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Active, not recruitingNCT05813873Updated Aug 14, 2025

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

An interventional study of Triflow and Control in Long COVID, sponsored by European University Cyprus. Active, not recruiting at 1 site in Cyprus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by European University Cyprus · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Dec 2022, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Long COVID

Keywords

  • Triflow, Incentive Spirometry, Long-covid
03

In context

Post-Acute COVID-19 Syndrome

604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.

This study's planned enrollment of 70 is above the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

European University Cyprus is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Triflow

    Use of Triflow device and exercise regime

    Other: Triflow

  • Active comparator
    Control

    Only exercise regime

    Other: Control

Interventions

  • OtherTriflow

    Triflow

    Also known as: Triflow and exercise regime

  • OtherControl

    Exercise

    Also known as: Exercise regime

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: on admission day

  2. 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.

    Time frame: on discharge day

  3. 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

    Time frame: on admission day

  4. 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

    Time frame: on discharge day

  5. 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

    Time frame: on admission day

  6. 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

    Time frame: on discharge day

Secondary outcomes

  1. Number of hospitalisation days

    Number of days participants stay in the rehabilitation center

    Time frame: on discharge day

  2. Muscle strength (Hand Grip)

    Assess muscle strength for the upper extremities via hand-held dynamometer

    Time frame: on admission day

  3. Muscle strength (Hand Grip)

    Assess muscle strength for the upper extremities via hand-held dynamometer

    Time frame: on discharge day

  4. 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

    Time frame: on admission day

  5. 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

    Time frame: on discharge day

  6. 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.

    Time frame: on admission day

  7. 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.

    Time frame: on discharge day

  8. 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.

    Time frame: on admission day

  9. 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.

    Time frame: on discharge day

  10. 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)

    Time frame: on admission day

  11. 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)

    Time frame: on discharge day

  12. 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)

    Time frame: on admission day

  13. 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)

    Time frame: on discharge day

  14. Timed up and Go

    Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility

    Time frame: on admission day

  15. Timed up and Go

    Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility

    Time frame: on discharge day

07

Study locations

1 site
  • Eden Resort Wellness Rehabilitation Center
    Larnaca, 7562, Cyprus
08

References and documents

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. PubMed 15955148 ↗
  • 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. PubMed 29279365 ↗
  • 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. PubMed 34133481 ↗
  • 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. PubMed 32388326 ↗
  • 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. PubMed 33558097 ↗
  • 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. PubMed 33364571 ↗
  • 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. PubMed 33800094 ↗
  • 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. PubMed 33784696 ↗
  • Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2023 Apr 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/ PubMed 34283480 ↗
  • Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471. PubMed 22008401 ↗
  • 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. PubMed 34754645 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05813873
Lead sponsor
European University Cyprus
Collaborators
Eden Resort Wellness Rehabilitation Center
Responsible party
Marina Kloni (Marina Eleni Kloni, BSc, MSc, MA, European University Cyprus) — Principal investigator
First posted
Apr 14, 2023
Start date
Dec 21, 2022
Primary completion
Dec 23, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 14, 2025

Study contacts

Marina Kloni
principal investigator · European University Cyprus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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