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

Testing Non-pharmacological TCM-based Treatments for Cognitive Impairment in People With Long COVID Symptoms: A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06042777
Enrollment
100
Registered
2023-09-21
Start date
2023-09-30
Completion date
2024-08-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long Covid19

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).

Interventions

BEHAVIORALAcupuncture and TCM-based lifestyle management

Non-pharmacological treatment based on traditional Chinese medicine.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Global cognitive functionbaseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)Overall status of cognitive function

Secondary

MeasureTime frameDescription
Cardiopulmonary functionbaseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Fatiguebaseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Health-related quality-of-lifebaseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Global cognitive functionbaseline and 4-week follow-up (12 weeks after baseline).Overall status of cognitive function
Neurocognitive functionsbaseline, 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
Neurobiological outcomesbaseline and post-intervention (8 weeks after baseline)IL-6, TNF-α, and cortisol
Psychological distressbaseline, 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

Contacts

Primary ContactErin Lu
erin.lu@polyu.edu.hk27666740

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026