The Effect of Oxygen Supplementation in Training in Heart Failure Patients on Aerobic Performance and Quality of Life
NCT Number: NCT06481657
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure With Reduced Ejection Fraction|Heart Failure With Mid Range Ejection Fraction
Interventions: OTHER: train with oxygen and without oxygen enrichment (placebo).
Sponsor: Laniado Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2022-02-10
Completion Date: 2023-08-20
Locations: Laniado Hospital, Netanya, Israel

Summary:
Background: Physical training in patients with heart failure has been proven to reduce mortality and hospitalization rates, but many have difficulty performing an effort due to a lack of oxygen supply to the muscle and its fatigue. The effect of supplementing oxygen in a single effort was found to improve the level of oxygen reaching the muscle, the duration and intensity of the effort.

The effect of supplemental oxygen during an exercise program in heart failure patients on exercise performance has not yet been examined.

The aims of the study: 1. To test the effect of a training program with oxygen supplementation, on maximal and submaximal aerobic exercise, six-minute walk (6MWT) and quality of life in patients with heart failure. 2. Testing the effect of oxygen supplementation in a single effort on the lactate concentration and performance of the effort.

Methods: 24 independent heart failure patients, without a decrease in saturation, with an ejection fraction \<50% were recruited for the study and were randomly divided into two groups, a training group with supplemental oxygen (O2) and a control group that trained without supplemental oxygen. Before and after a training program that lasted two months, the following were tested: maximal aerobic power, submaximal aerobic exercise time, 6MWT, disease severity according to the New York Heart Association - NYHA and quality of life according to the Kansas Questionnaire (KCCQ)). In addition, a single submaximal effort was performed at 80% of maximum heart rate with and without oxygen supplementation. Every 3 minutes the lactate concentration, heart rate and the difficulty of the effort were measured. To test the effect of the intervention on the outcome measures, a 2way ANOVA test was performed for repeated measurements.

Importance of the study: The results of the study will make it possible to examine for the first time the effect and importance of oxygen supplementation during training in cardiac rehabilitation settings. On aerobic training indices and quality of life.

Primary Outcome Measures: maximall aerobic training indices, Maximum aerobic power will be tested before the start of the training program and immediately thereafter by a maximum rated stress test according to Proctol Bruce, the test will be tested before the start of the training program and immediately thereafter|submaximal aerobic training indices, Sub-maximal aerobic exertion: The assessment will include walking to fatigue on a sloping track and speed according to the Bruce Proctol phase where the patient was at 80% of the maximum heart rate in a pre-workout rated stress test., the test will be tested before the start of the training program and immediately thereafter|aerobic training indices, six minute walk test, the test will be tested before the start of the training program and immediately thereafter|Quality of life and disease severity, Quality of life will be measured using The Kansas City Cardiomyopathy Questionnaire, the test will be tested before the start of the training program and immediately thereafter|disease severity, New York Heart Association-NYHA - A measure of the severity of the disease that includes 4 different levels: Level 1, which represents a condition in which there is impaired heart function but the patient is short of breath when performing level 4 exercise, when the patient is unable to exercise without shortness of breath. Even at rest, the test will be tested before the start of the training program and immediately thereafter
Secondary Outcome Measures: Examination of the involvement of the anaerobic system by measuring the concentration of lactic acid (HH) in a single submaximal effort with and without the addition of oxygen., Lactic acid level - will be measured by a capillary blood test during two sub-maximal tests which will include walking to fatigue on a sloping track and speed according to the Bruce Proctol phase where the patient was at 80% of the maximum heart rate in the rated stress test. Every 3 minutes and at the end of the test. One test will be performed with oxygen and one without oxygen., the test will be tested before the start of the training program