Effects of Exercise Training on Patients With Long COVID-19

Not Applicable

Completed

• Conditions: Long COVID-19
• Interventions: Behavioral: Exercise training

• Registration Number: NCT05961462
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study Start: 2023-01-10
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-27
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training group	Exercise training	Exercise training containing 12 sessions of a structured aerobic exercise training program over 4 weeks (3 times per week).

Primary Outcome Measures

Name	Time	Method
Symptom improvement	Week 4	Improvement or Recovery of Long-term COVID-19 Symptoms

Secondary Outcome Measures

Name	Time	Method
Anxiety measured by Generalized Anxiety Disorder 7-item scale (GAD-7)	Week 4	Using Generalized Anxiety Disorder 7-item scale to evaluate anxiety status.
Perceived stress measured by Perceived Stress Scale (PSS)	Week 4	Using Perceived Stress Scale to evaluate stress level.
Insomnia measured by Insomnia Severity Index (ISI)	Week 4	Using Insomnia Severity Index to evaluate insomnia status.
Peak oxygen uptake	Week 4	The cardiopulmonary fitness assessed by Cardiopulmonary Exercise Test
Quality of life measured by 12-Item Short Form Health Survey (SF12)	Week 4	Using 12-Item Short Form Health Survey to evaluate quality of life.
Depression measured by Patient Health Questionnaire 9-item scale (PHQ-9)	Week 4	Using Patient Health Questionnaire 9-item scale to evaluate depression status.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China