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COVID-19NCT05449379

Evaluation of Effectiveness of Proprietary Rehabilitation Program in Patients After COVID-19 Infection

A study testing Respiratory training with the use of resistance set on respiratory muscle trainer and Respiratory training without resistance set on respiratory muscle trainer in people with COVID-19 and Rehabilitation, run by Medical University of Bialystok at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is to evaluate the influence of 6 week physical training and respiratory rehabilitation performed in outpatients rehabilitation clinic on quality of life, symptoms, physical endurance, mental state, force of respiratory and skeletal muscles and myokines profile in patients after COVID-19 infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Rehabilitation
What is being tested?
Respiratory training with the use of resistance set on respiratory muscle trainer and Respiratory training without resistance set on respiratory muscle trainer
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 sitePoland
Study dates
1 Jun 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COVID 19 infection confirmed with a positive PCR (polymerase chain reaction) SARS-CoV-2 (Severe Scute Respiratory Syndrome coronavirus type 2) test less than 12 moths prior to intervention
  • more than 14 days from the day of obtaining a positive PCR test result for SARS-CoV-2 or discharge from hospital.
  • mMRC (modified Medical Research Council) score ≥1
  • age >18 years
  • informed consent signed by patient to conduct the study

Who cannot join

  • severe pulmonary disease (e.g. COPD)
  • the functional state that makes it impossible to carry out the pre-examination and improvement program
  • severe chest pain
  • worsening dyspnea
  • hemoptysis
  • worsening dry cough
Show all 9Show fewer
  • syncope
  • worsening oedema of extremities
  • myocarditis (less than 6 months from acute phase)

Trial locations and contacts

1 site in 1 country.

Mariusz Ciolkiewicz, PhD contact

858318315 ext. 0048

mariusz.ciolkiewicz@umb.edu.pl

Mariusz Wojciuk, PhD contact

858318315 ext. 0048

mariusz.wojciuk@umb.edu.pl

Poland1 site, 1 recruiting

  • Medical University of Bialystok, Department of Rehabilitation

    Bialystok, Podlaskie Voivodeship, 15-089

    Mariusz J Ciołkiewicz, PhD, 0048858318315 ext. 0048858318315, mariusz.ciolkiewicz@umb.edu.pl

    Mariusz Wojciuk, PhD, 0048858318315, mariusz.wojciuk@umb.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Evaluation of Influence of Proprietary Physical Training Program on Quality of Life, Physical Endurance, Function of Muscles and Myokines Profile in Patients After COVID-19 Infection.

The aim of the study is to evaluate the influence of 6 week physical training and respiratory rehabilitation performed in outpatients rehabilitation clinic on quality of life, symptoms, physical endurance, mental state, force of respiratory and skeletal muscles and myokines profile in patients after COVID-19 infection.

Read the detailed description

The study of interventional, prospective character will be conducted in Rehabilitation Department of Medical University of Bialystok on total group of 60 participants less than 12 months after COVID-19 (coronavirus disease) infection. In all participants medical anamnesis, physical examination (including chest wall mobility), anthropometric measures, The Short Physical Performance Battery (SPPB), 6-minute walking test (6MWT six minute walking test) and treadmill stress test will be performed.

Medical history will consist of questions regarding course of COVID-19 and its consequences with special emphasis on dyspnea during daily activities in Borg scale and dyspnea in daily living in mMRC scale, coexisting diseases, treatment, lifestyle, etc. Quality of life will be assessed with use of The Short Form (36) Health Survey - SF-36), Post-COVID-19 Functional Status (PCFS] scale and Modified Fatigue Impact Scale (MFIS). Mental status will be evaluated with the use of Beck Depression Inventory (BDI) and Hamilton Depression Scale (HAMD)) Biochemical measures will be performed including, among others, myokines such as BDNF (brain-derived neurotrophic factor), adiponectin, fibroblast growth factor 21 (FGF21), resistin, myonectin and inflammatory markers, such as interleukin 6 ((Il-6), C-reactive protein (CRP).

Fasting venous blood will be collected in 2 tubes each a 10 ml, one dedicated to obtain serum ("on clot"), second with heparin) to perform biochemical analyses, In clinical evaluation measurement of respiratory (inspiratory and expiratory) muscles force with use of device MicroRPM (respiratory pressure meter), hand grip strength with use of hand dynamometer (Jamar) and strength of quadriceps muscles with use of digital dynamometer (AXIS) will be performed. During first visit also ECG (electrocardiogram), six minute walking test and treadmill stress test will be done. All patients will have diaphragm ultrasound with measurement of diaphragm thickness.

