Clinical trial NCT05770193: Effect of Kinesio Tape Versus Diaphragmatic Breathing Exercise In Post COVID-19
Official title: Effect Of Kinesio Tape Versus Diaphragmatic Breathing Exercise In Post COVID-19 Patients(A Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Aged 18-45 years old.
3. Non-hospitalized.
4. Both sexes will be included.
5. Body mass index (BMI) range from (18.5 to 24.9 kg/m2).
6. Patients with low to moderate physical activity, according to the International Physical Activity Questionnaire (IPAQ) Arabic version.
7. Patients with grade 2 or higher on Modified Medical research council (Dyspnea Scale).
8. Able to read and write.
9. Willing and able to complete study procedures. -

Exclusion Criteria:

* 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

Primary outcomes:
measure: Modified Medical research council
timeFrame: 6 weeks
Secondary outcomes:
measure: Pulse oximeter
timeFrame: 6 weeks
measure: Arabic version of The Fatigue Severity Scale
timeFrame: 6 weeks
measure: six-minute walk test
timeFrame: 6 weeks
measure: The World Health Organization Quality-of-Life Scale (WHOQOL-BREF).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Abdallah salah abdallah gbr
Study officials:
affiliation: Professor of Basic Science / Faculty of Physical therapy/ Cairo university
name: fatma S Amin
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university
name: Doaa A Elimy
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of chest disease Faculty of medicine banha university
name: Ahmed A mohamed
role: PRINCIPAL_INVESTIGATOR
References: