Recruiting

Qigong

Sponsor:

The Miriam Hospital

Code:

NCT02845492

Conditions

Fatigue

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Qigong

Complete Health Improvement Program (CHIP)

Study Details

Brief summary:

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.

Conditions

Fatigue

Study ID

NCT02845492

Start date

Jul, 2016

Status verified date

Jul, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female patients
  • Aged 18-70 years
  • Self-report of fatigue =/> 3/10 on fatigue interference scale
  • Have been diagnosed and completed treatment for cancer (with surgery or radiation or chemotherapy)
  • no surgery, radiation or chemotherapy received in the past 8 weeks (ongoing treatment with Herceptin \[trastuzumab\] or other adjuvant therapies is permitted)
  • Currently cancer-free
  • Have a primary care or other physician
  • Ability to understand English
  • Willingness to have blood drawn, have an EEG taken and complete questionnaires
  • Ability to pass basic validated physical movement tests (e.g.: standing with feet touching for 30 seconds, twist right to left and back, hold arms out to side in air for 15 seconds, lift arms over head, moving from standing position to seated position on the floor) to verify safety for Qigong practice.

Exclusion Criteria:

  • History or current diagnosis of medical or psychiatric disorder that would interfere with ability to participate in wellness classes or in scientific assessment sessions (e.g., rheumatoid arthritis, diabetes, major psychiatric disorder, connective tissue disorder)
  • Body Mass Index (BMI) > 31
  • Active alcohol or drug abuse
  • Tobacco use
  • Pregnancy
  • Regular daily use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs, (does not apply to common use of daily "baby aspirin" as daily prophylactic cardiovascular treatment)
  • Resting systolic blood pressure of less than 90 or greater than 160 and resting diastolic blood pressure of greater than 110.
  • Ingestion of caffeine or cocoa products less than two hours from data collection
  • Contraindication to regular physical activity participation
  • Already engaging in >60 min of vigorous physical activity per week for the prior month
  • Weekly practice of yoga, Tai Chi, Qigong, or meditation since the diagnosis of cancer
  • Peripheral neuropathy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Qigong intervention

Qigong meditative exercise intervention meets three times a week for 10 weeks. The qigong group (n=30) will meet at the Women's Medicine Collaborative, Miriam Hospital (146 W. River St., Providence, RI) for Qigong classes. The lesson will be taught by a validated Qi Gong master with over forty years of experience and the interventional protocol will be validated. Two and a half hours of weekly outside personal practice will also be required of participants.

active comparator: CHIP healthy wellness-exercise class

The Complete Health Improvement Program is a validated set of weekly classes designed to promote gentle exercise and wellness related activities in a supportive group setting led by an experienced trainer.

Interventions

Qigong

Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations

Complete Health Improvement Program (CHIP)

The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.

Primary outcome measure

  • Fatigue Symptom Inventory Questionnaire [ Time Frame: Change from baseline to 10 weeks ]

Central Contacts and Locations

Central contacts

Chloe Zimmerman, BA

4018636272chloe_zimmerman@brown.edu

Brendan Cullen, BA

4018636272Brendan_Cullen@brown.edu

Locations

Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

Chloe Zimmerman

401-863-6272cancersurvivor@lifespan.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Aug 1, 2016

Last verified

Jul, 2016

Keywords

  • Exercise
  • Qigong
  • Mind-Body
  • Fatigue
  • Cancer
  • EEG
  • HRV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2016-08-01.