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

Universidad Complutense de Madrid88 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Covid19 Respiratory Muscle Training

Interventions

Inspiratory muscle training groupOTHER

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

Inspiratory muscle training placebo groupOTHER

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

Inspiratory + expiratory muscle training groupOTHER

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

Inspiratory + expiratory muscle training placebo groupOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline Health-related quality of life at 8 weeks

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.

Time frame: Change from Baseline Exercise tolerance at 8 weeks

Secondary Outcomes

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.

Time frame: Change from Baseline Maximum respiratory pressures at 8 weeks

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)

Time frame: Change from Baseline Inspiratory muscle endurance at 8 weeks

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.

Time frame: Change from Baseline Peripheral muscle strength at 8 weeks

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.

Time frame: Change from Baseline Lung function at 8 weeks

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.

Time frame: Change from Baseline cognitive factors at 8 weeks

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.

Time frame: Change from Baseline Lower limb strength at 8 weeks

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.

Time frame: Change from Baseline Psychological factors at 8 weeks