Is Threshold-based Training Superior in Cardiac Rehabilitation

NCT04114929 | Withdrawn

• 1 other identifier: UCentalLancashire
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates two methods of prescribing exercise intensity in a Phase IV cardiac rehabilitation programme. One method is using specific ventilatory markers and the other following standard care guidelines.

Conditions

Cardiac Rehabilitation

Keywords

ventilatory anaerobic threshold; Intensity; Exercise Dose; Standard care

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen Consumption Change

  Peak Oxygen Consumption as determined by a cardiopulmonary exercise test

  Baseline & 3 months

Secondary Outcomes (1)

• Health Related Quality of Life Change (EuroQoL EQ-5D)

  Baseline & 3 months

Study Arms (2)

Threshold-Based

EXPERIMENTAL

Patients will be prescribed exercise based on ventilatory thresholds from a maximal cardiopulmonary exercise test

Other: Threshold-based Training

Standard Care

ACTIVE COMPARATOR

Patients will be prescribed exercise based on standard guidelines

Other: Standard Care

Interventions

Threshold-based Training OTHER

Specific ventilatory markers determined from a cardiopulmonary test and the correlating heart rate will be used to determine exercise intensity

Threshold-Based

Standard Care OTHER

Using the standard care cardiac rehabilitation guidelines exercise will be based on estimated heart rate maximum followed by the karvonan method to calculate 40-70% heart rate reserve

Standard Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has read and understood the Patient Information Sheet
• Diagnosis of coronary heart disease (CHD) including myocardial infarction(MI), coronary artery bypass graft (CABG) surgery, elective percutaneous coronary intervention (PCI) or exertional angina.
• Diagnosis of heart failure
• Aged between 18 and 85 years
• Absence of contraindications to exercise testing and training
• Clinically stable (symptoms and medication)
• Patient is able to and has given written informed consent
• Able to comply with guidelines for participation in exercise testing \& prescription

You may not qualify if:

• Clinically Unstable

Sponsors & Collaborators

• University of Central Lancashire: lead
• University of Hull: collaborator
• Leeds Beckett University: collaborator
• Sheffield Hallam University: collaborator

Study Sites (1)

School of Sport and and Health Sciences

Preston, United Kingdom

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer In Exercise Science

Model Details: Patients will randomised either to threshold-based training or standard care

Study Record Dates

• First Submitted: September 28, 2019
• First Posted: October 3, 2019
• Study Start: March 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: August 1, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

GB (1)