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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor

Intervention / Treatment
-----------------
* Other: Inspiratory muscle training group
* Other: Inspiratory muscle training placebo group
* Other: Inspiratory + expiratory muscle training group
* Other: Inspiratory + expiratory muscle training placebo group


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind randomized controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle training group<br>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<br>* Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.<br>|
| Sham Comparator: Inspiratory muscle training placebo group<br>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<br>* Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.<br>|
| Experimental: Inspiratory + expiratory muscle training group<br>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<br>* Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.<br>|
| Sham Comparator: Inspiratory + expiratory muscle training placebo group<br>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<br>* Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from Baseline Exercise tolerance at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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. | 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. | 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. | 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. | Change from Baseline Psychological factors at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Respiratory Muscle Training, Respiratory Function Test, Quality of Life, Psychosocial Factor