The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome
- Conditions
- Long COVID
- Interventions
- Other: TriflowOther: Control
- Registration Number
- NCT05813873
- Lead Sponsor
- European University Cyprus
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triflow Triflow Use of Triflow device and exercise regime Control Control Only exercise regime
- Primary Outcome Measures
Name Time Method Peak Flow Meter 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 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) 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 Outcome Measures
Name Time Method Number of hospitalisation days on discharge day Number of days participants stay in the rehabilitation center
Muscle strength (Hand Grip) on discharge day Assess muscle strength for the upper extremities via hand-held dynamometer
Balance (Berg Balance) 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.
Muscle strength and endurance (30 seconds Sit to stand) 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
Cardiorespiratory fitness (Six minutes walking test) 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.
Quality of life (EQ-5D-5L) 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)
Fatigue (Multidimensional fatigue inventory) 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)
Timed up and Go on discharge day Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
Trial Locations
- Locations (1)
Eden Resort Wellness Rehabilitation Center
🇨🇾Larnaca, Cyprus