Effects of Exercise Training on Patients With Long COVID-19

Long COVID-19 Clinical Trial

Official title:

Effects of Exercise Training on Patients With Long COVID-19, a Single-center, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05961462
• Other study ID #: KY2023-053-02
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old;

2. 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

3. 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;

4. The patient understands and signs the informed consent form.

Exclusion Criteria:

1. Infected with COVID-19 within one month

2. Conditions that may be worsened by exercise, such as acute cardiac insufficiency, exercise asthma, epilepsy, etc.

3. Physical disabilities caused by bone and joint or neuromuscular diseases,

4. Complicated with other serious diseases (such as unstable angina, resting oxygen saturation < 93%, untreated heart failure, uncontrolled arrhythmia, uncontrolled hypertension, uncontrolled type 2 diabetes),

5. Women during pregnancy and lactation;

6. Patients was assessed unsuitable for this study.

Related Conditions & MeSH terms

• COVID-19
• Long COVID-19

Intervention

Behavioral:
• Exercise training
Patients randomized to the exercise group will be offered aerobic exercise plan containing 12 sessions over 4 weeks (3 times per week).

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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 May 10:bjsports-2022-106681. doi: 10.1136/bjsports-2022-106681. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom improvement	Improvement or Recovery of Long-term COVID-19 Symptoms	Week 4
Secondary	Peak oxygen uptake	The cardiopulmonary fitness assessed by Cardiopulmonary Exercise Test	Week 4
Secondary	Quality of life measured by 12-Item Short Form Health Survey (SF12)	Using 12-Item Short Form Health Survey to evaluate quality of life.	Week 4
Secondary	Anxiety measured by Generalized Anxiety Disorder 7-item scale (GAD-7)	Using Generalized Anxiety Disorder 7-item scale to evaluate anxiety status.	Week 4
Secondary	Depression measured by Patient Health Questionnaire 9-item scale (PHQ-9)	Using Patient Health Questionnaire 9-item scale to evaluate depression status.	Week 4
Secondary	Insomnia measured by Insomnia Severity Index (ISI)	Using Insomnia Severity Index to evaluate insomnia status.	Week 4
Secondary	Perceived stress measured by Perceived Stress Scale (PSS)	Using Perceived Stress Scale to evaluate stress level.	Week 4

External Links

•   American College of Sports Medicine Guidelines for Exercise Testing and Prescription
•   Clinical management of COVID-19: Living guideline