跳至主要内容
临床试验/NCT07103291
NCT07103291招募中不适用

The Effects of Isocapnic Respiratory Muscle Endurance Training on the Multidimensional Components and Neurophysiological Mechanisms of Exertional Breathlessness in Healthy Adults

University of British Columbia2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
2
主要终点
Change from baseline in dyspnoea ratings on the 0-10 Borg scale after respiratory endurance training

研究概览

简要总结

Respiratory muscle training (RMT) strengthens breathing muscles and may improve exercise performance and reduce breathlessness. However, different training methods and devices create controversy in the field. Two main types of RMT exist: inspiratory muscle training (IMT) and respiratory endurance training, like voluntary isocapnic hyperpnea (VIH). While IMT is well-studied, the impact of VIH on breathlessness remains unclear. This study will use the Canadian-developed BreathWayBetter device to examine how 5 weeks of VIH affects breathing discomfort and muscle function. Findings may help personalize RMT for athletes and clinical patients, improving respiratory care and exercise tolerance.

详细描述

Purpose: to determine the effect of voluntary isocapnic hyperpnea (VIH) respiratory muscle training (RMT) using the BreathWayBetter training device on the multidimensional components of dyspnoea, as well as exercise performances measures.

Objectives and Hypothesis:

Objective 1: The first primary objective is to examine the effects of the BreathWayBetter (BWB) training device on the intensity and unpleasantness of dyspnoea during exercise, and to determine what sensory qualities of dyspnoea are primarily affected.

Hypothesis 1: Change in dyspnea intensity (pre vs post training) will be the same in the sham and training group, however, the reduction in dyspnea unpleasantness will be significantly greater in the training group. The training group will also have a greater reduction in breathlessness-related emotional ratings compared to the sham group.

Objective 2: The second primary objective is to examine the effects of the BreathWayBetter (BWB) training device on peak oxygen consumption (VO2peak) during the pre and post intervention incremental cycle exercise tests in both conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-55 years of age (inclusive)
  • Male or Female (biological sex)
  • Body mass index greater than 18 or less than 30 kg/m2
  • Normal pulmonary function: FEV1/FVC > 0.70 and FEV1 ≥ 80%
  • Able to read and understand English
  • Regularly trains and/or competes at a regional, national, or international level as a road cyclist or triathlete
  • Access to a device with the capability to download the Isocapnic app (Apple IOS or Google Play/Android) or the ability to use the Web Based application.

排除标准

  • Currently smoke, vape, or use cannabis, or have a history of frequent smoking, vaping or cannabis use
  • History of, or current symptoms of cardiopulmonary (i.e., lung and/or heart) disease (excluding controlled asthma)
  • Heart problem; a serious infection within the body; a neuromuscular (nerve to muscle) or musculoskeletal (muscle, ligament and/or bone) disorder; or other health problem that will be made worse with exercise testing
  • Contraindications to exercise testing defined as anything that would prevent exercise under proper and safe conditions (e.g. a problem with the heart or lungs, muscle or bone injury, a serious infection)
  • Currently pregnant
  • Required to read and understand English due to the nature of the consent form and study materials, including questionnaires and training instructions, which are only available in English.

研究组 & 干预措施

Progressive high frequency and intensity training

Active Comparator

Participant will perform a respiratory training following a progressive intensity and frequency protocol

干预措施: Respiratory muscle endurance training (Other)

Low frequency and intensity training

Sham Comparator

Participant will perform a respiratory training following a low intensity and frequency protocol

干预措施: Sham respiratory muscle endurance training (Other)

结局指标

主要结局

Change from baseline in dyspnoea ratings on the 0-10 Borg scale after respiratory endurance training

时间窗: Up to 7 weeks

Dyspnoea ratings on the 0-10 Borg scale will be recorded during and after incremental cardiopulmonary exercise testing on a stationary cycle ergometer. Dyspnoea ratings will then be compared between the pre- and post-intervention visits.

Difference in maximal oxygen consumption (VO2peak) following high intensity training program compared to sham comparator program.

时间窗: Up to 7 weeks

Changes in peak oxygen consumption (VO2peak) will be measured during an incremental cardiopulmonary exercise test on a stationary cycle ergometer and compared between intervention conditions.

次要结局

  • Correlation between changes from baseline in maximal oxygen consumption (VO2peak) and changes from baseline in dyspnoea ratings on the 0-10 Borg scale following respiratory endurance training.(Up to 7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan Guenette

Professor

University of British Columbia

研究点 (2)

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