Covid19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor
Conditions
Keywords
COVID-19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor
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.
Interventions
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
OTHERInspiratory muscle training placebo group
Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
OTHERInspiratory + expiratory muscle training placebo group
Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
Sponsors
Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
double-blind randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Upper limb muscle strength | 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) | 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. |
| Maximum respiratory pressures | 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. |
| Lower limb muscle strength | 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 | 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. |
| Cognitive factors | 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. |
| Inspiratory muscle endurance | 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) |
Countries
Spain
Outcome results
None listed