Exercise for Health in Patients With Post-acute Sequelae of COVID-19

NCT05848518 | Completed

• 1 other identifier: CampusSantJoan
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Many patients with COVID-19 present the so-called post-acute sequelae of COVID-19 such as fatigue, post-stress discomfort, dyspnea, headache, pain mental impairment, incapacity to perform daily physical tasks ant exercise intolerance. This study aims to investigate the effects of different exercise programs on physical and mental fitness, physical condition and biomarkers of the immune system and oxidative stress in older COVID-19 survivors. Methods: The sample will be made up of 120 eligible participants, over the age of 60 years who have had COVID-19 disease and are survivors and present persistent COVID-19 symptomatology diagnosed by the corresponding physician. The participants will be randomly assigned to the experimental groups: supervised endurance group (SEG, n = 30), supervised strength group (SSG, n = 30), supervised concurrent group (SCG, n = 30), which will perform the corresponding exercise program 3 days a week compared to the control group (CG, n = 30), which will not carry out a supervised exercise program. The design of this project will include assessment of cardiorespiratory fitness, muscle fitness, pain and mental health, and biomarkers of inflammation and oxidative stress.

Conditions

Long COVID

Keywords

rehabilitation programs; endurance exercise; resistance exercise; cardiopulmonary exercise testing; muscle strength assessment; quality of life; elderly people; severe acute respiratory syndrome coronavirus 2

Outcome Measures

Primary Outcomes (33)

• Cardiorespiratory fitness: absolute oxygen uptake

  absolute oxygen uptake (peak VO2) in L/min

  1 week per group

• Cardiorespiratory fitness: relative oxygen uptake

  relative oxygen uptake (peak VO2) in mL/kg/min

  1 week per group

• Cardiorespiratory fitness: ventilation

  minute ventilation (VE) in L/min.

  1 week per group

• Cardiorespiratory fitness: ventilatory equivalent for oxygen

  Ventilatory equivalent for oxygen (VE/VO2)

  1 week per group

• Cardiorespiratory fitness: ventilatory equivalent for carbon dioxide

  Ventilatory equivalent for carbon dioxide (VE/VCO2)

  1 week per group

• Cardiorespiratory fitness: respiratory exchange ratio

  Respiratory exchange ratio (RER)

  1 week per group

• Cardiorespiratory fitness: End-tidal partial pressure

  End-tidal partial pressure of oxygen and carbon dioxide (PetO2 and PetCO2, respectively) in mmHg.

  1 week per group

• Muscular fitness: Sit and stand test

  Sit and stand test for 30 seconds. The number of times in 30 seconds the participant can completely stand up from a seated position with the back straight and the feet on the floor without pushing with the arms will be counted.

  1 week per group

• Muscular fitness: countermovement jump

  Countermovement jumps: Flight Height in cm

  1 week per group

• Muscular fitness: countermovement test

  Countermovement jumps: power output of the lower extremities in watts

  1 week per group

• Muscular fitness: Upper limb strength

  This will be evaluated with the bicep curl test made with a 2 kg weight for women and a 4 Kg weight for men. The number of elbow curls made in 30 seconds with each upper limb will be counted.

  1 week per group

• Muscular fitness: hand grip strength

  Hand grip strength: Force in Newtons Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered

  1 week per group

• Muscular fitness: Motor Agility/Dynamic balance

  Motor Agility/Dynamic balance: This will be evaluated with the 8-foot up and go test. The best of two attempts will be registered in seconds

  1 week per group

• Muscular fitness: Isokinetic strength test

  The isokinetic knee flexor and extensor test: peak torque in N m

  1 week per group

• Muscular fitness: Isokinetic strength testing

  The isokinetic knee flexor and extensor test: power output in Watts

  1 week per group

• Body composition: fat mass

  Fat mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.

  1 week per group

• Body composition: fat free mass

  Fat free mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.

  1 week per group

• Body composition: muscle mass

  Muscle mass will be assessed by bioelectrical impedance analysis in kg and percentage of body weight.

  1 week per group

• Concentration of oxidative stress biomarkers: thiobarbituric acid reactive substances

  Determination of oxidized lipids by the thiobarbituric acid reactive substances (TBARS) in mmols (fluorimetry technique).

  1 week per group

• Concentration of oxidative stress biomarkers: Advanced Oxidation Protein Products

  Determination of oxidized proteins by the Advanced Oxidation Protein Products (AOPP) in nmol Cl-T/mg protein, (colorimetry technique)

  1 week per group

• Concentration of oxidative stress biomarkers: nitrites and nitrates

  Determination of nitrites and nitrates (colorimetry) in nmol/mL

  1 week per group

• Concentration of biomarkers of antioxidant enzymes: superoxide dismutase

  superoxide dismutase (SOD) in units/mL

  1 week per group

• Concentration of biomarkers of antioxidant enzymes: catalase

  catalase (CAT) in units/mL

  1 week per group

• Concentration of biomarkers of antioxidant enzymes: glutathion peroxidase

  Glutathion peroxidase (GPx) in units/mL.

