NCT05961462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

July 24, 2023

Last Update Submit

September 4, 2023

Conditions

Long COVID-19

Keywords

Long COVID-19Exercise trainingCardiopulmonary fitnessSymptom improvement

Outcome Measures

Primary Outcomes (1)

  • Symptom improvement

    Improvement or Recovery of Long-term COVID-19 Symptoms

    Week 4

Secondary Outcomes (6)

  • Peak oxygen uptake

    Week 4

  • Quality of life measured by 12-Item Short Form Health Survey (SF12)

    Week 4

  • Anxiety measured by Generalized Anxiety Disorder 7-item scale (GAD-7)

    Week 4

  • Depression measured by Patient Health Questionnaire 9-item scale (PHQ-9)

    Week 4

  • Insomnia measured by Insomnia Severity Index (ISI)

    Week 4

  • +1 more secondary outcomes

Study Arms (2)

Exercise training group

ACTIVE COMPARATOR

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

Behavioral: Exercise training

Attention control

NO INTERVENTION

Conventional care.

Interventions

Exercise trainingBEHAVIORAL

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

Exercise training group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (6)

  • 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.

    PMID: 34312178BACKGROUND

  • 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.

    PMID: 36223120BACKGROUND

  • 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.

    PMID: 37164620BACKGROUND

  • 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.

    PMID: 36111386BACKGROUND

  • 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.

    PMID: 35120977BACKGROUND

  • 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.

    PMID: 39363376DERIVED

Related Links

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation

Study Record Dates

First Submitted

July 24, 2023

First Posted

July 27, 2023

Study Start

January 10, 2023

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

CN(1)