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Completed

NCT Number: NCT04734561

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Psychosocial Factor Quality of Life RNA Virus Infections Respiratory Function Test Respiratory Muscle Training Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UComplutenseMadrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 placebo group

Other

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

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 placebo group

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Colegio de Fisioterapeutas de la Comunidad de Madrid

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 2, 2021
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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