Patient will be randomized to the control and interventional groups. Control group will be subjected to the safe protocol of 6 week physical training (aerobic training, resistance training, general improvement training, stretching training and respiratory rehabilitation) adjusted to the clinical state of patients. Additionally patients will be recommended to perform a set of exercises at home under a supervision of physiotherapist.

Patients from interventional group in addition to the training protocol will be subjected to additional resistance respiratory training with the use of respiratory muscle trainer (Philips Respironics Threshold IMT). Control group will have placebo with no resistance set on respiratory muscle trainer (Philips Respironics Threshold IMT). The study will be double blind, patients will be unaware of being assigned to a group and investigators assessing functional state in the next stages of the study will not conduct rehabilitation and will not be aware of the allocation of patients to groups. Physiotherapists conducting rehabilitation will receive detailed, individual guidelines regarding the training parameters of each patient. In addition, both groups will be educated on rules of safe physical activity and how to deal with troublesome symptoms.

Physical endurance (6 MWT, treadmill stress test), respiratory function, respiratory and peripheral muscle strength, other functional tests (SPPB), biochemical determinations, dyspnea (mMRC, Borg scale), quality of life (SF-36, PCFS, MFIS) mental state (BDI, HAMD), chest wall mobility and diaphragm ultrasound will be assessed at the beginning and end of the intervention. In addition, an analysis of the potential change in lifestyle of all patients will be carried out using accelerometry counting daily number of steps and assessing physical activity. Each patient will be equipped with basic exercise equipment and the necessary monitors of physical activity and vital signs to carry out the recommended activities at home (except for training units in the outpatient clinic). A reassessment of the long-term effects will be performed six months after the end of the exercises and will include 6 MWT, treadmill stress test, SPPB, spirometry, measurement of respiratory muscles force, handgrip strength, strength of quadriceps muscles, SF-36, PCFS, MFIS, BDI, HAMD, assessment of dyspnea in Borg scale during daily activities, mMRC, blood samples for biochemical analyses, ), chest wall mobility and diaphragm ultrasound . Patients in both groups will be monitored with the use of accelerometers in order to asses daily activity, daily number of steps within 7 days prior to intervention, after intervention and after observation period.

Being tested
Respiratory training with the use of resistance set on respiratory muscle trainer, Respiratory training without resistance set on respiratory muscle trainer
Keywords
COVID-19, rehabilitation, respiratory training
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respiratory training with the use of resistance set on respiratory muscle trainerOther

    Performing respiratory training with resistance set on respiratory trainer.

  • Respiratory training without resistance set on respiratory muscle trainerOther

    Performing respiratory training with no resistance set on respiratory trainer

Study groups in NCT05449379
Study groupRoleWhat they receive
Post COVID experimental groupExperimentalSafe protocol of 6 week physical training (aerobic training, resistance training, general improvement training, stretching training and respiratory rehabilitation) adjusted to the clinical state of patients plus additional resistance respiratory training with the use of respiratory muscle trainer (Philips Respironics Threshold IMT).
Receives: Other: Respiratory training with the use of resistance set on respiratory muscle trainer
Post COVID control groupPlacebo comparatorSafe protocol of 6 week physical training (aerobic training, resistance training, general improvement training, stretching training and respiratory rehabilitation) adjusted to the clinical state of patients. No resistance set on respiratory muscle trainer (Philips Respironics Threshold IMT).
Receives: Other: Respiratory training without resistance set on respiratory muscle trainer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical endurance improvement assessment of 6 MWT distance and outcome of treadmill stress test.

    6-min walk test (6 MWT) is a exercise test that entails measurement of distance walked over a span of 6 minutes by patient good outcome > 500 m, bad outcome < 200 m.

    Treadmill stress test is performed with use of Bruce or ModBruce (modified Bruce) protocol, the outcome is measured in metabolic equivalents (METs) adjusted to the sex and age

    Measured: 6 months

  2. Evaluation of quality of life

    Quality of life measurement with SF36 (The Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health.The Optum™ SF-36v2® Health Survey asks 36 questions to measure functional health and wellbeing from the patient's point of view. It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes. The more number of points witness of better quality of life. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years. This bibliography includes studies of hundreds of diseases, conditions and populations, and greatly enhances the ability to interpret SF health survey data in new studies.Range 0-180 points

    Measured: 6 months

  3. Force of respiratory muscles

    Measurement of maximal inspiratory and expiratory pressure

    Measured: 6 months

Secondary outcomes (20)

  1. Spirometry

    Measurement of basic parameters as VC (vital capacity), FEV1 (forced expiratory volume in 1 second), FEV1/VC (forced expiratory volume in 1 second//vital capacity) ratio

