The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome

Study Overview
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Brief Summary
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The aim of this clinical trial is to investigate the efficacy of Triflow in the rehabilitation of patients with long covid syndrome hospitalised in a rehabilitation center. Participants will be divided into 2 groups and follow their exercise regime until the day they are discharged from the rehabilitation center. The intervention group will participate in a rehabilitation program which includes upper and lower limbs exercises, cycle ergometer, walking and the use of triflow. The control group will participate in the same program but without the Triflow.

Detailed Description
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Randomised controlled trial with 2 groups:Triflow and exercises (intervention) and exercises (control) Exercises:Exercises in the bed, chair and standing with/without weights, walking, cycle ergometer, treadmill. Triflow: 10 breaths in and 10 breaths out. Both groups will have 1 physiotherapy session per day for 6 days per week from admission to discharge. Sample size:The sample size is 70. We took into consideration the efficacy of completing the recruitment of patients in time. There few published studies with the use of Triflow as their primary intervention with smaller sample sizes. Population: Adults with long covid hospitalised in the rehabilitation center Statistical Analysis: will be done through IBM SPSS Statistics 20 and the level of statistical significance will be (p < 0.05). From the literature and international guidelines, physiotherapy should be offered to people hospitalized with long-COVID, without any serious risks and offering significant benefit.

Official Title
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The Use of Incentive Spirometry (Triflow) in Patients With Long Covid

Conditions
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Long COVID

Intervention / Treatment
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* Other: Triflow
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who were infected with COVID-19 in the last 6 months and were diagnosed with long-covid syndrome Patients must be willing to give written consent for participation in the study Negative rapid test for COVID-19 Exclusion Criteria: History of diseases that do not allow exercise (e.g. unstable cardiac disease) Age < 18 years of age Significant cognitive and psychiatric impairments (inability to follow simple commands or give consent) Lack of will to do the exercises or refuse to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triflow<br>Use of Triflow device and exercise regime | Other: Triflow<br>* Triflow<br>* Other names: Triflow and exercise regime;|
| Active Comparator: Control<br>Only exercise regime | Other: Control<br>* Exercise<br>* Other names: Exercise regime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living. | on admission day | 
| Barthel Index | Measures performance in activities of daily living (eg.stairs, dressing/undressing, washing,eating). Score from 0 to 100, where 0 indicates total dependence and 100 total independence with activities of daily living. | on discharge day | 
| Dyspnoea (Medical Research Council Dyspnoea Scale) | Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is | on admission day | 
| Dyspnoea (Medical Research Council Dyspnoea Scale) | Assess dyspnoea via MRC dyspnoea scale. The participants grade their dyspnoea on a scale of 1 to 5. The bigger the number, the worse their dyspnoea is | on discharge day | 
| Peak Flow Meter | Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is | on admission day | 
| Peak Flow Meter | Assess the respiratory function via peak flow meter. The participants will take a deep breath and blow the air out into the peak flow meter. The higher the score the better their respiratory function is | on discharge day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalisation days | Number of days participants stay in the rehabilitation center | on discharge day | 
| Muscle strength (Hand Grip) | Assess muscle strength for the upper extremities via hand-held dynamometer | on admission day | 
| Muscle strength (Hand Grip) | Assess muscle strength for the upper extremities via hand-held dynamometer | on discharge day | 
| Muscle strength and endurance (30 seconds Sit to stand) | Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance | on admission day | 
| Muscle strength and endurance (30 seconds Sit to stand) | Assess muscle strength for the lower extremities and endurance via 30 seconds sit to stand. The participants will have to stand up from a chair without using their arms as many times as they can in 30 seconds. The more times the better their muscle strength and endurance | on discharge day | 
| Balance (Berg Balance) | Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls. | on admission day | 
| Balance (Berg Balance) | Assess via Berg Balance Questionnaire, a total of 14 items that asess balance. from 0 to 56, the higher the score the better balance a person has and has a smaller risk for falls. | on discharge day | 
| Cardiorespiratory fitness (Six minutes walking test) | Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness. | on admission day | 
| Cardiorespiratory fitness (Six minutes walking test) | Assess the cardiorespiratory fitness via 6 minutes walking test. The participants have to walk for 6 mins independently and the distance they cover is measured. The bigger the distance the better cardiorespiratory fitness. | on discharge day | 
| Quality of life (EQ-5D-5L) | Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health) | on admission day | 
| Quality of life (EQ-5D-5L) | Assess via EQ-5D-5L questionnaire, it has 6 components (movement,self-care, everyday activities, pain/discomfort, stress/depression, and a scale from 0 to 100 for participants to score how they perceive their health on the day( 0 indicates worst heath and 100 best health) | on discharge day | 
| Fatigue (Multidimensional fatigue inventory) | Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true) | on admission day | 
| Fatigue (Multidimensional fatigue inventory) | Assess the feeling of fatigue via Multidimensional fatigue inventory. it has 20 questions with a scale from 1(yes that is true) to 5 (no that is not true) | on discharge day | 
| Timed up and Go | Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility | on admission day | 
| Timed up and Go | Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility | on discharge day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triflow, Incentive Spirometry, Long-covid