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

European University Cyprus

Status: Active, not recruiting

Conditions: Long COVID

Treatments: Other: Triflow; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05813873

Triflow

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Triflow

Experimental group

Description:

Use of Triflow device and exercise regime

Treatment:

Other: Triflow

Control

Active Comparator group

Description:

Only exercise regime

Treatment:

Other: Control