Qigong for Post Acute Sequelae of COVID-19 Infection

• Sponsor: University of California, Davis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05675995
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, waitlist controlled designRandomized, 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: Jan 4, 2023
• Anticipated Primary Completion Date: Jan 24, 2024
• Anticipated Study Completion Date: Jul 30, 2024

Arms and Interventions

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.
Other: 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

Primary Outcome Measures

1. Change in physical health [8 weeks]

   Change in PROMIS-29 physical health summary score from before to after intervention in all participants

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis Health	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michelle Dossett, Assistant Professor in Residence, University of California, Davis
• ClinicalTrials.gov Identifier: NCT05675995
• Other Study ID Numbers: 1846783
• First Posted: Jan 9, 2023
• Last Update Posted: Jan 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michelle Dossett, Assistant Professor in Residence, University of California, Davis: Qigong
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jan 9, 2023