Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supervised Exercise.
- Who it may be relevant to
- Registry conditions: Heart Failure New York Heart Association (NYHA) Class II, Heart Failure New York Heart Association (NYHA) Class III. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities
Overview
The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.
Detailed description
A randomized, non-blinded prospective intervention trial. Patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. Before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac MR) examinations, Ventilation/Perfusion Single Photon Emission Computed Tomography (V/P SPECT), Cardiopulmonary exercise tests, muscle biopsies and blood sampling.
Interventions
- Other Supervised Exercise
12 weeks of supervised aerobic exercise individually adapted to exercise capacity according to a VO2 peak test
Primary outcome measures
- Maximal oxygen uptake (VO2peak) [Time frame: 12 weeks intervention]
Secondary outcome measures (4)
- Health related quality of life [Time frame: 12 weeks intervention]
- Cardiac volumes and function [Time frame: 12 weeks intervention]
- Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT) [Time frame: 12 weeks intervention]
- Mitochondrial function [Time frame: 12 weeks intervention]
Eligibility criteria
Inclusion criteria
- Signs and symptoms of heart failure
- Age ≥50 years
- Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
- Able to understand and follow exercise prescription
- Currently physically inactive (less than 150 minutes/week moderate intensity exercise)
Exclusion criteria
- Currently or within the past 6 months been involved in cardiac rehab with exercise
- Devices or implants not compatible with magnetic resonance imaging or exercise testing
- Any orthopedic or medical condition affecting participation in testing and training
- Signs of acute ischemia during baseline cardiopulmonary exercise testing
- Participation in other clinical trials that may affect results
- Moderate or severe valvular disease
- Atrial fibrillation
- Moderate or severe chronic obstructive pulmonary disease
- NYHA class IV
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Skåne University Hospital Lund — Lund
Identifiers
NCT: NCT05255172 · 2021-05044