Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease

NCT04734561 | Completed

• 1 other identifier: 20/715-E_BS
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the present study is to observe the short-term effects of respiratory muscle training applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. As secondary objectives, the effects on respiratory muscles strength/tolerance, pulmonary function and psychological and cognitive factors.

Conditions

Covid19; Respiratory Muscle Training; Respiratory Function Test; Quality of Life; Psychosocial Factor

Keywords

COVID-19; Respiratory Muscle Training; Respiratory Function Test; Quality of Life; Psychosocial Factor

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life

  To evaluate the health-related quality of life of the participants a valid, reliable and generic questionnaire will be used. It consisted of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.

  Change from Baseline Health-related quality of life at 8 weeks

• Exercise tolerance

  Exercise tolerance will be evaluated by a test consisted on 30 squats based on three different heart rate measuring moments (resting heart rate, heart rate after exercise, heart rate after longer period) evaluating the speed at which the heart rate increases/decreases.

  Change from Baseline Exercise tolerance at 8 weeks

Secondary Outcomes (7)

• Maximum respiratory pressures

  Change from Baseline Maximum respiratory pressures at 8 weeks

• Inspiratory muscle endurance

  Change from Baseline Inspiratory muscle endurance at 8 weeks

• Upper limb muscle strength

  Change from Baseline Peripheral muscle strength at 8 weeks

• Lung function (forced spirometry)

  Change from Baseline Lung function at 8 weeks

• Cognitive factors

  Change from Baseline cognitive factors at 8 weeks

Study Arms (4)

Inspiratory muscle training group

EXPERIMENTAL

Participants will perform an inspiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Other: Inspiratory muscle training group

Inspiratory muscle training placebo group

SHAM COMPARATOR

Participants will perform an inspiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Other: Inspiratory muscle training placebo group

Inspiratory + expiratory muscle training group

EXPERIMENTAL

Participants will perform an inspiratory and expiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Other: Inspiratory + expiratory muscle training group

Inspiratory + expiratory muscle training placebo group

SHAM COMPARATOR

Participants will perform an inspiratory and expiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.

Other: Inspiratory + expiratory muscle training placebo group

Interventions

Inspiratory muscle training group OTHER

Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.

Inspiratory muscle training group

Inspiratory muscle training placebo group OTHER

Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.

Inspiratory muscle training placebo group

Inspiratory + expiratory muscle training group OTHER

Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.

Inspiratory + expiratory muscle training group

Inspiratory + expiratory muscle training placebo group OTHER

Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.

Inspiratory + expiratory muscle training placebo group

Eligibility Criteria

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

You may qualify if:

• Positive diagnosis of COVID-19 (SARS-CoV2)
• Hospital admission for COVID-19 in the last 3 months
• Stable phase and home discharge;

You may not qualify if:

• Severe cognitive impairment
• Any type of musculoskeletal, neurological, cardiac or respiratory disease where training is contraindicated
• Inability to carry out the training program through telematic supervision.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain: collaborator

Study Sites (1)

UComplutenseMadrid

Madrid, 28040, Spain

Location

Related Publications (5)

• Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847.

  PMID: 32675661 BACKGROUND

• Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.

  PMID: 32475821 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

• Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.

  PMID: 32220590 BACKGROUND

• 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

MeSH Terms

Conditions

COVID-19

Interventions

Inhalation

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

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ibai López de Uralde Villanueva, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ibai López de Uralde Villanueva

Model Details: double-blind randomized controlled clinical trial

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: February 2, 2021
• Study Start: February 8, 2021
• Primary Completion: July 31, 2021
• Study Completion: September 29, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

ES (1)