  1 week per group

• Concentration of inflammation biomarkers: Interleukines

  Interleukin 6 and 10 (IL-6 and IL-10) in ng/mL

  1 week per group

• Concentration of inflammation biomarkers: adiponectin

  adiponectin in mg/L

  1 week per group

• Concentration of biomarkers of inflammation: Tumor necrosis factor

  Tumor Necrosis Factor-alpha in pg/mL

  1 week per group

• Evaluation of the degree of pain using the pupillometer: pupil diameter

  basal and maximum diameter of the pupil in mm

  1 week per group

• Evaluation of the degree of pain using the pupillometer:variation of pupil

  percentage of variation of pupil diameter in %

  1 week per group

• Evaluation of the degree of pain using the pupillometer: pupil variation

  variation of the pupil in mm

  1 week per group

• Evaluation of the degree of pain using the pupillometer: Intensity of reflex of dilatation

  Intensity of reflex of dilatation, latency.

  1 week per group

• Evaluation of the degree of pain with a pressure algometer: algometers

  Pain will be quantified with a pressure algometer + pupillometer in older COVID-19 survivors. A pressure algometer allows the application of a controlled and quantifiable nociceptive stimulus on a body surface. Algometers apply a pressure stimulus that can be useful for applying a standardized painful stimulus, having a different nature from that applied with the pupillometer which is a stimulus of electric origin.

  1 week per group

• Mental health

  Psychosocial variables will be evaluated using the Hospital Anxiety and Depression Scale (HADS), which is made up of 7 items for anxiety and depression. Each item of the anxiety subscale (HADS-A) and the depression subscale (HADS-D) will be scored on a scale of 4 points from 0 (none) to 3 (much more). The highest scores indicate the highest levels of anxiety or depression

  1 week per group

Study Arms (4)

Concurrent rehabilitation program

EXPERIMENTAL

Endurance plus resistance exercises

Other: Rehabilitation program

Endurance rehabilitation program

EXPERIMENTAL

Endurance exercises

Other: Rehabilitation program

Strength rehabilitation program

EXPERIMENTAL

Resistance exercises

Other: Rehabilitation program

Control group

NO INTERVENTION

No exercise

Interventions

Rehabilitation program OTHER

The participants will be randomly assigned to the experimental groups: supervised endurance rehabilitation program (SEG, n = 30), supervised strength rehabilitation program (SSG, n = 30), supervised concurrent rehabilitation program (SCG, n = 30), and control group (CG, n = 30)

Concurrent rehabilitation program; Endurance rehabilitation program; Strength rehabilitation program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons of both sexes (and different expression of gender) older than 60 years of age.
• No history of physical diseases and no disease or disability that limits participation in the exercise program or precludes the corresponding measurement/evaluations.
• Be able to communicate without difficulty.
• Be able to understand the objectives of the project and provide informed consent. In this case, the consent form will be signed.
• Not taking any medication that can affect normal performance of the exercise program and the evaluations

You may not qualify if:

• Having acute or terminal disease or any other disease that may affect the normal practice of a supervised exercise program and the corresponding evaluations.
• Consumption of alcohol or drugs.
• Be performing any type of activity that may interfere in carrying out the supervised exercise program or the evaluations.
• Not completing the study once initiated or wishing to participate in the control group.

Sponsors & Collaborators

• Campus docent Sant Joan de Déu-Universitat de Barcelona: lead
• Hospital de Mataró: collaborator
• University of Barcelona: collaborator

Study Sites (1)

Campus Docent Sant Joan de Déu. Universitat de Barcelona

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Related Publications (1)

• Pleguezuelos E, Sanchez-Nuno S, Del Carmen A, Serra-Paya N, Moreno E, Molina-Raya L, Robleda G, Benet M, Santos-Ruiz S, Garrido AB, Jerez-Molina C, Miravitlles M, Serra-Prat M, Vinals X, Farres MG, Carbonell T, Garnacho-Castano MV. Effect of different types of supervised exercise programs on cardiorespiratory and muscular fitness, pain, fatigue, mental health and inflammatory and oxidative stress biomarkers in older patients with post-COVID-19 sequelae "EJerSA-COVID-19": a randomized controlled trial. BMC Geriatr. 2023 Dec 15;23(1):865. doi: 10.1186/s12877-023-04544-3.

  PMID: 38102536 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Manuel V Garnacho-Castaño, PhD

  Campus docent Sant Joan de Déu-Universitat de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the DAFNiS research group

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 8, 2023
• Study Start: May 15, 2023
• Primary Completion: September 30, 2023
• Study Completion: January 31, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)