- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05675995
Qigong for Post Acute Sequelae of COVID-19 Infection
Study Overview
Detailed Description
The purpose of this study is to determine whether a combination of external and internal 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 in person 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California Davis Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking adults age 18 or greater
- History of a COVID-19 infection with lingering symptoms lasting longer than 12 weeks
- Willing and able to access the internet to complete questionnaires
- Willing and able to travel to the qigong sessions to participate in person in Sacramento, CA.
Exclusion Criteria:
- 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).
- Dementia
- Any other condition that makes it difficult for the individual to complete questionnaires or attend the qigong sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate
Receives 6 sessions of qigong first.
|
6 sessions of combined external and internal qigong delivered in a group-based format once a week.
|
|
Other: Waitlist Control
Receives 6 sessions of qigong after the immediate group
|
6 sessions of combined external and internal qigong delivered in a group-based format once a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in physical and mental health
Time Frame: 8 weeks
|
Changes in PROMIS-29 summary scores from before to after intervention in all participants
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Post-Acute COVID-19 Syndrome
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Breathing Exercises
- Qigong
Other Study ID Numbers
- 1846783
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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