Physiotherapy for Persistent COVID-19 Disease Using Aerobic Exercise

NCT05453188 | Completed

• 1 other identifier: URJCLactate
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aerobic exercise - Nordic walking in Persistent Covid (PC) vs. healthy controls. The main objective of this study is to analyse the genes associated with increased physical performance in patients with PC vs. healthy controls and to measure the level of lactic acid in blood, pre and post exercise session in patients affected by PC. Relevance: It is intended to be a tool for patients with CP who have not been hospitalised, nor have been offered outpatient rehabilitation treatment. They have not recovered their work, family, sporting or leisure functions. They have particular problems in returning to aerobic exercise. We think that they may need to be accompanied in the recovery of their physical condition under the supervision of health professionals. Most of the studies offered to them are exploratory, not intervention. Our proposal is a 12-week intervention. Our proposal, delves into the mechanisms that may underlie their fatigue and their problems in returning to aerobic exercise, in order to collaborate in approaching possible solutions. Secondary objectives: To study in each of the patients with persistent covid, included in the aerobic Nordic walking programme, their DNA in order to, based on two candidate genes, analyse the role of genetic polymorphisms associated with increased VO2 max training, compared to a healthy control group. To assess the blood lactic acid level pre and post exercise in a group of patients with persistent covid pre and post aerobic Nordic walking programme. Patients and Methods: 33 patients with CP and 33 healthy controls will follow a Nordic walking programme for 12 weeks. QIAGEN Cube automatic extractor and lactic acid meter will be used.

Conditions

COVID-19; Genetic Predisposition to Disease

Keywords

longCOVID; Aerobic exercise; Muscle performance; Genetics

Outcome Measures

Primary Outcomes (4)

• Lactic acid concentration

  A small blood sample (0.3 microlitres) will be taken from the participant, by puncturing the index finger of the hand, to perform a blood lactate analysis. Pre-exercise and immediately after the physical activity

  Changes from baseline and at the end of procedure (12 weeks)

• EuroQoL Quality of Life Scale (EQ5D)

  The EuroQoL Quality of Life Scale (EQ5D) is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time

  Changes from baseline and at the end of procedure (12 weeks)

• 36-Item Short Form Survey (SF-36)

  The 36-Item Short Form Survey (SF-36) is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. SF-36 scale is directly transformed into a 0-100 on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  Changes from baseline and at the end of procedure (12 weeks)

• Modified Fatigue Impact Scale (MFIS)

  The Modified Fatigue Impact Scale (MFIS) is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives.The total score of the MFIS ranges from 0 to 84. The ranges of scores for each subscale are as follows: physical, 0 to 36; cognitive, 0 to 40; and psychosocial, 0 to 8. A higher score means fatigue is more significantly affecting patient´s life.

  Changes from baseline and at the end of procedure (12 weeks)

Secondary Outcomes (8)

• Genotype frequency of ACE polymorphism

  Baseline

• Genotype frequency of ACTN3 polymorphism

  Baseline

• Genotype frequency of AMPD1 polymorphism

  Baseline

• Genotype frequency of CKM polymorphism

  Baseline

• Genotype frequency of MLCK c.49C>T polymorphism

  Baseline

Study Arms (2)

LongCOVID

EXPERIMENTAL

Patients who have had COVID-19 and have been diagnosed with longCOVID or persistent COVID

Device: Experimental; Genetic: Control

Control

ACTIVE COMPARATOR

Patients who have had COVID-19, but have not been diagnosed with longCOVID or persistent COVID

Device: Experimental; Genetic: Control

Interventions

Experimental DEVICE

Pre- and post-intervention measurement of quality of life, self-perceived fatigue and blood lactic acid concentration after each Nordic Walking session.

Also known as: Lactic acid, EuroQool EQ5D, SF-36, MFIS

Control; LongCOVID

Control GENETIC

Genetic polymorphism study by Polymerase Chain Reaction (PCR) to determine genetic profile and allele frequencies of patients with persistent COVID and association by Total Genotype Score (TGS) with fatigue status.

Also known as: ACE polimorphism, ACTN3 polymorphism, AMPD1 polymorphism, CKM polymorphism, MLCK polymorphisms, ACE2 polymorphisms

Control; LongCOVID

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Persistent symptoms of covid for more than one year.
• Age between 30 and 60 years.
• Complete vaccination schedule (one dose is sufficient, as this was considered by the Ministry for patients who have passed the disease).
• Recent basic blood test.

You may not qualify if:

• Presence of comorbidities of musculoskeletal origin that contraindicate the practice of the proposed exercise.
• Presence of uncontrolled cardiac or respiratory disease.
• Presence of incapacitating neurological disease that significantly interferes with the proposed exercise activity Severe anaemia or other co-morbidities that significantly interfere with the proposed exercise activity
• Diagnosis or symptoms of dysautonomia
• Presence of high rates of fatigue
• Desaturations during the exercise test that imply a need for oxygen supply for exercise
• Desaturation on exertion during exercise ≥3%.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

David Varillas Delgado

Pozuelo de Alarcón, Madrid, 28224, Spain

Location

MeSH Terms

Conditions

COVID-19; Genetic Predisposition to Disease

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; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Varillas Delgado, PhD

  Universidad Francisco de Vitoria, crta Pozuelo-Majadahonda km 1.800 PC 28223, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 12, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 14, 2023

Record last verified: 2022-07

Locations

ES (1)