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

NCT05449379 | Unknown

• 1 other identifier: SUB/1/DN/22/001/3309
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; Rehabilitation

Keywords

COVID-19; rehabilitation; respiratory training

Outcome Measures

Primary Outcomes (3)

• 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

  6 months

• 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

  6 months

• Force of respiratory muscles

  Measurement of maximal inspiratory and expiratory pressure

  6 months

Secondary Outcomes (20)

• Spirometry

  6 months

• Force of quadriceps muscles

  6 months

• Handgrip strength

  6 months

• The Short Physical Performance Battery (SPPB)

  6 months

• Weight

  6 months

Study Arms (2)

Post COVID experimental group

EXPERIMENTAL

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 plus additional resistance respiratory training with the use of respiratory muscle trainer (Philips Respironics Threshold IMT).

Other: Respiratory training with the use of resistance set on respiratory muscle trainer

Post COVID control group

PLACEBO COMPARATOR

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. No resistance set on respiratory muscle trainer (Philips Respironics Threshold IMT).

Other: Respiratory training without resistance set on respiratory muscle trainer

Interventions

Respiratory training with the use of resistance set on respiratory muscle trainer OTHER

Performing respiratory training with resistance set on respiratory trainer.

Post COVID experimental group

Respiratory training without resistance set on respiratory muscle trainer OTHER

Performing respiratory training with no resistance set on respiratory trainer

Post COVID control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• syncope
• worsening oedema of extremities
• myocarditis (less than 6 months from acute phase)

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Medical University of Bialystok, Department of Rehabilitation

Bialystok, Podlaskie Voivodeship, 15-089, Poland

RECRUITING

Related Publications (14)

• 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.

  PMID: 32379637 BACKGROUND

• 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.

  PMID: 34766857 BACKGROUND

• 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.

  PMID: 34839808 BACKGROUND

• 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.

  PMID: 32925755 BACKGROUND

• 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.

  PMID: 32541352 BACKGROUND

• 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.

  PMID: 32817258 BACKGROUND

• 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.

  PMID: 32863084 BACKGROUND

• 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.

  PMID: 32569603 BACKGROUND

• 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.

  PMID: 33151090 BACKGROUND

• 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.

  PMID: 33904656 BACKGROUND

• 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.

  PMID: 24029660 BACKGROUND

• 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.

  PMID: 33001410 BACKGROUND

• 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.

  PMID: 33255233 BACKGROUND

• 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.

  PMID: 34200791 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anna Kuryliszyn-Moskal, Professor

  Medical University of Bialystok

  STUDY CHAIR

Central Study Contacts

Mariusz Ciolkiewicz, PhD

CONTACT

858318315; mariusz.ciolkiewicz@umb.edu.pl

Mariusz Wojciuk, PhD

CONTACT

858318315; mariusz.wojciuk@umb.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 8, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)