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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Long COVID Behavioral: External Qigong Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, waitlist controlled design
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Qigong for Post Acute Sequelae of COVID-19 Infection
Actual Study Start Date : January 4, 2023
Estimated Primary Completion Date : January 24, 2024
Estimated Study Completion Date : July 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Immediate
Receives 6 sessions of qigong first.
 Behavioral: External Qigong
6 sessions of external qigong delivered in a group-based format once a week.
Waitlist Control
Receives 6 sessions of qigong after the immediate group
 Behavioral: External Qigong
6 sessions of external qigong delivered in a group-based format once a week.


Outcome Measures
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Primary Outcome Measures :
  1. Change in physical health [ Time Frame: 8 weeks ]
    Change in PROMIS-29 physical health summary score from before to after intervention in all participants


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05675995


Contacts
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Contact: Michelle Dossett, MD, PhD, MPH 916-734-5367 mdossett@ucdavis.edu

Locations
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United States, California
University of California Davis Health Recruiting
Sacramento, California, United States, 95817
Contact: Michelle Dossett, MD, PhD, MPH    916-734-5367    mdossett@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
More Information
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Responsible Party: Michelle Dossett, Assistant Professor in Residence, University of California, Davis
ClinicalTrials.gov Identifier: NCT05675995    
Other Study ID Numbers: 1846783
First Posted: January 9, 2023    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Must submit written request and complete data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Dossett, University of California, Davis:
Qigong
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases