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

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813873
• Other study ID #: Triflow
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: European University Cyprus
• Contact: Marina E Kloni
• Phone: 0035799007245
• Email: marina.eleni[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Long COVID

Intervention

Other:
• Triflow
Triflow
• Control
Exercise

Locations

Country	Name	City	State
Cyprus	Eden Resort Wellness Rehabilitation Center	Larnaca

Sponsors (2)

Lead Sponsor	Collaborator
European University Cyprus	Eden Resort Wellness Rehabilitation Center

Country where clinical trial is conducted

Cyprus, 

References & Publications (11)

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. — View Citation

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. — View Citation

Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2023 Apr 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/ — View Citation

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. — View Citation

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. — View Citation

Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of hospitalisation days	Number of days participants stay in the rehabilitation center	on discharge day
Secondary	Muscle strength (Hand Grip)	Assess muscle strength for the upper extremities via hand-held dynamometer	on admission day
Secondary	Muscle strength (Hand Grip)	Assess muscle strength for the upper extremities via hand-held dynamometer	on discharge day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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