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

August 10, 2025 updated by: Marina Kloni, European University Cyprus

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Larnaca, Cyprus, 7562
        • Eden Resort Wellness Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triflow
Use of Triflow device and exercise regime
Other: Triflow
Triflow
Other Names:
  • Triflow and exercise regime
Active Comparator: Control
Only exercise regime
Other: Control
Exercise
Other Names:
  • Exercise regime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: 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.
on admission day
Barthel Index
Time Frame: 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.
on discharge day
Dyspnoea (Medical Research Council Dyspnoea Scale)
Time Frame: 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
on admission day
Dyspnoea (Medical Research Council Dyspnoea Scale)
Time Frame: 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
on discharge day
Peak Flow Meter
Time Frame: 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
on admission day
Peak Flow Meter
Time Frame: 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
on discharge day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hospitalisation days
Time Frame: on discharge day
Number of days participants stay in the rehabilitation center
on discharge day
Muscle strength (Hand Grip)
Time Frame: on admission day
Assess muscle strength for the upper extremities via hand-held dynamometer
on admission day
Muscle strength (Hand Grip)
Time Frame: on discharge day
Assess muscle strength for the upper extremities via hand-held dynamometer
on discharge day
Muscle strength and endurance (30 seconds Sit to stand)
Time Frame: 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
on admission day
Muscle strength and endurance (30 seconds Sit to stand)
Time Frame: 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
on discharge day
Balance (Berg Balance)
Time Frame: 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.
on admission day
Balance (Berg Balance)
Time Frame: 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.
on discharge day
Cardiorespiratory fitness (Six minutes walking test)
Time Frame: 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.
on admission day
Cardiorespiratory fitness (Six minutes walking test)
Time Frame: 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.
on discharge day
Quality of life (EQ-5D-5L)
Time Frame: 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)
on admission day
Quality of life (EQ-5D-5L)
Time Frame: 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)
on discharge day
Fatigue (Multidimensional fatigue inventory)
Time Frame: 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)
on admission day
Fatigue (Multidimensional fatigue inventory)
Time Frame: 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)
on discharge day
Timed up and Go
Time Frame: on admission day
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
on admission day
Timed up and Go
Time Frame: on discharge day
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
on discharge day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University Cyprus

Collaborators

Eden Resort Wellness Rehabilitation Center

Investigators

  • Principal Investigator: Marina Kloni, European University Cyprus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Estimated)

December 23, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Triflow

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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