Back to resultsEffects of Exercise Training on Patients With Long COVID-19
Primary Purpose
Long COVID-19
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Long COVID-19 focused on measuring Long COVID-19, Exercise training, Cardiopulmonary fitness, Symptom improvement
Eligibility Criteria
Inclusion Criteria: 18-75 years old; Complicated with at least one of the following symptoms within 3 months after COVID-19 infection, lasts for at least 2 months, and is not caused by other diseases: Cough, fatigue, memory loss, concentration problems, palpitation easily or rapid heartbeat, chest tightness or chest pain, pain (head, limbs, lower back), slow thinking or reaction, eye discomfort or decreased vision, shortness of breath or difficulty breathing at rest, diarrhea, loss of taste or decreased taste, insomnia, hair loss, other new symptoms after COVID-19 infection Tested positive for COVID-19 quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR) or antigen kit and turned negative for at least 4 weeks before inclusion; The patient understands and signs the informed consent form. Exclusion Criteria: Infected with COVID-19 within one month Conditions that may be worsened by exercise, such as acute cardiac insufficiency, exercise asthma, epilepsy, etc. Physical disabilities caused by bone and joint or neuromuscular diseases, Complicated with other serious diseases (such as unstable angina, resting oxygen saturation < 93%, untreated heart failure, uncontrolled arrhythmia, uncontrolled hypertension, uncontrolled type 2 diabetes), Women during pregnancy and lactation; Patients was assessed unsuitable for this study.
Sites / Locations
- Guangdong Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Exercise training group
Attention control
Arm Description
Exercise training containing 12 sessions of a structured aerobic exercise training program over 4 weeks (3 times per week).
Conventional care.
Outcomes
Primary Outcome Measures
Symptom improvement
Improvement or Recovery of Long-term COVID-19 Symptoms
Secondary Outcome Measures
Peak oxygen uptake
The cardiopulmonary fitness assessed by Cardiopulmonary Exercise Test
Quality of life measured by 12-Item Short Form Health Survey (SF12)
Using 12-Item Short Form Health Survey to evaluate quality of life.
Anxiety measured by Generalized Anxiety Disorder 7-item scale (GAD-7)
Using Generalized Anxiety Disorder 7-item scale to evaluate anxiety status.
Depression measured by Patient Health Questionnaire 9-item scale (PHQ-9)
Using Patient Health Questionnaire 9-item scale to evaluate depression status.
Insomnia measured by Insomnia Severity Index (ISI)
Using Insomnia Severity Index to evaluate insomnia status.
Perceived stress measured by Perceived Stress Scale (PSS)
Using Perceived Stress Scale to evaluate stress level.
Full Information
NCT ID
NCT05961462
First Posted
July 24, 2023
Last Updated
September 4, 2023
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05961462
Brief Title
Effects of Exercise Training on Patients With Long COVID-19
Official Title
Effects of Exercise Training on Patients With Long COVID-19, a Single-center, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Effects of Exercise training on Patients With Long COVID-19, is a single-center, randomized, controlled trial designed to evaluate the effects of 4- week aerobic exercise administered to patients with long COVID-19 symptoms. The main outcome is cardiopulmonary fitness and long COVID-19 symptom improvement. Quality of life, depression, anxiety, insomnia status and perceived stress will also be assessed before and after the exercise program.
Detailed Description
Long COVID-19 symptoms are characterized by systemic deterioration of the entire body, leading to significant physiological and functional imbalances. Common symptoms may be related to decreased short-term or long-term exercise capacity resulting from organ tissue damage, such as myocardial and pulmonary dysfunction. Currently, even vaccines and medications cannot effectively address the long-term consequences of COVID-19. Exercise training has been proven to improve exercise capacity and quality of life during the recovery period for various chronic disease patients.
A total of 24 patients will be included in the study. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 4-week aerobic exercise training or attention control.The main objective is to assess the effects of a 4-week aerobic exercise training program on cardiopulmonary fitness and long COVID-19 symptom improvement. Secondary objectives include: to characterize baseline and intervention-related changes in quality of life, depression, anxiety, insomnia status and perceived stress status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID-19
Keywords
Long COVID-19, Exercise training, Cardiopulmonary fitness, Symptom improvement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise training group
Arm Type
Active Comparator
Arm Description
Exercise training containing 12 sessions of a structured aerobic exercise training program over 4 weeks (3 times per week).
Arm Title
Attention control
Arm Type
No Intervention
Arm Description
Conventional care.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Patients randomized to the exercise group will be offered aerobic exercise plan containing 12 sessions over 4 weeks (3 times per week).
