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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734561
• Other study ID #: 20/715-E_BS
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: September 29, 2021

Study information

• Verified date: September 2021
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 29, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Psychosocial Factor
• Quality of Life
• Respiratory Function Test
• Respiratory Muscle Training

Intervention

Other:
• Inspiratory muscle training group
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
• Inspiratory muscle training placebo group
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
• Inspiratory + expiratory muscle training group
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
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.

Locations

Country	Name	City	State
Spain	UComplutenseMadrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View Citation

Jiménez-Pavón 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. Review. — View 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. — View 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 Aug 13. pii: 2002197. doi: 10.1183/13993003.02197-2020. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Maximum respiratory pressures	The maximum respiratory pressures (MIP and MEP) will be measure with a device. This device applies an inspiratory/expiratory load which provides a resistance. The maneuver will be perform in a sitting position. Measuring a minimum of 3 times will be perform, recording the highest value.	Change from Baseline Maximum respiratory pressures at 8 weeks
Secondary	Inspiratory muscle endurance	To measure inspiratory muscle endurance, The subjects inspire from a threshold valve beginning with pressures of 30% of MIP. The threshold pressure is then increased 10% of MIP until the load cannot be tolerated for 2 minutes. The maximum inspiratory mouth pressure that can be tolerated for the full 2-minute interval is considered the peak pressure (Ppeak)	Change from Baseline Inspiratory muscle endurance at 8 weeks
Secondary	Upper limb muscle strength	To measure peripheral muscle strength the isometric strength of the hand and forearm will be evaluated through a valid and reliable tool. Three separate tests will be administered for each arm and the highest value in kilograms will be recorded.	Change from Baseline Peripheral muscle strength at 8 weeks
Secondary	Lung function (forced spirometry)	The Spirometry will be perform according to American Thoracic Society criteria and was measured in liters. The maneuver will be perform 3 times and recording the best one.	Change from Baseline Lung function at 8 weeks
Secondary	Cognitive factors	A validated cognitive scale will be assessed in all study participants with acceptable psychometric properties to evaluate cognitive factors. Unit of Measure: Units on a Scale where higher values represent a greater impact.	Change from Baseline cognitive factors at 8 weeks
Secondary	Lower limb muscle strength	A practical, reliable and valid field test consisted on to complete as many sit-to-stand cycles as possible on a chair during a frame time.	Change from Baseline Lower limb strength at 8 weeks
Secondary	Psychological factors	A validated anxiety, depression and stress scale will be assessed in all study participants with acceptable psychometric properties to evaluate anxiety and stress factors. Unit of Measure: Units on a Scale where higher values represent a greater impact. These measurements will be aggregated to arrive at one reported value of the impact of Psychological factors.	Change from Baseline Psychological factors at 8 weeks