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Qigong for Post Acute Sequelae of COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05675995
Recruitment Status : Recruiting
First Posted : January 9, 2023
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Michelle Dossett, University of California, Davis

Tracking Information
First Submitted Date  ICMJE January 4, 2023
First Posted Date  ICMJE January 9, 2023
Last Update Posted Date January 9, 2023
Actual Study Start Date  ICMJE January 4, 2023
Estimated Primary Completion Date January 24, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2023)		 Change in physical health [ Time Frame: 8 weeks ]
Change in PROMIS-29 physical health summary score from before to after intervention in all participants
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Qigong for Post Acute Sequelae of COVID-19 Infection
Official Title  ICMJE Qigong for Post Acute Sequelae of COVID-19 Infection
Brief Summary The purpose of this study is to conduct a pilot feasibility study of external qigong on health-related quality of life in individuals with prolonged symptoms following COVID-19 infection.
Detailed Description

The purpose of this study is to determine whether external qigong, a traditional Chinese medicine healing practice, improves quality of life and symptoms for individuals with prolonged symptoms following a COVID-19 infection (sometimes called "long COVID"). The study involves completing questionnaires and participating in 6 weekly small group qigong sessions with an experienced qigong practitioner.

Participants will be randomized to participate in either an immediate or waitlist control group that will receive the qigong sessions starting 8 weeks later. Participants will complete 3 sets of questionnaires, each about 8 weeks apart and an interview about their experiences with qigong after completing the 6 sessions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, waitlist controlled design
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Long COVID
Intervention  ICMJE Behavioral: External Qigong
6 sessions of external qigong delivered in a group-based format once a week.
Study Arms  ICMJE
  • Experimental: Immediate
    Receives 6 sessions of qigong first.
    Intervention: Behavioral: External Qigong
  • Waitlist Control
    Receives 6 sessions of qigong after the immediate group
    Intervention: Behavioral: External Qigong
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2023)		 48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2024
Estimated Primary Completion Date January 24, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. English-speaking adults age 18 or greater
  2. History of a COVID-19 infection with lingering symptoms lasting longer than 12 weeks
  3. Willing and able to access the internet to complete questionnaires
  4. Willing and able to travel to the qigong sessions.

Exclusion Criteria:

  1. Lung scarring secondary to COVID-19 infection as evidenced by signs of parenchymal lung damage on imaging or FVC < 80% (any patient with post COVID-related shortness of breath must have PFTs to be considered for enrollment).
  2. Dementia
  3. Any other condition that makes it difficult for the individual to complete questionnaires or attend the qigong sessions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Dossett, MD, PhD, MPH 916-734-5367 mdossett@ucdavis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05675995
Other Study ID Numbers  ICMJE 1846783
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Must submit written request and complete data sharing agreement.
Current Responsible Party Michelle Dossett, University of California, Davis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Davis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP