search
Back to results

Acupressure and Qigong in Chronic Fatigue Post COVID-19. (ACUQiG)

Primary Purpose

COVID-19, Post-COVID-19 Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
self- applied acupressure plus Qigong course plus advice literature
advice literature with naturopathy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring post COVID-19, sequelae, chronic fatigue

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. diagnosis of chronic fatigue (after SARS-CoV2 infection)
  2. with at least 3 of 7 criteria at time of study inclusion: sleeping disorder, headaches, joint pain/muscle pain, anxiety/depression, memory impairment/ concentration problems, anosmia, exercise intolerance.
  3. acute SARS-CoV2 infection at least 12 weeks ago
  4. age 18-60 years
  5. visual analogue scale (0-100 mm) physical resilience of maximum 60 mm
  6. SF-36 physical function of maximum 65
  7. technically equipped to participate in the online intervention and willing to follow the study procedure, acupressure and Qigong to perform the exercise series at home
  8. written informed consent available.

Exclusion Criteria:

  1. fatigue already present before the SARS-CoV2 infection
  2. other underlying diseases leading to symptoms of chronic fatigue, such as major depression, oncological diseases, multiple sclerosis, fibromyalgia and drug abuse
  3. other serious underlying diseases, such as severe pulmonary, cardiac, psychiatric or infectious diseases, which could interfere with study participation or affect the results
  4. ongoing opioid therapy or opioid therapy in the week prior to study entry
  5. chronic use of cannabinoids before or during the study.
  6. start of psychotherapy or interruption of ongoing therapy during study participation
  7. female participants: pregnancy or breastfeeding
  8. participation in another clinical intervention study during study participation
  9. ongoing pension procedure or planned claiming of a pension procedure due to disability
  10. planned inpatient rehabilitation measures during study participation due to PostCOVID-19 -

Sites / Locations

  • Charité Universitätsmedizin Campus MitteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

self- applied acupressure plus Qigong plus advice literature

advice literature

Arm Description

daily 20 min of self- applied acupressure over 8 weeks on acupuncture points Yintang, LI4, Pe6, ST36, SP6 and depending on further symptoms plus DU23/24 in hyposmia, LU7 in dyspnoea, GB34 in pain conditions, GB20 in headache OR Anmian in sleeping disorders. The 16 sessions of 45 min Qigong course over 8 weeks will contain live online guided exercises with breathing, stretching and tapping of meridians and exercises such as the crane exercise.

advice literature contains naturopathic remedies such as application of massage-oils, use of herbal teas, meditation techniques, breathing exercises for reconvalescence after COVID19.

Outcomes

Primary Outcome Measures

SF-36 Physical Function subscale
Primary study objective is to assess the changes in the mean score of the SF-36 Physical Function subscale between the two study arms assessing the degree of fatigue.

Secondary Outcome Measures

EQ5D (EuroQoL 5 domains)
disease specific QoL
SF36 PFS (Short Form 36 physical function subscale)
changes in the mean score of the SF-36 Physical Function subscale- assessing the degree of fatigue
Chalder Fatigue-Scale
Fatigue severity
VAS physical resilience (visual analogue scale)
visual analogue scale for subjective physical resilience
PHQ9 (Patient Health Questionnaire 9)
Patient Health Questionnaire assessing depression
VAS pain (visual analogue scale)
visual analogue scale for subjective pain
hand grip strength
hand grip strength
Spirometry
forced expiratory volume
autonomic dysfunction orthostasis test
heart rate and blood pressure analysis in orthostasis
d2- test
test for concentration- ability to focus
qualitative substudy
interviews regarding experience of illness and therapy

Full Information

First Posted
March 18, 2022
Last Updated
January 19, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT05289154
Brief Title
Acupressure and Qigong in Chronic Fatigue Post COVID-19.
Acronym
ACUQiG
Official Title
Self- Applied Acupressure and Online Qigong for Patients Suffering From Chronic Fatigue After Corona Virus Infection 19 (COVID-19) - a Randomized Controlled Mixed-methods Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Karl and Veronica Carstens Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
International observational studies confirm the high incidence of post-infectious residual syndrome after infection with severe acute respiratory syndrome corona virus 2 (SARS-COV2), which can occur in 10-15% of all infected persons, regardless of the severity of the acute infection. Post corona virus disease 19 (postCOVID-19) patients suffer mostly from symptoms such as fatigue, muscle pain, problems to focus, depression and sleep disturbances. So far, there are no results of interventional studies for the treatment of chronic fatigue post COVID-19, but there are indicators that post COVID-19 syndrome is a chronic subclinical inflammation, similar to Chronic Fatigue Syndrome / Myalgic Encephalomyelitis CSF/ME, which also often develops from a postviral syndrome. Previously tested and effective strategies for the treatment of chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME) will be tested in the treatment of chronic fatigue postCOVID-19, in this randomized controlled trial a combination of acupressure and Qigong. The aim of this project is to evaluate an acupressure treatment plus a Qigong exercise series specifically tailored for chronic fatigue postCOVID-19 , used daily by the patients themselves and regularly supervised, in comparison to the advice literature on the treatment of PostCOVID-19 syndrome alone.
Detailed Description
Prospective two-arm (parallel groups) randomised controlled confirmatory intervention study with mixed methods approach in 2x 100 patients (n=200). Intervention: self-applied acupressure and online Qigong course over 8 weeks and follow up at week 16. Group 1: Acupressure + Qigong: Massage of the points daily for 3 minutes per point with the finger or an acupuncture pen (some points can be massaged bilaterally, therefore total approx. 20 min). In addition, twice a week an online guided Qigong course with a duration of 30-45 min. The patients should practise Qigong at least 3 times a week (including the course date). In addition, all patients will receive the guidebook literature for the treatment of complaints after SARS-CoV2 infection. Group 2: Patients will receive advice literature on the treatment of chronic fatigue after SARS-CoV2 infection. After the end of this study the patients of this group will receive written information and video material regarding the acupressure and Qigong exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Post-COVID-19 Syndrome
Keywords
post COVID-19, sequelae, chronic fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised controlled, confirmatory intervention study with mixed methods approach
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
self- applied acupressure plus Qigong plus advice literature
Arm Type
Experimental
Arm Description
daily 20 min of self- applied acupressure over 8 weeks on acupuncture points Yintang, LI4, Pe6, ST36, SP6 and depending on further symptoms plus DU23/24 in hyposmia, LU7 in dyspnoea, GB34 in pain conditions, GB20 in headache OR Anmian in sleeping disorders. The 16 sessions of 45 min Qigong course over 8 weeks will contain live online guided exercises with breathing, stretching and tapping of meridians and exercises such as the crane exercise.
Arm Title
advice literature
Arm Type
Active Comparator
Arm Description
advice literature contains naturopathic remedies such as application of massage-oils, use of herbal teas, meditation techniques, breathing exercises for reconvalescence after COVID19.
Intervention Type
Other
Intervention Name(s)
self- applied acupressure plus Qigong course plus advice literature
Intervention Description
daily self applied acupressure over 20min plus 2 times per week online live Qigong course of each 45min- both over 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
advice literature with naturopathy
Intervention Description
advice literature with naturopathic remedies will be handed out and application will be supported with dairies and phone calls
Primary Outcome Measure Information:
Title
SF-36 Physical Function subscale
Description
Primary study objective is to assess the changes in the mean score of the SF-36 Physical Function subscale between the two study arms assessing the degree of fatigue.
Time Frame
week 8
Secondary Outcome Measure Information:
Title
EQ5D (EuroQoL 5 domains)
Description
disease specific QoL
Time Frame
week 8 and 16
Title
SF36 PFS (Short Form 36 physical function subscale)
Description
changes in the mean score of the SF-36 Physical Function subscale- assessing the degree of fatigue
