Unknown

• 1 other identifier: TN11-26
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Failure

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the oxygen uptake(VO2)during exercise

  13 weeks

Secondary Outcomes (2)

• Affective responses (e.g. feelings of pleasure/displeasure)

  13 weeks

• Weekly physical activity

  13 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy Lloyd: lead

Study Sites (1)

Eastbourne General Hospital

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Guy W Lloyd, MD

  Eastbourne General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jet van Zalen, MSc, BSc

CONTACT

01323417400; jet.vanzalen@esht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

GB (1)