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

NCT05813873 | Active Not Recruiting

• 1 other identifier: Triflow
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Keywords

Triflow, Incentive Spirometry, Long-covid

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• Number of hospitalisation days

  on discharge day

• Muscle strength (Hand Grip)

  on admission day

• Muscle strength (Hand Grip)

  on discharge day

• Muscle strength and endurance (30 seconds Sit to stand)

  on admission day

• Muscle strength and endurance (30 seconds Sit to stand)

  on discharge day

Study Arms (2)

Triflow

EXPERIMENTAL

Use of Triflow device and exercise regime

Other: Triflow

Control

ACTIVE COMPARATOR

Only exercise regime

Other: Control

Interventions

Triflow OTHER

Triflow

Also known as: Triflow and exercise regime

Triflow

Control OTHER

Exercise

Also known as: Exercise regime

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European University Cyprus: lead
• Eden Resort Wellness Rehabilitation Center: collaborator

Study Sites (1)

Eden Resort Wellness Rehabilitation Center

Larnaca, 7562, Cyprus

Location

Related 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.

  PMID: 15955148 BACKGROUND

• 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.

  PMID: 29279365 BACKGROUND

• 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.

  PMID: 34133481 BACKGROUND

• 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.

  PMID: 32388326 BACKGROUND

• 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.

  PMID: 33558097 BACKGROUND

• 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.

  PMID: 33364571 BACKGROUND

• 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.

  PMID: 33800094 BACKGROUND

• 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.

  PMID: 33784696 BACKGROUND

• Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2023 Apr 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/

  PMID: 34283480 BACKGROUND

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

  PMID: 22008401 BACKGROUND

• 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.

  PMID: 34754645 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Kloni

  European University Cyprus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marina Eleni Kloni, BSc, MSc, MA

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 14, 2023
• Study Start: December 21, 2022
• Primary Completion: December 23, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)