Clinical trial NCT05813873: The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome
Official title: The Use of Incentive Spirometry (Triflow) in Patients With Long Covid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Keywords: Triflow, Incentive Spirometry, Long-covid
Lead sponsor: European University Cyprus
Sponsor class: OTHER
Collaborators: name: Eden Resort Wellness Rehabilitation Center
First posted: 2023-04-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Barthel Index
timeFrame: on admission day
measure: Barthel Index
timeFrame: on discharge day
measure: Dyspnoea (Medical Research Council Dyspnoea Scale)
timeFrame: on admission day
measure: Dyspnoea (Medical Research Council Dyspnoea Scale)
timeFrame: on discharge day
measure: Peak Flow Meter
timeFrame: on admission day
measure: Peak Flow Meter
timeFrame: on discharge day
Secondary outcomes:
measure: Number of hospitalisation days
timeFrame: on discharge day
measure: Muscle strength (Hand Grip)
timeFrame: on admission day
measure: Muscle strength (Hand Grip)
timeFrame: on discharge day
measure: Muscle strength and endurance (30 seconds Sit to stand)
timeFrame: on admission day
measure: Muscle strength and endurance (30 seconds Sit to stand)
timeFrame: on discharge day
measure: Balance (Berg Balance)
timeFrame: on admission day
measure: Balance (Berg Balance)
timeFrame: on discharge day
measure: Cardiorespiratory fitness (Six minutes walking test)
timeFrame: on admission day
measure: Cardiorespiratory fitness (Six minutes walking test)
timeFrame: on discharge day
measure: Quality of life (EQ-5D-5L)
timeFrame: on admission day
measure: Quality of life (EQ-5D-5L)
timeFrame: on discharge day
measure: Fatigue (Multidimensional fatigue inventory)
timeFrame: on admission day
measure: Fatigue (Multidimensional fatigue inventory)
timeFrame: on discharge day
measure: Timed up and Go
timeFrame: on admission day
measure: Timed up and Go
timeFrame: on discharge day
Other outcomes:
Locations:
city: Larnaca
country: Cyprus
facility: Eden Resort Wellness Rehabilitation Center
Study officials:
affiliation: European University Cyprus
name: Marina Kloni
role: PRINCIPAL_INVESTIGATOR
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