Back to resultsExercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction
Primary Purpose
Heart Failure New York Heart Association (NYHA) Class II, Heart Failure New York Heart Association (NYHA) Class III
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Supervised Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure New York Heart Association (NYHA) Class II
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
Sites / Locations
- Skåne University Hospital Lund
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Supervised exercise
Standard of Care
Arm Description
The exercise intervention will include 2 supervised sessions of ergometer cycling with a warm up period of 10 minutes and 20 minutes of cycling at the aerobic intensity below the anaerobic threshold as determined from baseline results. Patients in the exercise arm will have 1 unsupervised exercise session where the participants walk or bicycle for 30 minutes at an intensity experienced as somewhat hard (Borg 13) according to the Borg Rating of Perceived Exertion Scale.
The control group will receive advise to continue to live as usual. After 4 and 8 weeks, participants in the control group will be contacted by telephone for inquiry of general wellbeing. No other interventions will be performed in the control group.
Outcomes
Primary Outcome Measures
Maximal oxygen uptake (VO2peak)
a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg
Secondary Outcome Measures
Health related quality of life
Change in Health related quality of life assessed with Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Cardiac volumes and function
Change in cardiac volumes and function assessed using Cardiac MR indicating effects of the exercise intervention as compared to the control group
Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)
Change in pulmonary congestion quantified by V/P SPECT
Mitochondrial function
Change in mitochondrial number and function using respirometry indicating effects of the exercise intervention as compared to the control group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05255172
Brief Title
Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction
Official Title
Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure New York Heart Association (NYHA) Class II, Heart Failure New York Heart Association (NYHA) Class III
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised exercise
Arm Type
Experimental
Arm Description
The exercise intervention will include 2 supervised sessions of ergometer cycling with a warm up period of 10 minutes and 20 minutes of cycling at the aerobic intensity below the anaerobic threshold as determined from baseline results. Patients in the exercise arm will have 1 unsupervised exercise session where the participants walk or bicycle for 30 minutes at an intensity experienced as somewhat hard (Borg 13) according to the Borg Rating of Perceived Exertion Scale.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The control group will receive advise to continue to live as usual. After 4 and 8 weeks, participants in the control group will be contacted by telephone for inquiry of general wellbeing. No other interventions will be performed in the control group.
Intervention Type
Other
Intervention Name(s)
Supervised Exercise
Intervention Description
12 weeks of supervised aerobic exercise individually adapted to exercise capacity according to a VO2 peak test
Primary Outcome Measure Information:
Title
Maximal oxygen uptake (VO2peak)
Description
a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg
Time Frame
12 weeks intervention
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Change in Health related quality of life assessed with Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time Frame
12 weeks intervention
Title
Cardiac volumes and function
Description
Change in cardiac volumes and function assessed using Cardiac MR indicating effects of the exercise intervention as compared to the control group
Time Frame
12 weeks intervention
Title
Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)
Description
Change in pulmonary congestion quantified by V/P SPECT
Time Frame
12 weeks intervention
Title
Mitochondrial function
Description
Change in mitochondrial number and function using respirometry indicating effects of the exercise intervention as compared to the control group
Time Frame
12 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Skåne University Hospital Lund
City
Lund
ZIP/Postal Code
22158
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction
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