    Measured: 6 months

  2. Force of quadriceps muscles

    Measurement the force of quadriceps muscles

    Measured: 6 months

  3. Handgrip strength

    Measurement of handgrip strength

    Measured: 6 months

  4. The Short Physical Performance Battery (SPPB)

    Series of tests used to evaluate lower extremity function and mobility including the gait speed, chair stand and balance tests. Range 0-12 points, 0-6 low performance, 10-12 high performance;

    Measured: 6 months

  5. Weight

    measurement of weight in kilograms

    Measured: 6 months

  6. Beck Depression Inventory (BDI)

    21-item, self-report rating inventory measuring characteristic attitudes and symptoms of depression. (Range 0-63 ponts, 0-11 points no depression, 50-63 points- severe depression)

    Measured: 6 months

  7. Hamilton Depression Scale (HAMD))

    Multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. (Range 0-50 ponts, 0-6points no depression, 25-50 points- severe depression)

    Measured: 6 months

  8. Post-COVID-19 Functional Status [PCFS] scale. Range 0-4 0- no limitation of daily functioning, 4 severe limitation of daily functioning

    Simple and rapid self-report scale allowing monitoring of the functional impact of the disease

    Measured: 6 months

  9. Modified Fatigue Impact Scale (MFIS).

    21-item scale measuring the impact of fatigue on a patient's daily life.Range 0-84 points. 0- no impact, 84 very severe impact

    Measured: 6 months

  10. Modified Medical Research Council (mMRC)

    Modified Medical Research Council (mMRC) most commonly used validated scale to assess dyspnea in daily living in chronic pulmonary diseases. Range 0-4, 0 grade dyspnea only with strenuous exercise, 4 patient too dyspneic to leave house or breathless when dressing

    Measured: 6 months

  11. Chest wall mobility

    Measurement of chest wall mobility at the level of the xiphoid process and the tenth rib

    Measured: 6 months

  12. Diaphragm ultrasound

    Measurement of diaphragm thickness in ultrasonography

    Measured: 6 months

  13. Modified Borg scale

    10 item scale describing dyspnea during daily activities (0- no dyspnea, 10 ver very severe dyspnea)

    Measured: 6 months

  14. Concentration of CRP

    Measurement of serum concentrations of CRP (C-reactive protein) mg/dl

    Measured: 6 months

  15. Concentration of Il-6

    Measurement of serum concentrations of interleukin 6 (IL-6) pg/ml

    Measured: 6 months

  16. Concentration of BDNF( brain-derived neurotrophic factor)

    Measurement of serum concentrations of BDNF ng/ml

    Measured: 6 months

  17. Concentration of adiponectin

    Measurement of serum concentrations adiponectin ug/ml

    Measured: 6 months

  18. Concentration of fibroblast growth factor 21 (FGF21)

    Measurement of serum concentrations of fibroblast growth factor 21 (FGF21) ng/ml

    Measured: 6 months

  19. Concentration of resistin

    Measurement of serum concentrations resistin ng/ml

    Measured: 6 months

  20. Concentration of myonectin

    Measurement of serum concentrations myonectin ng/ml

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start1 Jun 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05449379
Sponsor's protocol ID
SUB/1/DN/22/001/3309
Status last verified
Jul 2022
First submitted
7 Jul 2022
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.

    PubMed 32379637

  • Dun Y, Liu C, Ripley-Gonzalez JW, Liu P, Zhou N, Gong X, You B, Du Y, Liu J, Li B, Liu S. Six-month outcomes and effect of pulmonary rehabilitation among patients hospitalized with COVID-19: a retrospective cohort study. Ann Med. 2021 Dec;53(1):2099-2109. doi: 10.1080/07853890.2021.2001043.

    PubMed 34766857

  • Benzarti W, Toulgui E, Prefaut C, Chamari K, Ben Saad H. General practitioners should provide the cardiorespiratory rehabilitation' 'minimum advice' for long COVID-19 patients. Libyan J Med. 2022 Dec;17(1):2009101. doi: 10.1080/19932820.2021.2009101. No abstract available.

    PubMed 34839808

  • Yan H, Ouyang Y, Wang L, Luo X, Zhan Q. Effect of respiratory rehabilitation training on elderly patients with COVID-19: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Sep 11;99(37):e22109. doi: 10.1097/MD.0000000000022109.

    PubMed 32925755

  • Wang TJ, Chau B, Lui M, Lam GT, Lin N, Humbert S. Physical Medicine and Rehabilitation and Pulmonary Rehabilitation for COVID-19. Am J Phys Med Rehabil. 2020 Sep;99(9):769-774. doi: 10.1097/PHM.0000000000001505.

