A Novel Home-based Physical Activity Intervention for Stable Chronic Heart Failure Patients

NCT03677271 | Completed

• 2 other identifiers: 7512IRAS project ID: 173307
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The project focuses on heart failure (HF), a complex clinical syndrome of symptoms and signs that suggest the efficiency of the heart as a pump is impaired. Around 950,000 people in the UK have HF. Both the incidence and prevalence of heart failure increase steeply as a result of an ageing population, improved survival of people with ischaemic heart disease and more effective treatments for heart failure. Aside from the obvious individual burden HF also accounts for 1 million inpatient bed days - 2% of all NHS inpatient bed days and 5% of all emergency medical admissions to hospital which are projected to rise by 50% over the next 25 years. There is a pressing need to explore effective ways to manage the individual and societal burden of HF. Despite exercise being an effective, safe, and a recommended (class I) therapy for people with heart failure according to clinical guidelines from the UK, EU, and USA, it is currently out of reach for majority people with HF. This project addresses this directly by designing and evaluating an exercise therapy that will be available to those living with HF with potential to improve their symptoms, function and quality of life

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

• Number of participants with heart failure screened, recruited into and completing the intervention

  Data will be collected on recruitment and retention rates and adherence to intervention and trial procedures. Collated data will be expressed in percentages.

  2 years

Secondary Outcomes (3)

• Quality of Life Score using Minnesota living with heart failure questionnaire

  2 years

• Maximum Oxygen Consumption (ml/Kg/min) Post intervention

  2 years

• Haemodynamic markers (cardiac output, stroke Volume)

  2 years

Study Arms (1)

Physical Activity

OTHER

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

Physical Activity

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>50 years of age) with chronic HF due to reduced ejection fraction
• Clinically stable for at least 6 weeks prior to screening
• Receipt of optimal medical treatment
• Able to walk and perform activities of daily living independently
• New York Heart Association functional class II-IV
• Left ventricular ejection fraction \<40%
• Willingness to undertake a physical activity intervention
• Willingness to visit the clinical research facility on 2 separate occasions

You may not qualify if:

• Severe aortic stenosis
• Severe cardiac arrhythmias
• Myocardial infarction, percutaneous coronary intervention and/or bypass graft surgery over the past 3 months
• Severely obese i.e. body mass index \>40
• Implanted with left ventricular assist device
• Current participation in cardiac rehabilitation programme
• Inability to provide informed consent.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (1)

• Okwose NC, O'Brien N, Charman S, Cassidy S, Brodie D, Bailey K, MacGowan GA, Jakovljevic DG, Avery L. Overcoming barriers to engagement and adherence to a home-based physical activity intervention for patients with heart failure: a qualitative focus group study. BMJ Open. 2020 Sep 21;10(9):e036382. doi: 10.1136/bmjopen-2019-036382.

  PMID: 32958484 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 19, 2018
• Study Start: December 16, 2015
• Primary Completion: December 19, 2016
• Study Completion: December 19, 2016
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share