The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Triflow Use of Triflow device and exercise regime |
Other: Triflow
Triflow
Other Names:
|
| Active Comparator: Control Only exercise regime |
Other: Control
Exercise
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Barthel Index [on admission day]
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.
- Barthel Index [on discharge day]
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.
- Dyspnoea (Medical Research Council Dyspnoea Scale) [on admission day]
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
- Dyspnoea (Medical Research Council Dyspnoea Scale) [on discharge day]
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
- Peak Flow Meter [on admission day]
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
- Peak Flow Meter [on discharge day]
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
Secondary Outcome Measures
- Number of hospitalisation days [on discharge day]
Number of days participants stay in the rehabilitation center
- Muscle strength (Hand Grip) [on admission day]
Assess muscle strength for the upper extremities via hand-held dynamometer
- Muscle strength (Hand Grip) [on discharge day]
Assess muscle strength for the upper extremities via hand-held dynamometer
- Muscle strength and endurance (30 seconds Sit to stand) [on admission day]
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
- Muscle strength and endurance (30 seconds Sit to stand) [on discharge day]
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
- Balance (Berg Balance) [on admission day]
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.
- Balance (Berg Balance) [on discharge day]
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.
- Cardiorespiratory fitness (Six minutes walking test) [on admission day]
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.
- Cardiorespiratory fitness (Six minutes walking test) [on discharge day]
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.
- Quality of life (EQ-5D-5L) [on admission day]
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)
- Quality of life (EQ-5D-5L) [on discharge day]
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)
- Fatigue (Multidimensional fatigue inventory) [on admission day]
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)
- Fatigue (Multidimensional fatigue inventory) [on discharge day]
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)
- Timed up and Go [on admission day]
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
- Timed up and Go [on discharge day]
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults who were infected with COVID-19 in the last 6 months and were diagnosed with long-covid syndrome
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Patients must be willing to give written consent for participation in the study
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Negative rapid test for COVID-19
Exclusion Criteria:
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History of diseases that do not allow exercise (e.g. unstable cardiac disease)
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Age < 18 years of age
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Significant cognitive and psychiatric impairments (inability to follow simple commands or give consent)
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Lack of will to do the exercises or refuse to give consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eden Resort Wellness Rehabilitation Center | Larnaca | Cyprus | 7562 |
Sponsors and Collaborators
- European University Cyprus
- Eden Resort Wellness Rehabilitation Center
Investigators
- Principal Investigator: Marina Kloni, European University Cyprus
Study Documents (Full-Text)
None provided.More Information
Publications
- Basoglu OK, Atasever A, Bacakoglu F. The efficacy of incentive spirometry in patients with COPD. Respirology. 2005 Jun;10(3):349-53. doi: 10.1111/j.1440-1843.2005.00716.x.
- Eltorai AEM, Szabo AL, Antoci V Jr, Ventetuolo CE, Elias JA, Daniels AH, Hess DR. Clinical Effectiveness of Incentive Spirometry for the Prevention of Postoperative Pulmonary Complications. Respir Care. 2018 Mar;63(3):347-352. doi: 10.4187/respcare.05679. Epub 2017 Dec 26.
- Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2022 Jul 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/
- Imamura M, Mirisola AR, Ribeiro FQ, De Pretto LR, Alfieri FM, Delgado VR, Battistella LR. Rehabilitation of patients after COVID-19 recovery: An experience at the Physical and Rehabilitation Medicine Institute and Lucy Montoro Rehabilitation Institute. Clinics (Sao Paulo). 2021 Jun 14;76:e2804. doi: 10.6061/clinics/2021/e2804. eCollection 2021.
- Mohamed AA, Alawna M. Role of increasing the aerobic capacity on improving the function of immune and respiratory systems in patients with coronavirus (COVID-19): A review. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):489-496. doi: 10.1016/j.dsx.2020.04.038. Epub 2020 Apr 28.
- Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
- Seyller H, Gottlieb M, Colla J. A breath of fresh air: The role of incentive spirometry in the treatment of COVID-19. Am J Emerg Med. 2021 Oct;48:369. doi: 10.1016/j.ajem.2021.01.084. Epub 2021 Feb 1. No abstract available.
- Siddiq MAB, Rathore FA, Clegg D, Rasker JJ. Pulmonary Rehabilitation in COVID-19 patients: A scoping review of current practice and its application during the pandemic. Turk J Phys Med Rehabil. 2020 Nov 9;66(4):480-494. doi: 10.5606/tftrd.2020.6889. eCollection 2020 Dec.
- Spielmanns M, Pekacka-Egli AM, Schoendorf S, Windisch W, Hermann M. Effects of a Comprehensive Pulmonary Rehabilitation in Severe Post-COVID-19 Patients. Int J Environ Res Public Health. 2021 Mar 7;18(5):2695. doi: 10.3390/ijerph18052695.
- Toor H, Kashyap S, Yau A, Simoni M, Farr S, Savla P, Kounang R, Miulli DE. Efficacy of Incentive Spirometer in Increasing Maximum Inspiratory Volume in an Out-Patient Setting. Cureus. 2021 Oct 4;13(10):e18483. doi: 10.7759/cureus.18483. eCollection 2021 Oct.
- Zampogna E, Paneroni M, Belli S, Aliani M, Gandolfo A, Visca D, Bellanti MT, Ambrosino N, Vitacca M. Pulmonary Rehabilitation in Patients Recovering from COVID-19. Respiration. 2021;100(5):416-422. doi: 10.1159/000514387. Epub 2021 Mar 30.
- Triflow