Long COVID
Conditions
Keywords
Triflow, Incentive Spirometry, Long-covid
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.
Interventions
OTHERTriflow
Triflow
OTHERControl
Exercise
Sponsors
Eden Resort Wellness Rehabilitation Center
European University Cyprus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index | 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. |
| Dyspnoea (Medical Research Council Dyspnoea Scale) | 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 |
| Peak Flow Meter | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance (Berg Balance) | 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. |
| Cardiorespiratory fitness (Six minutes walking test) | 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. |
| Number of hospitalisation days | on discharge day | Number of days participants stay in the rehabilitation center |
| Fatigue (Multidimensional fatigue inventory) | 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) |
| Timed up and Go | on admission day | Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility |
| Quality of life (EQ-5D-5L) | 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) |
| Muscle strength (Hand Grip) | on admission day | Assess muscle strength for the upper extremities via hand-held dynamometer |
| Muscle strength and endurance (30 seconds Sit to stand) | 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 |
Countries
Cyprus
Outcome results
None listed