Post COVID-19 ConditionNCT05770193
Effect of Kinesio Tape Versus Diaphragmatic Breathing Exercise In Post COVID-19
A study testing Pursed lip breathing, Cognitive Behavior Therapy and Diaphragmatic breathing exercise in people with Post COVID-19 Condition, run by Cairo University at 1 site in Egypt.
Trial summary
According to WHO, current evidence suggests some people experience a variety of long-term effects after they recover from their initial illness. These effects are collectively known as post COVID-19 condition or "long COVID. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- Pursed lip breathing, Cognitive Behavior Therapy and Diaphragmatic breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People who have a history of probable or confirmed SARS-CoV-2 infection; usually within three months from the onset of COVID-19, with symptoms and effects that last for at least two months.
- Aged 18-45 years old.
- Non-hospitalized.
- Both sexes will be included.
- Body mass index (BMI) range from (18.5 to 24.9 kg/m2).
- Patients with low to moderate physical activity, according to the International Physical Activity Questionnaire (IPAQ) Arabic version.
Show all 9Show fewer
- Patients with grade 2 or higher on Modified Medical research council (Dyspnea Scale).
- Able to read and write.
- Willing and able to complete study procedures. -
Who cannot join
- 1. Patients on medications that would influence exercise performance such as beta-blockers or antiretroviral therapy.
- 2. Enrolled in another interventional clinical research trial in the previous 30 days.
- 3. Pregnancy. 4. Had significant hepatic or renal dysfunction. 5. New onset of arrhythmia and myocardial ischemia. 6. Hospitalized. 7. Cardiac disease, chronic respiratory disease, active infection, severe endocrine or metabolic diseases.
- 8. Cognitive impairment. 9. Patients with red flag indicators such as chest pain, critical drop in oxygen saturation, musculoskeletal or neurologic limitations, and unconscious patients.
- 10. Contraindications of using kinesio tape as Malignancy, Infection, cellulitis, Open Wound, DVT, and Previous allergic reaction to kinesio tape
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Kinesio Tape Versus Diaphragmatic Breathing Exercise In Post COVID-19 Patients(A Comparative Study)
According to WHO, current evidence suggests some people experience a variety of long-term effects after they recover from their initial illness. These effects are collectively known as post COVID-19 condition or "long COVID. While most people who develop COVID-19 fully recover, some people develop effects like fatigue, breathlessness, functional activities and cognitive dysfunction. At present, there is no specific medication therapy for people with post COVID-19 condition.
Read the detailed description
Lungs are the main organs affected by the virus so many respiratory complications occur, like increasing breathing effort marked by the usage of auxiliary respiratory muscle and paradoxical breathing pattern. However, when a patient with the corona virus become negative, the symptoms during Covid-19 infection do not immediately disappear, these symptoms can even continue for months. A study on Long Covid stated that, about 87.4% of people reported feeling at least one persistent symptom and the most common was chronic fatigue and shortness of breath. Physiotherapy rehabilitation, such as breathing exercises and chest physiotherapy, can be effective adjuvant therapies in COVID-19 patients. Different therapies are suggested to treat Covid-19 complications as Pursed lip breathing exercise which is effective in improving respiratory rate and reducing dyspnea in Covid-19 patients.
Cognitive Behavior Therapy (CBT) has a great impact in promoting the physical and psychological health of patients during COVID-19.
A series of recent studies has indicated that, a telerehabilitation program consisting of 1-week respiratory exercises was found to be effective, safe, and feasible in Covid-19 patients with mild to moderate symptomatology. A recent study by Cascella et al. concluded that, breathing exercises and chest therapy can be used to help post COVID-19 patients regain their normal breathing capacity.
kinesio tape helps with neuromusculoskeletal rehabilitation by activating cutaneous mechanoreceptors, which interact with deeper tissues via continuous sensory and mechanical stimuli in the skin, forming a neural arc and proper motor response. In patients with COPD, Kinesio tape combined with deep breathing exercises significantly improved pulmonary function, perceived severity of dyspnea, and fatigue, and had a positive effect on functional capacity.
Desai et al. concluded in their study that, kinesio tape applied to the diaphragm has a good prognosis for diaphragm muscle weakness. It improved maximum inspiratory pressure and diaphragmatic excursion range.
60 Patients will be assignment randomly into three groups: Group A: 20 patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to kinesio tape.
