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

• ClinicalTrials.gov Identifier: NCT04734561
• Recruitment Status: Completed
• First Posted: February 2, 2021
• Last Update Posted: September 30, 2021
• Sponsor: Universidad Complutense de Madrid
• Collaborator: Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain
• Information provided by (Responsible Party): Ibai López de Uralde Villanueva, Universidad Complutense de Madrid

Tracking Information

• First Submitted Date: December 31, 2020
• First Posted Date: February 2, 2021
• Last Update Posted Date: September 30, 2021
• Actual Study Start Date: February 8, 2021
• Actual Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2021)

• Health-related quality of life [ Time Frame: Change from Baseline Health-related quality of life at 8 weeks ]
  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.
• Exercise tolerance [ Time Frame: Change from Baseline Exercise tolerance at 8 weeks ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 30, 2021)

• Maximum respiratory pressures [ Time Frame: Change from Baseline Maximum respiratory pressures at 8 weeks ]
  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.
• Inspiratory muscle endurance [ Time Frame: Change from Baseline Inspiratory muscle endurance at 8 weeks ]
  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)
• Upper limb muscle strength [ Time Frame: Change from Baseline Peripheral muscle strength at 8 weeks ]
  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.
• Lung function (forced spirometry) [ Time Frame: Change from Baseline Lung function at 8 weeks ]
  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.
• Cognitive factors [ Time Frame: Change from Baseline cognitive factors at 8 weeks ]
  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.
• Lower limb muscle strength [ Time Frame: Change from Baseline Lower limb strength at 8 weeks ]
  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.
• Psychological factors [ Time Frame: Change from Baseline Psychological factors at 8 weeks ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

double-blind randomized controlled clinical trial

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Condition

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

Intervention

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

Study Arms

• Experimental: Inspiratory muscle training group
  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.
  Intervention: Other: Inspiratory muscle training group
• Sham Comparator: Inspiratory muscle training placebo group
  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.
  Intervention: Other: Inspiratory muscle training placebo group
• Experimental: Inspiratory + expiratory muscle training group
  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.
  Intervention: Other: Inspiratory + expiratory muscle training group
• Sham Comparator: Inspiratory + expiratory muscle training placebo group
  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.
  Intervention: Other: Inspiratory + expiratory muscle training placebo group

Publications *

• 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.
• 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.
• 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;56(6):2002197. doi: 10.1183/13993003.02197-2020. Online ahead of print.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 30, 2021): 88
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 29, 2021
• Actual Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04734561
• Other Study ID Numbers: 20/715-E_BS
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ibai López de Uralde Villanueva, Universidad Complutense de Madrid
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Complutense de Madrid
• Original Study Sponsor: Same as current
• Collaborators: Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain

Investigators

• Principal Investigator: Ibai López de Uralde Villanueva, PhD; Universidad Complutense de Madrid

• PRS Account: Universidad Complutense de Madrid
• Verification Date: September 2021