Time Frame
week 16
Title
Chalder Fatigue-Scale
Description
Fatigue severity
Time Frame
week 8 and 16
Title
VAS physical resilience (visual analogue scale)
Description
visual analogue scale for subjective physical resilience
Time Frame
week 8 and 16
Title
PHQ9 (Patient Health Questionnaire 9)
Description
Patient Health Questionnaire assessing depression
Time Frame
week 8 and 16
Title
VAS pain (visual analogue scale)
Description
visual analogue scale for subjective pain
Time Frame
week 8 and 16
Title
hand grip strength
Description
hand grip strength
Time Frame
week 8 and 16
Title
Spirometry
Description
forced expiratory volume
Time Frame
week 8 and 16
Title
autonomic dysfunction orthostasis test
Description
heart rate and blood pressure analysis in orthostasis
Time Frame
week 8 and 16
Title
d2- test
Description
test for concentration- ability to focus
Time Frame
week 8 and 16
Title
qualitative substudy
Description
interviews regarding experience of illness and therapy
Time Frame
week 8 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of chronic fatigue (after SARS-CoV2 infection) with at least 3 of 7 criteria at time of study inclusion: sleeping disorder, headaches, joint pain/muscle pain, anxiety/depression, memory impairment/ concentration problems, anosmia, exercise intolerance. acute SARS-CoV2 infection at least 12 weeks ago age 18-60 years visual analogue scale (0-100 mm) physical resilience of maximum 60 mm SF-36 physical function of maximum 65 technically equipped to participate in the online intervention and willing to follow the study procedure, acupressure and Qigong to perform the exercise series at home written informed consent available. Exclusion Criteria: fatigue already present before the SARS-CoV2 infection other underlying diseases leading to symptoms of chronic fatigue, such as major depression, oncological diseases, multiple sclerosis, fibromyalgia and drug abuse other serious underlying diseases, such as severe pulmonary, cardiac, psychiatric or infectious diseases, which could interfere with study participation or affect the results ongoing opioid therapy or opioid therapy in the week prior to study entry chronic use of cannabinoids before or during the study. start of psychotherapy or interruption of ongoing therapy during study participation female participants: pregnancy or breastfeeding participation in another clinical intervention study during study participation ongoing pension procedure or planned claiming of a pension procedure due to disability planned inpatient rehabilitation measures during study participation due to PostCOVID-19 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Dietzel, MD
Phone
+49 30 450 529 002
Email
joanna.dietzel@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Ortiz, MD
Phone
+49 30 450 529 002
Email
miriam.ortiz@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benno Brinkhaus, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benno Brinkhaus, MD, PhD
Phone
+49 30 450 529 002
Email
benno.brinkhaus@charite.de
First Name & Middle Initial & Last Name & Degree
Joanna Dietzel, MD
Phone
+49 30 450 529 005
Email
joanna.dietzel@charite.de
First Name & Middle Initial & Last Name & Degree
Joanna Dietzel, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33273026
Citation
Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, Noel A, Gunning S, Hatrick J, Hamilton S, Elvers KT, Hyams C, Bibby A, Moran E, Adamali HI, Dodd JW, Maskell NA, Barratt SL. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021 Apr;76(4):399-401. doi: 10.1136/thoraxjnl-2020-216086. Epub 2020 Dec 3.
Results Reference
background
PubMed Identifier
32644129
Citation
Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
Results Reference
background
PubMed Identifier
31607352
Citation
Chan JSM, Ng SM, Yuen LP, Chan CLW. Qigong exercise for chronic fatigue syndrome. Int Rev Neurobiol. 2019;147:121-153. doi: 10.1016/bs.irn.2019.08.002.
Results Reference
background
PubMed Identifier
20617920
Citation
Jason L, Brown M, Evans M, Anderson V, Lerch A, Brown A, Hunnell J, Porter N. Measuring substantial reductions in functioning in patients with chronic fatigue syndrome. Disabil Rehabil. 2011;33(7):589-98. doi: 10.3109/09638288.2010.503256. Epub 2010 Jul 9.
Results Reference
background
PubMed Identifier
3295732
Citation
Glasier CM, Seibert JJ, Williamson SL, Seibert RW, Corbitt SL, Rodgers AB, Lange TA. High resolution ultrasound characterization of soft tissue masses in children. Pediatr Radiol. 1987;17(3):233-7. doi: 10.1007/BF02388167.
Results Reference
background
PubMed Identifier
2092449
Citation
Weyand CM, Goronzy JJ. The role of infectious agents in the etiopathogenesis of chronic rheumatic diseases. Verh Dtsch Ges Inn Med. 1990;96:319-24. doi: 10.1007/978-3-642-84317-4_58. No abstract available.
Results Reference
background

Learn more about this trial

Acupressure and Qigong in Chronic Fatigue Post COVID-19.

We'll reach out to this number within 24 hrs