Effects of Exercise Training on Patients With Long COVID-19

NCT ID: NCT05961462

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-08-30

Brief Summary

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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

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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.

Conditions

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Long COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise training group

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

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type BEHAVIORAL

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

Attention control

Conventional care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huan Ma

Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 34312178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36223120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37164620 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36111386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35120977 (View on PubMed)

Bai B, Xu M, Zhou H, Liao Y, Liu F, Liu Y, Yuan Y, Geng Q, Ma H. Effects of aerobic training on cardiopulmonary fitness in patients with long COVID-19: a randomized controlled trial. Trials. 2024 Oct 3;25(1):649. doi: 10.1186/s13063-024-08473-3.

Reference Type DERIVED
PMID: 39363376 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/books/NBK582435/

Clinical management of COVID-19: Living guideline

https://books.google.co.uk/books/about/ACSM_s_Guidelines_for_Exercise_Testing_a.html?id=rpoMEAAAQBAJ&redir_esc=y

American College of Sports Medicine Guidelines for Exercise Testing and Prescription

Other Identifiers

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KY2023-053-02

Identifier Type: -

Identifier Source: org_study_id

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