Group B: 20 patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to diaphragmatic breathing exercise.
Group C: 20 patients will receive pursed lip breathing and cognitive-behavioral therapy.
- Conditions
- Post COVID-19 Condition
- Being tested
- Pursed lip breathing, Cognitive Behavior Therapy, Diaphragmatic breathing exercise, Kinesio tape
- Keywords
- Kinesio tape, Diaphragmatic breathing exercise, Post COVID-19, six-minute walk test, Oxygen Saturation, Fatigue Severity Scale, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursed lip breathingOther
The position for every patient will be long sitting, and then he will be instructed to breathe in through the nose for 2 seconds. Purse the lips as if about to blow out the candles on a cake. Breathe out very slowly through pursed lips for 4 to 6 seconds, and then repeat for 5 to 10 minutes. The intervention will be done two days a week, through six weeks for all participants by a physiotherapist.
Cognitive Behavior TherapyOther
Also called (CBT)
A structured, 6-session psycho-therapeutic intervention, occurring once weekly, will be performed According to the CBT session structure provided by Cully and Teten, with some modifications, Each session will be approximately 1 hour.
Diaphragmatic breathing exerciseOther
The patient will lie in supine position, and then he will be asked to rest for 5 min and lay on their back on a flat surface with pillows under their head and knees for support. One hand will be placed on the abdomen and the other on the upper part of the chest wall. When inhaling, the hand on the abdomen will move upward, while the other hand will remain as still as possible. When exhaling, the hand on the abdomen will move downwards, while the other hand will remain as still as possible again. Breathing will be performed quickly, deeply and without causing tiredness. The breaths should be inhaled through the nose and exhaled through the mouth.
The diaphragmatic breathing exercise will consist of three sets of 10 repetitions, with 30 seconds of rest between each set
Kinesio tapeOther
The position for every patient will be sitting during application of the tape. The diaphragm muscle will be covered with kinesio tape both anteriorly and posteriorly along the subcostal region. Anteriorly, the base point of an "I" shaped kinesio tape will be applied on xiphoid process with 50_75% tension on the linea Alba and the tails of the tape were applied toward subcostal curvature. Posteriorly, a second "I" shaped Kinesio Tape will be applied from the back The base point of the tape will be applied on the projection of 12th Thoracic vertebra with 50 _75% tension and the tails will be applied toward the ribs.
| Study group | Role | What they receive |
|---|---|---|
| pursed lip breathing and CBT in addition to kinesio tape. | Experimental | patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to kinesio tape. Receives: Other: Pursed lip breathing; Other: Cognitive Behavior Therapy; Other: Kinesio tape |
| pursed lip breathing and CBT in addition to diaphragmatic breathing exercise. | Experimental | patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to diaphragmatic breathing exercise Receives: Other: Pursed lip breathing; Other: Cognitive Behavior Therapy; Other: Diaphragmatic breathing exercise |
| pursed lip breathing and CBT. | Active comparator | patients will receive pursed lip breathing and cognitive-behavioral therapy. Receives: Other: Pursed lip breathing; Other: Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical research council
It will used to assess Dyspnea, This test is very easy to perform; it is valid and correlates with clinical parameters and parameters of respiratory function.
Measured: 6 weeks
Secondary outcomes (4)
Pulse oximeter
It will be used to measure oxygen saturation. It is a valid tool to measure oxygen saturation. Powers et al, concluded that Pulse oximeter is useful tool in estimating percent arterial oxygen saturation of hemoglobin in healthy subjects.
It will be attached to the thump and the reading will be recorded
Measured: 6 weeks
Arabic version of The Fatigue Severity Scale
It will be used to measure fatigue level. The FSS showed satisfactory reliability and validity and thus can be regarded as a feasible measure of self-reported fatigue.
In addition to measuring the presence and degree of fatigue in a sample of Arabic patients, the Arabic version of the FSS also shown indications of internal consistency, relative test-retest reliability, and construct validity, supporting its application in clinical practice and research.
Measured: 6 weeks
six-minute walk test
It will be used to measure physical or functional performance. The 6-min walk is a reliable and valid measure of physical endurance in older adults and it moderately reflects overall physical functional performance.
A newer application of the six-minute walk test is noted for patients who have had COVID-19 pneumonia with prolonged respiratory symptoms.
Measured: 6 weeks
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF).
