Skip to main content
Clinical Trials/NCT05813873
NCT05813873
Active, not recruiting
Not Applicable

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

European University Cyprus1 site in 1 country70 target enrollmentDecember 21, 2022
ConditionsLong COVID

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Long COVID
Sponsor
European University Cyprus
Enrollment
70
Locations
1
Primary Endpoint
Peak Flow Meter
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 21, 2022
End Date
December 31, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marina Kloni

Marina Eleni Kloni, BSc, MSc, MA

European University Cyprus

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

  • Number of hospitalisation days(on discharge day)
  • Muscle strength (Hand Grip)(on discharge day)
  • Balance (Berg Balance)(on discharge day)
  • Muscle strength and endurance (30 seconds Sit to stand)(on discharge day)
  • Cardiorespiratory fitness (Six minutes walking test)(on discharge day)
  • Quality of life (EQ-5D-5L)(on discharge day)
  • Fatigue (Multidimensional fatigue inventory)(on discharge day)
  • Timed up and Go(on discharge day)

Study Sites (1)

Loading locations...

Similar Trials