Primary Outcome Measure Information:
Title
Symptom improvement
Description
Improvement or Recovery of Long-term COVID-19 Symptoms
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Peak oxygen uptake
Description
The cardiopulmonary fitness assessed by Cardiopulmonary Exercise Test
Time Frame
Week 4
Title
Quality of life measured by 12-Item Short Form Health Survey (SF12)
Description
Using 12-Item Short Form Health Survey to evaluate quality of life.
Time Frame
Week 4
Title
Anxiety measured by Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
Using Generalized Anxiety Disorder 7-item scale to evaluate anxiety status.
Time Frame
Week 4
Title
Depression measured by Patient Health Questionnaire 9-item scale (PHQ-9)
Description
Using Patient Health Questionnaire 9-item scale to evaluate depression status.
Time Frame
Week 4
Title
Insomnia measured by Insomnia Severity Index (ISI)
Description
Using Insomnia Severity Index to evaluate insomnia status.
Time Frame
Week 4
Title
Perceived stress measured by Perceived Stress Scale (PSS)
Description
Using Perceived Stress Scale to evaluate stress level.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years old;
Complicated with at least one of the following symptoms within 3 months after COVID-19 infection, lasts for at least 2 months, and is not caused by other diseases: Cough, fatigue, memory loss, concentration problems, palpitation easily or rapid heartbeat, chest tightness or chest pain, pain (head, limbs, lower back), slow thinking or reaction, eye discomfort or decreased vision, shortness of breath or difficulty breathing at rest, diarrhea, loss of taste or decreased taste, insomnia, hair loss, other new symptoms after COVID-19 infection
Tested positive for COVID-19 quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR) or antigen kit and turned negative for at least 4 weeks before inclusion;
The patient understands and signs the informed consent form.
Exclusion Criteria:
Infected with COVID-19 within one month
Conditions that may be worsened by exercise, such as acute cardiac insufficiency, exercise asthma, epilepsy, etc.
Physical disabilities caused by bone and joint or neuromuscular diseases,
Complicated with other serious diseases (such as unstable angina, resting oxygen saturation < 93%, untreated heart failure, uncontrolled arrhythmia, uncontrolled hypertension, uncontrolled type 2 diabetes),
Women during pregnancy and lactation;
Patients was assessed unsuitable for this study.
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34312178
Citation
Crook H, Raza S, Nowell J, Young M, Edison P. Long covid-mechanisms, risk factors, and management. BMJ. 2021 Jul 26;374:n1648. doi: 10.1136/bmj.n1648. Erratum In: BMJ. 2021 Aug 3;374:n1944.
Results Reference
background
PubMed Identifier
36223120
Citation
Durstenfeld MS, Sun K, Tahir P, Peluso MJ, Deeks SG, Aras MA, Grandis DJ, Long CS, Beatty A, Hsue PY. Use of Cardiopulmonary Exercise Testing to Evaluate Long COVID-19 Symptoms in Adults: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236057. doi: 10.1001/jamanetworkopen.2022.36057.
Results Reference
background
PubMed Identifier
37164620
Citation
Longobardi I, Goessler K, de Oliveira Junior GN, Prado DMLD, Santos JVP, Meletti MM, de Andrade DCO, Gil S, Boza JASO, Lima FR, Gualano B, Roschel H. Effects of a 16-week home-based exercise training programme on health-related quality of life, functional capacity, and persistent symptoms in survivors of severe/critical COVID-19: a randomised controlled trial. Br J Sports Med. 2023 Oct;57(20):1295-1303. doi: 10.1136/bjsports-2022-106681. Epub 2023 May 10.
Results Reference
background
PubMed Identifier
36111386
Citation
Jimeno-Almazan A, Franco-Lopez F, Buendia-Romero A, Martinez-Cava A, Sanchez-Agar JA, Sanchez-Alcaraz Martinez BJ, Courel-Ibanez J, Pallares JG. Rehabilitation for post-COVID-19 condition through a supervised exercise intervention: A randomized controlled trial. Scand J Med Sci Sports. 2022 Dec;32(12):1791-1801. doi: 10.1111/sms.14240. Epub 2022 Sep 23.
Results Reference
background
PubMed Identifier
35120977
Citation
Josephson RA. Cardiac rehabilitation 2022. Prog Cardiovasc Dis. 2022 Jan-Feb;70:1. doi: 10.1016/j.pcad.2022.01.010. Epub 2022 Feb 1. No abstract available.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/books/NBK582435/
Description
Clinical management of COVID-19: Living guideline
URL
https://books.google.co.uk/books/about/ACSM_s_Guidelines_for_Exercise_Testing_a.html?id=rpoMEAAAQBAJ&redir_esc=y
Description
American College of Sports Medicine Guidelines for Exercise Testing and Prescription
Learn more about this trial
Effects of Exercise Training on Patients With Long COVID-19
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