Effects of Exercise Training on Patients With Long COVID-19

September 4, 2023 updated by: Huan Ma, Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise training group
Exercise training containing 12 sessions of a structured aerobic exercise training program over 4 weeks (3 times per week).
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).
No Intervention: Attention control
Conventional care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom improvement
Time Frame: Week 4
Improvement or Recovery of Long-term COVID-19 Symptoms
Week 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-053-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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