Clinical trial NCT04734561: Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease
Official title: Effects of Respiratory Muscle Training on Quality of Life, Physical and Pulmonary Function and Psychological Status in Patients Who Have Had COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain
First posted: 2021-02-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized controlled clinical trial
Primary purpose: TREATMENT

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.

Detailed description: It is a double-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training, 2) Placebo Inspiratory muscle training, 3) Inspiratory muscle training + Expiratory muscle training, 4) Placebo Inspiratory muscle training + Expiratory muscle training.

Each exercise training program will be applied twice per day 7 sessions per week during 8 weeks by a threshold device. The evening sessions will be supervised by a physiotherapist through a virtual platform.

Participants received baseline assessments at the beginning of the intervention, at the end of the 4th week, and post-intervention assessments at the end of the 8th week.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: Change from Baseline Health-related quality of life at 8 weeks
measure: Exercise tolerance
timeFrame: Change from Baseline Exercise tolerance at 8 weeks
Secondary outcomes:
measure: Maximum respiratory pressures
timeFrame: Change from Baseline Maximum respiratory pressures at 8 weeks
measure: Inspiratory muscle endurance
timeFrame: Change from Baseline Inspiratory muscle endurance at 8 weeks
measure: Upper limb muscle strength
timeFrame: Change from Baseline Peripheral muscle strength at 8 weeks
measure: Lung function (forced spirometry)
timeFrame: Change from Baseline Lung function at 8 weeks
measure: Cognitive factors
timeFrame: Change from Baseline cognitive factors at 8 weeks
measure: Lower limb muscle strength
timeFrame: Change from Baseline Lower limb strength at 8 weeks
measure: Psychological factors
timeFrame: Change from Baseline Psychological factors at 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: UComplutenseMadrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Ibai López de Uralde Villanueva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.