AzTrials
AzTrials

Long COVIDNCT05813873

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

A study testing Triflow in people with Long COVID, run by European University Cyprus at 1 site in Cyprus.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID
What is being tested?
Triflow
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCyprus
Study dates
21 Dec 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Cyprus1 site
  • Eden Resort Wellness Rehabilitation Center

    Larnaca, 7562

Other trials in Cyprus

About this study

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

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.

Conditions
Long COVID
Being tested
Triflow, Control
Keywords
Triflow, Incentive Spirometry, Long-covid
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TriflowOther

    Also called Triflow and exercise regime

    Triflow

  • ControlOther

    Also called Exercise regime

    Exercise

Study groups in NCT05813873
Study groupRoleWhat they receive
TriflowExperimentalUse of Triflow device and exercise regime
Receives: Other: Triflow
ControlActive comparatorOnly exercise regime
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: on discharge day

Secondary outcomes (15)
  1. Number of hospitalisation days

    Number of days participants stay in the rehabilitation center

    Measured: on discharge day

  2. Muscle strength (Hand Grip)

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

    Measured: on admission day

  3. Muscle strength (Hand Grip)

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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: on discharge day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start21 Dec 2022
  3. Primary completion23 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813873
Sponsor's protocol ID
Triflow
Status last verified
Mar 2025
First submitted
12 Apr 2023
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Triflow in people with Long COVID, run by European University Cyprus at 1 site in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Barthel Index (time frame: on admission day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813873, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in