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Non-pharmacological and TCM-based Treatment for Long COVID Symptoms

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ClinicalTrials.gov Identifier: NCT06042777
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
TSANG Hector Wing-Hong, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
Cognitive impairment is one of the commonly reported Long COVID symptoms, mainly in terms of memory, attention, and executive function. The cognitive symptoms of Long COVID are similar to "brain fog" or "chemo brain", manifested as low energy, disorientation, difficulties in attention and communication which are common conditions in cancer patients after chemotherapy. Given the negative impact of such cognitive impairment in daily living and working, it is important to develop effective treatment and self-management techniques to enhance cognitive functions in COVID-19 survivors. Acupuncture, acupressure, dantian breathing, and qigong are promising treatment and self-management techniques to remedy the cognitive impairment in people with Long COVID. Since acupressure, dantian breathing, and qigong are feasible for self-practice, they can be trained to promote a healthy lifestyle. The present study is a randomized controlled trial to evaluate the efficacy of acupuncture, lifestyle management (including dantian breathing, qigong, and acupressure), and acupuncture + lifestyle management to improve general cognitive function of people with Long COVID symptoms, compared with wait-list control. We will recruit 100 COVID-19 survivors who experience at least mild cognitive impairment and/or self-complaint of cognitive difficulty for at least 12 weeks after clinical recovery from COVID-19 infection. They will be randomly assigned to the following groups: (1) Acupuncture Group; (2) Lifestyle Management Group; (3) Acupuncture + Lifestyle Management Group; and (4) Waitlist Control Group. Acupuncture and lifestyle management will each take 8 weeks, with two 50-min sessions per week. Primary outcome is general cognitive function. Secondary outcomes cover fatigue, physical fitness, neurocognitive function, psychological distress, and health-related quality of life, pro-inflammatory cytokines (IL-6, TNF-α) and salivary cortisol. Assessment will be conducted at baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).

Condition or disease Intervention/treatment Phase
Long Covid19 Behavioral: Acupuncture and TCM-based lifestyle management Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing Non-pharmacological TCM-based Treatments for Cognitive Impairment in People With Long COVID Symptoms: A Randomized Controlled Trial
Estimated Study Start Date : September 30, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Acupuncture
This is an 8-week (two 50-min sessions per week) treatment of acupuncture on the following fixed acupoints: bilateral Touwei (ST8), Sishencong (EX-HN1), Taiyang (EX-HN5), Shuaigu (GB8), Toulinqi (GB15), and unilateral Yintang (EX-HN3), Baihui (GV20). The treatment will be performed by registered acupuncturists. based on acupuncturists' clinical judgement, acupuncture can be performed on any of the following additional acupoints, including unilateral Shenting (GV24), Shenmen (HT7), Sanyinjiao (SP6), Taichong (LV3), Neiguan (PC6), AND Anmian (EX-HN22).
 Behavioral: Acupuncture and TCM-based lifestyle management
Non-pharmacological treatment based on traditional Chinese medicine.
Experimental: TCM-based lifestyle management
This is an integrated TCM-based training program with components of dantian breathing, Baduanjin, and self-acupressure [Yintang (EX-HN3), Shenting (GV24), Taiyang (EX-HN5), Fengchi (GB20), Neiguan (PC6), Shenmen (HT7), and Sanyinjiao (SP6)]. The treatment will last for 8 weeks (two 50-min sessions per week), and it will include health education and workshops to be delivered by trained research assistants.
 Behavioral: Acupuncture and TCM-based lifestyle management
Non-pharmacological treatment based on traditional Chinese medicine.
Experimental: Acupuncture + TCM-based lifestyle management
This is a combination of the above two arms. The participants who randomly assigned to this arm will received two acupuncture sessions and two sessions on lifestyle management every week, and the intervention duration is 8 weeks.
 Behavioral: Acupuncture and TCM-based lifestyle management
Non-pharmacological treatment based on traditional Chinese medicine.
No Intervention: Wait-list control
Participants will receive no intervention during the whole assessment period.


Outcome Measures
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Primary Outcome Measures :
  1. Global cognitive function [ Time Frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline) ]
    Overall status of cognitive function


Secondary Outcome Measures :
  1. Global cognitive function [ Time Frame: baseline and 4-week follow-up (12 weeks after baseline). ]
    Overall status of cognitive function

  2. Cardiopulmonary function [ Time Frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline). ]
  3. Fatigue [ Time Frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline). ]
  4. Health-related quality-of-life [ Time Frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline). ]
  5. Psychological distress [ Time Frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline). ]
    Depression, anxiety, and stress

  6. Neurocognitive functions [ Time Frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline). ]
    Attention, processing speed, working memory, and executive function

  7. Neurobiological outcomes [ Time Frame: baseline and post-intervention (8 weeks after baseline) ]
    IL-6, TNF-α, and cortisol


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:

  • With a diagnosis of SARS-CoV-2 infection at least 3 months prior to recruitment (to be verified based on evidence of positive RT-PCR/RAT result)
  • Tested negative of SARS-CoV-2 according to a RAT at the time of recruitment;
  • Fulfill at least one of the following conditions: (a) With at least mild cognitive impairment as assessed with Montreal Cognitive Assessment 5-minute to be conducted by the project team; (b) Self-report of at least one cognitive symptom persisting for 12 weeks or longer after clinical recovery of SARS-CoV-2 infection according to Woods Mental Fatigue Inventory.

Exclusion Criteria:

  • Having any severe cognitive impairment, mood disorder, or anxiety disorder before SARS-CoV-2 infection.
  • Having any current psychiatric disorders that require taking medication.
  • Having any current medical conditions that could interfere with cognitive functions.
  • Having epilepsy or any other unstable medical conditions.
  • Having alcoholism or drug abuse within the past 1 year.
  • Having bleeding tendency.
  • Having severe needle phobia.
  • Having heart pacemaker or other electronic devices implanted in the body.
  • Currently participating in another research studies or clinical trials.
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): NCT06042777


Contacts
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Contact: Erin Lu 27666740 erin.lu@polyu.edu.hk

Sponsors and Collaborators
The Hong Kong Polytechnic University
More Information
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Responsible Party: TSANG Hector Wing-Hong, Chair Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT06042777    
Other Study ID Numbers: P0042751
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Acute COVID-19 Syndrome
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Pathologic Processes