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

Not Applicable

Not yet recruiting

• Conditions: Long Covid19

• Registration Number: NCT06042777
• Lead Sponsor: The Hong Kong Polytechnic University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Study Start: 2023-09-30
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global cognitive function	baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)	Overall status of cognitive function

Secondary Outcome Measures

Name	Time	Method
Fatigue	baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Psychological distress	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
Neurocognitive functions	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
Health-related quality-of-life	baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Cardiopulmonary function	baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Global cognitive function	baseline and 4-week follow-up (12 weeks after baseline).	Overall status of cognitive function
Neurobiological outcomes	baseline and post-intervention (8 weeks after baseline)	IL-6, TNF-α, and cortisol