    PubMed 32541352

  • Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: interim guidance on rehabilitation in the hospital and post-hospital phase from a European Respiratory Society- and American Thoracic Society-coordinated international task force. Eur Respir J. 2020 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.

    PubMed 32817258

  • Cheng YY, Chen CM, Huang WC, Chiang SL, Hsieh PC, Lin KL, Chen YJ, Fu TC, Huang SC, Chen SY, Chen CH, Chen SM, Chen HS, Chou LW, Chou CL, Li MH, Tsai SW, Wang LY, Wang YL, Chou W. Rehabilitation programs for patients with COronaVIrus Disease 2019: consensus statements of Taiwan Academy of Cardiovascular and Pulmonary Rehabilitation. J Formos Med Assoc. 2021 Jan;120(1 Pt 1):83-92. doi: 10.1016/j.jfma.2020.08.015. Epub 2020 Aug 17.

    PubMed 32863084

  • Azoulay D, Shehadeh M, Chepa S, Shaoul E, Baroum M, Horowitz NA, Kaykov E. Recovery from SARS-CoV-2 infection is associated with serum BDNF restoration. J Infect. 2020 Sep;81(3):e79-e81. doi: 10.1016/j.jinf.2020.06.038. Epub 2020 Jun 20. No abstract available.

    PubMed 32569603

  • Ajaz S, McPhail MJ, Singh KK, Mujib S, Trovato FM, Napoli S, Agarwal K. Mitochondrial metabolic manipulation by SARS-CoV-2 in peripheral blood mononuclear cells of patients with COVID-19. Am J Physiol Cell Physiol. 2021 Jan 1;320(1):C57-C65. doi: 10.1152/ajpcell.00426.2020. Epub 2020 Nov 5.

    PubMed 33151090

  • Kearns SM, Ahern KW, Patrie JT, Horton WB, Harris TE, Kadl A. Reduced adiponectin levels in patients with COVID-19 acute respiratory failure: A case-control study. Physiol Rep. 2021 Apr;9(7):e14843. doi: 10.14814/phy2.14843.

    PubMed 33904656

  • Fukushima A, Kinugawa S, Homma T, Masaki Y, Furihata T, Yokota T, Matsushima S, Abe T, Suga T, Takada S, Kadoguchi T, Katsuyama R, Oba K, Okita K, Tsutsui H. Decreased serum brain-derived neurotrophic factor levels are correlated with exercise intolerance in patients with heart failure. Int J Cardiol. 2013 Oct 12;168(5):e142-4. doi: 10.1016/j.ijcard.2013.08.073. Epub 2013 Aug 27. No abstract available.

    PubMed 24029660

  • Kirwan R, McCullough D, Butler T, Perez de Heredia F, Davies IG, Stewart C. Sarcopenia during COVID-19 lockdown restrictions: long-term health effects of short-term muscle loss. Geroscience. 2020 Dec;42(6):1547-1578. doi: 10.1007/s11357-020-00272-3. Epub 2020 Oct 1.

    PubMed 33001410

  • Sagarra-Romero L, Vinas-Barros A. COVID-19: Short and Long-Term Effects of Hospitalization on Muscular Weakness in the Elderly. Int J Environ Res Public Health. 2020 Nov 24;17(23):8715. doi: 10.3390/ijerph17238715.

    PubMed 33255233

  • Nobari H, Fashi M, Eskandari A, Perez-Gomez J, Suzuki K. Potential Improvement in Rehabilitation Quality of 2019 Novel Coronavirus by Isometric Training System; Is There "Muscle-Lung Cross-Talk"? Int J Environ Res Public Health. 2021 Jun 10;18(12):6304. doi: 10.3390/ijerph18126304.

    PubMed 34200791

  • Pietranis KA, Kuryliszyn-Moskal A, Moskal-Jasinska D, Wojciuk M, Ciolkiewicz M, Kaniewska K. Effectiveness of comprehensive rehabilitation for functional recovery and symptom reduction in long COVID: results from a six-month randomised controlled trial. Sci Rep. 2026 May 5;16(1):20662. doi: 10.1038/s41598-026-51787-2.

    PubMed 42086796

Questions about this trial

What is this clinical trial studying?

A study testing Respiratory training with the use of resistance set on respiratory muscle trainer and Respiratory training without resistance set on respiratory muscle trainer in people with COVID-19 and Rehabilitation, run by Medical University of Bialystok at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mariusz Ciolkiewicz, PhD (858318315 ext. 0048, mariusz.ciolkiewicz@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical endurance improvement assessment of 6 MWT distance and outcome of treadmill stress test. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05449379, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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