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临床试验/NCT06481657
NCT06481657已完成不适用

The Effect of Oxygen Supplementation in Training in Heart Failure Patients on Aerobic Performance and Quality of Life

Laniado Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
disease severity

研究概览

简要总结

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.

详细描述

The study population: The study recruited 24 patients with heart failure who came to the cardiac rehabilitation program at Laniado Hospital who met the inclusion criteria. After receiving an explanation of the study, the participants were asked to sign an informed consent form and were randomly divided into 2 training groups, with and without oxygen administration. A sample, using G-power software, medium effect size (0.3), power 0.8 and an error of 0.05 was found to be equal to 24 participants.

Measurement and evaluation tool:

Maximum effort protocol: to assess the maximum aerobic capacity, a graded exercise test was performed on a moving track according to the Bruce protocol. which began by walking at 2.4 km/h and a 10% incline, every three minutes the incline and speed were increased until the subject reported that he/she could not continue any longer. At the end of each step the heart rate was recorded Heart rate and the subjective degree of difficulty according to the Borg scale. The last stage reached by the subject was used to determine multiple values (calculated heart rate and maximum oxygen consumption).

Aerobic submaximal exercise protocol: the test consisted of walking on a track at an incline and speed determined according to the phase corresponding to the Bruce protocol in which the patient reached 80% of the maximum heart rate at the beginning of the training program, the participant was asked to persist in walking until he could not continue at the required pace and reached fatigue. Record the time and distance until the end of the effort.

A submaximal exercise protocol to compare single exercise conditions with and without oxygen: In order to compare the effect of supplementing oxygen in a single exercise some of the participants (n=20) performed a submaximal exercise protocol with and without oxygen in two consecutive sessions and in random order. The tests were performed on a rail at an incline and speed determined according to the phase corresponding to the Bruce protocol in which the patient reached 80% of the heart rate. In the test under oxygen conditions, oxygen supplementation of ~20% (5 liters per minute) was given using oxygen goggles, and in the test under conditions without oxygen supplementation (placebo) room air was given (5 liters per minute) using oxygen goggles. Every three minutes, the heart rate was recorded, the feeling of exertion and the level of lactic acid in the blood, the time and distance that the participants gulped until they reported that they could not continue with the given effort was recorded. The tests were done within 72 hours and in random order.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

The experimental group will train with oxygen goggles in the aerobic part of the training The control group will train with oxygen goggles without oxygen enrichment (placebo).

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Patients with heart failure with EF (ejection fraction) <50% - according to echocardiography in an effort performed in the community.
  • Women and men in the 18-90 age range.

排除标准

  • Patients who are prevented from engaging in physical activity for any reason.
  • patients who are unable to walk due to orthopedic or neurological limitations.
  • patients with a disturbance in the electrical conduction at rest or exertion, which prevents them from exerting themselves.
  • patients with a decrease in Oxygen saturation below 95%..
  • children, who have no judgment, helpless patients and pregnant women will also not be included in this study.

结局指标

主要结局

disease severity

时间窗: the test will be tested before the start of the training program and immediately thereafter

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

aerobic training indices

时间窗: the test will be tested before the start of the training program and immediately thereafter

six minute walk test

Quality of life and disease severity

时间窗: the test will be tested before the start of the training program and immediately thereafter

Quality of life will be measured using The Kansas City Cardiomyopathy Questionnaire

maximall aerobic training indices

时间窗: the test will be tested before the start of the training program and immediately thereafter

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

submaximal aerobic training indices

时间窗: the test will be tested before the start of the training program and immediately thereafter

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.

次要结局

  • 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.(the test will be tested before the start of the training program)

研究者

发起方
Laniado Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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