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临床试验/NCT04592718
NCT04592718已完成不适用

The Effects of Four-week Breathing Interventions on Gastrointestinal Symptoms, Heart Rate Variability, and Psychological Measures in Runners

Old Dominion University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Change in gastrointestinal symptom occurrence

研究概览

简要总结

Recent research has suggested that stress and anxiety levels are associated with gastrointestinal (GI) symptoms in endurance athletes (runners, cyclists, triathletes). Yet, there has been limited attempt to evaluate whether GI symptoms during running can be mitigated by interventions designed to reduce stress and anxiety. Thus, this study will evaluate the effects of four-week slow deep breathing and mindful breath counting interventions on subjective and objective measures of stress/anxiety and GI symptoms in runners with mild-to-high anxiety and that are prone to GI symptoms during runs.

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
None

入排标准

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

入选标准

  • •At least 18 years of age
  • •Run at least 15 miles per week
  • •Access to internet
  • •Access to a smart phone that is compatible with iOS or Android applications
  • •Score at least a 5 on the GAD-7
  • •Report to have experienced GI symptoms "sometimes", "often" or "always" during runs in the previous month.
  • •If on a psychotropic medication, must be on a stable dose for the past 3 months.
  • •Live within the contiguous United States

排除标准

  • •Younger than 18 years
  • •Run less than 15 miles per week
  • •Do not have access to the internet
  • •Do not have access to a smart phone that is compatible with iOS or Android applications
  • •Score less than 5 on the GAD-7
  • •Report to have "never" or "rarely" experienced GI symptoms during runs in the previous month
  • •Are being prescribed a psychotropic medication and have not had a stable dose for at least three months.
  • •Do not live within the contiguous United States

研究组 & 干预措施

Slow deep breathing plus breath counting

Experimental

Participants in this group will do a daily 5-min slow deep breathing exercise (6 breaths/minute) and will also count their breaths

干预措施: Slow deep breathing plus breath counting (Behavioral)

Normal-paced breathing plus breath counting

Active Comparator

Participants in this group will do a daily 5-min normal-paced breathing (15 breaths/minute) and will also count their breaths

干预措施: Normal-paced breathing plus breath counting (Behavioral)

Control

No Intervention

Participants in this group will serve as a control and will not do any breathing exercises or breath counting.

结局指标

主要结局

Change in gastrointestinal symptom occurrence

时间窗: The intervention will last 4 weeks. Gastrointestinal symptoms will be collected for a 1-week period before the intervention and during the 4th week of the intervention.

Percentage of training runs that runners experience at least 1 gastrointestinal symptom (\>2 on 0-10 scale).

Change in anxiety levels

时间窗: The intervention will last 4 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.

Levels of anxiety will be assessed with the General Anxiety Disorder-7 questionnaire. Scores on the General Anxiety Disorder-7 range from 0 to 21, with higher scores indicating higher levels of anxiety.

次要结局

  • Change in visceral sensitivity(The intervention will last 4 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.)
  • Change in mindfulness(The intervention will last 4 weeks. The Five Facet Mindfulness Questionnaire will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.)
  • Change in body vigilance(The intervention will last 4 weeks. The Body Vigilance Scale will be assessed before the intervention begins, 2 weeks into the intervention, and at the end of the intervention.)
  • Change in heart rate variability (Ln RMSSD)(The intervention will last 4 weeks. Ln RMSSD will be assessed before the intervention begins, and at the end of the intervention.)

研究者

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

Patrick Wilson, PhD

Associate Professor of Exercise Science

Old Dominion University

研究点 (1)

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