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life.
The Arabic translation of the WHOQOL-BREF has impressive reliability and validity indices. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domain scores are scaled in a positive direction higher scores denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start11 Mar 2023
- Primary completion30 Aug 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Salah Abdallah Gabr, Cairo University
- Investigators
- fatma S Amin, Principal investigator, Professor of Basic Science / Faculty of Physical therapy/ Cairo universityDoaa A Elimy, Principal investigator, Lecturer of Basic Science /Faculty of Physical therapy/ Cairo universityAhmed A mohamed, Principal investigator, Professor of chest disease Faculty of medicine banha university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770193
- Sponsor's protocol ID
- P.T.REC/012/004370
- Status last verified
- Dec 2023
- First submitted
- 10 Mar 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Kinesio Tape Versus Diaphragmatic Breathing Exercise In Post COVID-19 Patients(A Comparative Study)
- ClinicalTrials.gov ID
- NCT05770193
- Acronym / sponsor ID
- P.T.REC/012/004370
- Conditions
- Post COVID-19 Condition
- Keywords
- Kinesio tape, Diaphragmatic breathing exercise, Post COVID-19, six-minute walk test, Oxygen Saturation, Fatigue Severity Scale, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Mar 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to WHO, current evidence suggests some people experience a variety of long-term effects after they recover from their initial illness. These effects are collectively known as post COVID-19 condition or "long COVID. While most people who develop COVID-19 fully recover, some people develop effects like fatigue, breathlessness, functional activities and cognitive dysfunction. At present, there is no specific medication therapy for people with post COVID-19 condition.
Detailed description
Lungs are the main organs affected by the virus so many respiratory complications occur, like increasing breathing effort marked by the usage of auxiliary respiratory muscle and paradoxical breathing pattern. However, when a patient with the corona virus become negative, the symptoms during Covid-19 infection do not immediately disappear, these symptoms can even continue for months. A study on Long Covid stated that, about 87.4% of people reported feeling at least one persistent symptom and the most common was chronic fatigue and shortness of breath. Physiotherapy rehabilitation, such as breathing exercises and chest physiotherapy, can be effective adjuvant therapies in COVID-19 patients. Different therapies are suggested to treat Covid-19 complications as Pursed lip breathing exercise which is effective in improving respiratory rate and reducing dyspnea in Covid-19 patients.
Cognitive Behavior Therapy (CBT) has a great impact in promoting the physical and psychological health of patients during COVID-19.
A series of recent studies has indicated that, a telerehabilitation program consisting of 1-week respiratory exercises was found to be effective, safe, and feasible in Covid-19 patients with mild to moderate symptomatology. A recent study by Cascella et al. concluded that, breathing exercises and chest therapy can be used to help post COVID-19 patients regain their normal breathing capacity.
kinesio tape helps with neuromusculoskeletal rehabilitation by activating cutaneous mechanoreceptors, which interact with deeper tissues via continuous sensory and mechanical stimuli in the skin, forming a neural arc and proper motor response. In patients with COPD, Kinesio tape combined with deep breathing exercises significantly improved pulmonary function, perceived severity of dyspnea, and fatigue, and had a positive effect on functional capacity.
Desai et al. concluded in their study that, kinesio tape applied to the diaphragm has a good prognosis for diaphragm muscle weakness. It improved maximum inspiratory pressure and diaphragmatic excursion range.
60 Patients will be assignment randomly into three groups: Group A: 20 patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to kinesio tape.
Group B: 20 patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to diaphragmatic breathing exercise.
Group C: 20 patients will receive pursed lip breathing and cognitive-behavioral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pursed lip breathing and CBT in addition to kinesio tape. | Experimental | Other: Pursed lip breathing, Other: Cognitive Behavior Therapy, Other: Kinesio tapepatients will receive pursed lip breathing and cognitive-behavioral therapy in addition to kinesio tape. |
| pursed lip breathing and CBT in addition to diaphragmatic breathing exercise. | Experimental | Other: Pursed lip breathing, Other: Cognitive Behavior Therapy, Other: Diaphragmatic breathing exercisepatients will receive pursed lip breathing and cognitive-behavioral therapy in addition to diaphragmatic breathing exercise |
| pursed lip breathing and CBT. | Active comparator | Other: Pursed lip breathing, Other: Cognitive Behavior Therapypatients will receive pursed lip breathing and cognitive-behavioral therapy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- People who have a history of probable or confirmed SARS-CoV-2 infection; usually within three months from the onset of COVID-19, with symptoms and effects that last for at least two months.
