Fatigue Clinical Trial
Official title:
Testing the Effects of Qigong on a Multi-System Neuro-muscular- Immune Model of Vigor in Cancer Survivorship
This study compares Qigong movement-based meditation exercise with a healthy living
exercise-wellness course. There are two primary goals of this research:
1. Evaluate and compare physiological mechanisms underlying the two wellness-exercise
interventions with the specific goal of understanding the physiology of Qigong.
Using a simple noninvasive EEG setup, the study will test some of the same brain
mechanisms that have been found in mindfulness meditation.
The study will also investigate Qigong's effects on stress and heart signals and on
inflammation in the immune system. A key hypothesis is that Qigong will show
distinctive, stronger effects on brain and heart measures. A related hypothesis is that
Qigong will show stronger effects on blood markers of inflammation.
2. Compare effect sizes of the two interventions in decreasing fatigue in order to plan
for a larger clinical trial.
Between 20-50% of Cancer Survivors report fatigue following treatment that interferes with
their daily life. However, to date no treatment option has been definitively validated as
effective for fatigue in survivors. In recent years Mind Body exercises such as yoga, Tai
Chi, and Qigong have been shown in small clinical trials to be effective at treating the
symptoms of CRF in a wide array of Cancer types. But understanding of basic science
mechanisms is poor.
Recent studies of Mindfulness meditation, by the investigators and others, confirm the
importance of brain mechanisms related to awareness and attention. This study will assess
whether Qigong activates similar physiological processes. The study will also assess (1)
whether emotion regulation improves, suggesting that Mindfulness-related processes may
partially underlie changes in Qigong as a Mindful exercise (2) whether grip strength
improves, suggesting that Qigong activates similar processes to conventional exercise.
As an exploratory question, the study will look at whether brain measures related to
awareness are correlated with inflammatory markers called cytokines, suggesting possible
neuro-immune interaction that may be relevant for understanding fatigue, vitality and
embodied meditative movement therapies such as Qigong, Tai Chi and Yoga.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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