Long Covid19NCT06042777
Non-pharmacological and TCM-based Treatment for Long COVID Symptoms
A study testing Acupuncture and TCM-based lifestyle management in people with Long Covid19, run by The Hong Kong Polytechnic University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid19
- What is being tested?
- Acupuncture and TCM-based lifestyle management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Having severe needle phobia.
- Having heart pacemaker or other electronic devices implanted in the body.
- Currently participating in another research studies or clinical trials.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Testing Non-pharmacological TCM-based Treatments for Cognitive Impairment in People With Long COVID Symptoms: A Randomized Controlled Trial
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
- Being tested
- Acupuncture and TCM-based lifestyle management
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and TCM-based lifestyle managementBehavioural
Non-pharmacological treatment based on traditional Chinese medicine.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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). Receives: Behavioral: Acupuncture and TCM-based lifestyle management |
| TCM-based lifestyle management | Experimental | 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. Receives: Behavioral: Acupuncture and TCM-based lifestyle management |
| Acupuncture + TCM-based lifestyle management | Experimental | 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. Receives: Behavioral: Acupuncture and TCM-based lifestyle management |
| Wait-list control | No intervention | Participants will receive no intervention during the whole assessment period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive function
Overall status of cognitive function
Measured: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)
Secondary outcomes (7)
Global cognitive function
Overall status of cognitive function
Measured: baseline and 4-week follow-up (12 weeks after baseline).
Cardiopulmonary function
Measured: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Fatigue
Measured: baseline, 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-life
Measured: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Psychological distress
Depression, anxiety, and stress
Measured: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Neurocognitive functions
Attention, processing speed, working memory, and executive function
Measured: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline), and 4-week follow-up (12 weeks after baseline).
Neurobiological outcomes
IL-6, TNF-α, and cortisol
Measured: baseline and post-intervention (8 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start30 Sep 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid19Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042777
- Sponsor's protocol ID
- P0042751
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Non-pharmacological TCM-based Treatments for Cognitive Impairment in People With Long COVID Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06042777
- Acronym / sponsor ID
- P0042751
- Conditions
- Long Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Behavioral: Acupuncture and TCM-based lifestyle managementThis 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). |
| TCM-based lifestyle management | Experimental | Behavioral: Acupuncture and TCM-based lifestyle managementThis 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. |
| Acupuncture + TCM-based lifestyle management | Experimental | Behavioral: Acupuncture and TCM-based lifestyle managementThis 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. |
| Wait-list control | No intervention | –Participants will receive no intervention during the whole assessment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture and TCM-based lifestyle managementNon-pharmacological treatment based on traditional Chinese medicine. | Behavioural | Acupuncture, Acupuncture + TCM-based lifestyle management, TCM-based lifestyle management |
Primary outcome
Global cognitive function
Time frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)
Overall status of cognitive function
7 secondary outcomes
Global cognitive function
Time frame: baseline and 4-week follow-up (12 weeks after baseline).
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).
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).
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).
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).
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).
Neurobiological outcomes
Time frame: baseline and post-intervention (8 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and TCM-based lifestyle management in people with Long Covid19, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Lu (27666740, erin.lu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive function (time frame: baseline, mid-intervention (4 weeks after baseline), post-intervention (8 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.