Clinical trial NCT06042777: Non-pharmacological and TCM-based Treatment for Long COVID Symptoms
Official title: Testing Non-pharmacological TCM-based Treatments for Cognitive Impairment in People With Long COVID Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long Covid19
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Global cognitive function
timeFrame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)
Secondary outcomes:
measure: Global cognitive function
timeFrame: baseline and 4-week follow-up (12 weeks after baseline).
measure: Cardiopulmonary function
timeFrame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
measure: Fatigue
timeFrame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
measure: Health-related quality-of-life
timeFrame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
measure: Psychological distress
timeFrame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
measure: Neurocognitive functions
timeFrame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
measure: Neurobiological outcomes
timeFrame: baseline and post-intervention (8 weeks after baseline)
Other outcomes:
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