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

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ClinicalTrials.gov Identifier: NCT04734561
Recruitment Status : Completed
First Posted : February 2, 2021
Last Update Posted : September 30, 2021
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Respiratory Muscle Training Respiratory Function Test Quality of Life Psychosocial Factor Other: Inspiratory muscle training group Other: Inspiratory muscle training placebo group Other: Inspiratory + expiratory muscle training group Other: Inspiratory + expiratory muscle training placebo group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 8, 2021
Actual Primary Completion Date : July 31, 2021
Actual Study Completion Date : September 29, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Inspiratory muscle training group
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
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.
 Other: Inspiratory muscle training placebo group
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734561


Locations
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Spain
UComplutenseMadrid
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Complutense de Madrid
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain
Investigators
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Principal Investigator: Ibai López de Uralde Villanueva, PhD Universidad Complutense de Madrid
More Information
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Publications:

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Responsible Party: Ibai López de Uralde Villanueva, Professor Ibai López de Uralde Villanueva, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04734561    
Other Study ID Numbers: 20/715-E_BS
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ibai López de Uralde Villanueva, Universidad Complutense de Madrid:
COVID-19
Respiratory Muscle Training
Respiratory Function Test
Quality of Life
Psychosocial Factor
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases