Symptoms and General Pathology

All Conditions

Inflammation

Fatigue

This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include guided instruction in the theory and background of qigong and healing. Practice will include gentle stretching and guided qigong movement as well as seated and lying down meditations. Participants will be asked to complete about 30 minutes a day of home assignments.

This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) as well as core-stretching, strengthening, and light aerobic movements through a Pre-Train exercise program. Participants will be asked to complete about 30 minutes a day of home assignments.

Qigong is a form of gentle mind-body movement that originates in China and has traditionally been used for healing purposes. It has been reported to improve energy levels, as well as strength and endurance and mental clarity and equanimity. This study will assess how a 10-week qigong intervention compares to an exercise-nutrition intervention in improving fatigue and vitality in female cancer survivors. On a secondary level, we will asses changes in underlying brain, heart, and peripheral dynamics that occur as a result of the qigong practice to develop a mechanistic understanding of qigong's efficacy.

Qigong

The Healthy Living active comparator intervention includes two components: plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) and core strengthening exercises and light aerobic activity via the Pre-Train exercise program.

Healthy Living (CHIP + Pre-Train)

Chloe S Zimmerman, BA

Ellen Flynn, MD

Susan Martin, LDN, IBCLC

This parallel, randomized, non-inferiority trial will examine whether a ten week qigong intervention is not inferior to a ten week exercise-nutrition comparison group in reducing fatigue in cancer survivors. To build a more mechanistic understanding of physiological changes associated with fatigue reduction, it will secondly collect several different types of data to build an integrative brain-body model of vigor in cancer survivorship including:

1. data related to neural correlates of body awareness: cortical EEG data measuring each subject's ability to use attention to control neurons in primary somatosensory cortex (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures of insular connectivity with nodes of the default mode network and salience network
2. data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6 and tnf-alpha)
3. data related to cardiorespiratory functioning including cardiac impedance (ICG) and mechanical lung function
4. data related to parasympathetic and sympathetic signaling between the nervous system and the rest of the periphery.

The purpose of this study is to examine the therapeutic effects of movement and body awareness on recovery from cancer-related fatigue. In the current study, 60-80 female cancer survivors with cancer-related fatigue will be recruited who have been out of treatment for at least eight weeks. They will be randomized to either a 10-week qigong contemplative movement course or a 10 -week exercise-nutrition course. This study is designed as a non-inferiority trial to test the primary hypothesis that a ten week qigong intervention is not inferior to a ten week exercise-nutrition active comparator group in reducing fatigue in female cancer survivors (assessed via the FACIT-Fatigue scale). If non-inferiority is demonstrated during analysis, the data will be further analyzed to examine whether the qigong group significantly decreases fatigue more than the healthy living comparison group. The FACIT-Fatigue scale will be delivered at three time points: before the intervention starts (T1), after it ends (T2), and three months after the intervention has ended (T3). Further, this study will directly examine the underlying physiological mechanisms by which each intervention exerts its effects. Participants will be tested pre (T1) and post (T2) intervention on a variety of measures across multiple bodily and brain systems (eg EEG, fMRI, EMG, ECG, ICG, mechanical lung function, Doppler flowmetry, serum cytokines, muscle strength, 6 min walk test) to assess changes in these systems that are associated with reduction of fatigue and improvement of the subjective sense of vitality and energy. The data will be used to test whether conscious attention to bodily sensations cultivated in contemplative movement practices (i.e. Qigong) can actually impact levels of inflammation in the periphery as well as cortical measures of interoceptive awareness (ie resting state insula connectivity), and whether these changes will be associated with fatigue reduction. The secondary hypothesis is that decreased inflammation levels in the blood will be correlated with reduction in fatigue at post intervention as well as changes in neural markers of interoceptive and bodily awareness, and that this effect will be stronger in the qigong group.

This parallel, randomized non-inferiority trial will test whether qigong is not inferior to an exercise/nutrition active comparator group in terms of reducing fatigue in female cancer survivors. If non-inferiority is demonstrated during analysis, a secondary analysis will test whether qigong can be considered superior to the exercise-nutrition comparator

Participants will not find out what interventional group they are placed in (qigong vs. healthy living) until after they have completed their first testing session.

Pre intervention data collection and post intervention data analysis will be completely masked.

The Vitality Project for Fatigued Female Cancer Survivors

Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors

Apple watches will be supplied to interested participants to monitor their heart rate and physical steps taken throughout the day to assess changes in movement patterns while participating in the classes

To assess changes in self-reported stress

A measure of a person's tendency to care for other's before themselves

Measure of how much a person has been excising or relaxing

Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire

Will be measured to calculate heart rate variability (HRV)

Will be used to assess exercise related improvements in cardiovascular tone.

Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms)

A task that involves subtle taps to the finger tips, EEG is simultaneously recorded to examine modulation in brain rhythms across somatosensory cortex related to cued attention to the tap

A measure of one's ability to hold a lever at a steady force, EEG and EMG simultaneously record corticomuscular coherence that may facilitate steady grip

Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments

to determine the impact of exercise and movement on overall lung function

To measure the interaction between the brain measures of bodily awareness and the immune system

Optional measure: To assess changes in functional connectivity associated with participation in the intervention

Assessed via jamar hand dynamometers and back, leg, and arm dynamometers to assess changes in muscle tone associated with the classes

Test of how far a participant can walk in six minutes to assess overall endurance

Measure of physical, social, emotional, and functional well-being

Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions)

To assess fatigue, vigor, and overall mood

Measurement of sleep quality, habits, and patterns

Measures multiple factors of emotional dysregulation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Vitality Project for Fatigued Female Cancer Survivors	NCT03259438	Fatigue Cancer Survivor...	Qigong Healthy Living ...	18 Years - 70 Years	The Miriam Hospital
The Vitality Project for Fatigued Female Cancer Survivors	NCT03259438	Fatigue Cancer Survivor...	Qigong Healthy Living ...	18 Years - 70 Years	The Miriam Hospital
The Vitality Project for Fatigued Female Cancer Survivors	NCT03259438	Fatigue Cancer Survivor...	Qigong Healthy Living ...	18 Years - 70 Years	The Miriam Hospital

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