- Aged 18-45 years old.
- Non-hospitalized.
- Both sexes will be included.
- Body mass index (BMI) range from (18.5 to 24.9 kg/m2).
Key exclusion criteria (5 listed)
- 1. Patients on medications that would influence exercise performance such as beta-blockers or antiretroviral therapy.
- 2. Enrolled in another interventional clinical research trial in the previous 30 days.
- 3. Pregnancy. 4. Had significant hepatic or renal dysfunction. 5. New onset of arrhythmia and myocardial ischemia. 6. Hospitalized. 7. Cardiac disease, chronic respiratory disease, active infection, severe endocrine or metabolic diseases.
- 8. Cognitive impairment. 9. Patients with red flag indicators such as chest pain, critical drop in oxygen saturation, musculoskeletal or neurologic limitations, and unconscious patients.
- 10. Contraindications of using kinesio tape as Malignancy, Infection, cellulitis, Open Wound, DVT, and Previous allergic reaction to kinesio tape
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pursed lip breathingThe position for every patient will be long sitting, and then he will be instructed to breathe in through the nose for 2 seconds. Purse the lips as if about to blow out the candles on a cake. Breathe out very slowly through pursed lips for 4 to 6 seconds, and then repeat for 5 to 10 minutes. The intervention will be done two days a week, through six weeks for all participants by a physiotherapist. | Other | pursed lip breathing and CBT in addition to diaphragmatic breathing exercise., pursed lip breathing and CBT in addition to kinesio tape., pursed lip breathing and CBT. |
| Cognitive Behavior TherapyAlso: (CBT)A structured, 6-session psycho-therapeutic intervention, occurring once weekly, will be performed According to the CBT session structure provided by Cully and Teten, with some modifications, Each session will be approximately 1 hour. | Other | pursed lip breathing and CBT in addition to diaphragmatic breathing exercise., pursed lip breathing and CBT in addition to kinesio tape., pursed lip breathing and CBT. |
| Diaphragmatic breathing exerciseThe patient will lie in supine position, and then he will be asked to rest for 5 min and lay on their back on a flat surface with pillows under their head and knees for support. One hand will be placed on the abdomen and the other on the upper part of the chest wall. When inhaling, the hand on the abdomen will move upward, while the other hand will remain as still as possible. When exhaling, the hand on the abdomen will move downwards, while the other hand will remain as still as possible again. Breathing will be performed quickly, deeply and without causing tiredness. The breaths should be inhaled through the nose and exhaled through the mouth. The diaphragmatic breathing exercise will consist of three sets of 10 repetitions, with 30 seconds of rest between each set | Other | pursed lip breathing and CBT in addition to diaphragmatic breathing exercise. |
| Kinesio tapeThe position for every patient will be sitting during application of the tape. The diaphragm muscle will be covered with kinesio tape both anteriorly and posteriorly along the subcostal region. Anteriorly, the base point of an "I" shaped kinesio tape will be applied on xiphoid process with 50_75% tension on the linea Alba and the tails of the tape were applied toward subcostal curvature. Posteriorly, a second "I" shaped Kinesio Tape will be applied from the back The base point of the tape will be applied on the projection of 12th Thoracic vertebra with 50 _75% tension and the tails will be applied toward the ribs. | Other | pursed lip breathing and CBT in addition to kinesio tape. |
Primary outcome
Modified Medical research council
Time frame: 6 weeks
It will used to assess Dyspnea, This test is very easy to perform; it is valid and correlates with clinical parameters and parameters of respiratory function.
4 secondary outcomes
Pulse oximeter
Time frame: 6 weeks
Arabic version of The Fatigue Severity Scale
Time frame: 6 weeks
six-minute walk test
Time frame: 6 weeks
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF).
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Yes. Study results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fatma S Amin principal investigator
Professor of Basic Science / Faculty of Physical therapy/ Cairo university
Doaa A Elimy principal investigator
Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university
Ahmed A mohamed principal investigator
Professor of chest disease Faculty of medicine banha university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursed lip breathing, Cognitive Behavior Therapy and Diaphragmatic breathing exercise in people with Post COVID-19 Condition, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Medical research council (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.