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

NCT ID: NCT06042777

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-08-31

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).

Conditions

Long Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Acupuncture and TCM-based lifestyle management

Intervention Type: BEHAVIORAL

Non-pharmacological treatment based on traditional Chinese medicine.

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.

Group Type: EXPERIMENTAL

Acupuncture and TCM-based lifestyle management

Intervention Type: BEHAVIORAL

Non-pharmacological treatment based on traditional Chinese medicine.

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.

Group Type: EXPERIMENTAL

Acupuncture and TCM-based lifestyle management

Intervention Type: BEHAVIORAL

Non-pharmacological treatment based on traditional Chinese medicine.

Wait-list control

Participants will receive no intervention during the whole assessment period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture and TCM-based lifestyle management

Non-pharmacological treatment based on traditional Chinese medicine.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

TSANG Hector Wing-Hong

Chair Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Erin Lu

Role: CONTACT

erin.lu@polyu.edu.hk

27666740

Other Identifiers

P0042751

Identifier Type: -

Identifier Source: org_study_id