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NCT Number: NCT05813873

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eden Resort Wellness Rehabilitation Center

Larnaca, 7562, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triflow

Other

Triflow

Other names: Triflow and exercise regime

Control

Other

Exercise

Other names: Exercise regime

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Number of hospitalisation days

    Time frame: on discharge day

    Number of days participants stay in the rehabilitation center

  2. Muscle strength (Hand Grip)

    Time frame: on admission day

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

  3. Muscle strength (Hand Grip)

    Time frame: on discharge day

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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

European University Cyprus

Other

Collaborators

  • Eden Resort Wellness Rehabilitation Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 14, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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