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

Primary Purpose

Long COVID

Status
Recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Triflow
Control
Sponsored by
European University Cyprus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID focused on measuring Triflow, Incentive Spirometry, Long-covid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eden Resort Wellness Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Triflow

Control

Arm Description

Use of Triflow device and exercise regime

Only exercise regime

Outcomes

Primary Outcome Measures

Barthel Index
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.
Barthel Index
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)
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
Dyspnoea (Medical Research Council Dyspnoea Scale)
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
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
Peak Flow Meter
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 Outcome Measures

Number of hospitalisation days
Number of days participants stay in the rehabilitation center
Muscle strength (Hand Grip)
Assess muscle strength for the upper extremities via hand-held dynamometer
Muscle strength (Hand Grip)
Assess muscle strength for the upper extremities via hand-held dynamometer
Muscle strength and endurance (30 seconds Sit to stand)
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
Muscle strength and endurance (30 seconds Sit to stand)
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
Balance (Berg Balance)
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.
Balance (Berg Balance)
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)
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.
Cardiorespiratory fitness (Six minutes walking test)
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)
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)
Quality of life (EQ-5D-5L)
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)
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)
Fatigue (Multidimensional fatigue inventory)
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
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
Timed up and Go
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility

Full Information

First Posted
April 12, 2023
Last Updated
September 6, 2023
Sponsor
European University Cyprus
Collaborators
Eden Resort Wellness Rehabilitation Center
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1. Study Identification

Unique Protocol Identification Number
NCT05813873
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
December 23, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University Cyprus
Collaborators
Eden Resort Wellness Rehabilitation Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID
Keywords
Triflow, Incentive Spirometry, Long-covid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triflow
Arm Type
Experimental
Arm Description
Use of Triflow device and exercise regime
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Only exercise regime
Intervention Type
Other
Intervention Name(s)
Triflow
Other Intervention Name(s)
Triflow and exercise regime
Intervention Description
Triflow
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Exercise regime
Intervention Description
Exercise
Primary Outcome Measure Information:
Title
Barthel Index
Description
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.
Time Frame
on admission day
Title
Barthel Index
Description
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.
Time Frame
on discharge day
Title
Dyspnoea (Medical Research Council Dyspnoea Scale)
Description
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
Time Frame
on admission day
Title
Dyspnoea (Medical Research Council Dyspnoea Scale)
Description
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
Time Frame
on discharge day
Title
Peak Flow Meter
Description
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
Time Frame
on admission day
Title
Peak Flow Meter
Description
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
Time Frame
on discharge day
Secondary Outcome Measure Information:
Title
Number of hospitalisation days
Description
Number of days participants stay in the rehabilitation center
Time Frame
on discharge day
Title
Muscle strength (Hand Grip)
Description
Assess muscle strength for the upper extremities via hand-held dynamometer
Time Frame
on admission day
Title
Muscle strength (Hand Grip)
Description
Assess muscle strength for the upper extremities via hand-held dynamometer
Time Frame
on discharge day
Title
Muscle strength and endurance (30 seconds Sit to stand)
Description
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
Time Frame
on admission day
Title
Muscle strength and endurance (30 seconds Sit to stand)
Description
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
Time Frame
on discharge day
Title
Balance (Berg Balance)
Description
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.
Time Frame
on admission day
Title
Balance (Berg Balance)
Description
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.
Time Frame
on discharge day
Title
Cardiorespiratory fitness (Six minutes walking test)
Description
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.
Time Frame
on admission day
Title
Cardiorespiratory fitness (Six minutes walking test)
Description
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.
Time Frame
on discharge day
Title
Quality of life (EQ-5D-5L)
Description
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)
Time Frame
on admission day
Title
Quality of life (EQ-5D-5L)
Description
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)
Time Frame
on discharge day
Title
Fatigue (Multidimensional fatigue inventory)
Description
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)
Time Frame
on admission day
Title
Fatigue (Multidimensional fatigue inventory)
Description
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)
Time Frame
on discharge day
Title
Timed up and Go
Description
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
Time Frame
on admission day
Title
Timed up and Go
Description
Assesses mobility and fall risk. Participants have to walk 3m, the shorter the time the better their mobility
Time Frame
on discharge day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina E Kloni
Phone
0035799007245
Email
marina.eleni@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Kloni
Organizational Affiliation
European University Cyprus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eden Resort Wellness Rehabilitation Center
City
Larnaca
ZIP/Postal Code
7562
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thea Panteli

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15955148
Citation
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Results Reference
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Results Reference
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PubMed Identifier
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Spielmanns M, Pekacka-Egli AM, Schoendorf S, Windisch W, Hermann M. Effects of a Comprehensive Pulmonary Rehabilitation in Severe Post-COVID-19 Patients. Int J Environ Res Public Health. 2021 Mar 7;18(5):2695. doi: 10.3390/ijerph18052695.
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Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2023 Apr 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/
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The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome

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