Effect of Kinesio Tape Versus Diaphragmatic Breathing Exercise In Post COVID-19

Not Applicable

Completed

• Conditions: Post COVID-19 Condition
• Interventions: Other: Pursed lip breathing; Other: Cognitive Behavior Therapy; Other: Kinesio tape; Other: Diaphragmatic breathing exercise

• Registration Number: NCT05770193
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-03-10
• Study Start: 2023-03-11
• Study First Submitted QC: 2023-03-11
• Study First Posted: 2023-03-15
• Primary Completion: 2023-08-30
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

  4. Cognitive impairment. 9. Patients with red flag indicators such as chest pain, critical drop in oxygen saturation, musculoskeletal or neurologic limitations, and unconscious patients.

  5. Contraindications of using kinesio tape as Malignancy, Infection, cellulitis, Open Wound, DVT, and Previous allergic reaction to kinesio tape

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pursed lip breathing and CBT in addition to diaphragmatic breathing exercise.	Cognitive Behavior Therapy	patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to diaphragmatic breathing exercise
pursed lip breathing and CBT in addition to kinesio tape.	Cognitive Behavior Therapy	patients 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.	Pursed lip breathing	patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to diaphragmatic breathing exercise
pursed lip breathing and CBT in addition to kinesio tape.	Kinesio tape	patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to kinesio tape.
pursed lip breathing and CBT.	Pursed lip breathing	patients will receive pursed lip breathing and cognitive-behavioral therapy.
pursed lip breathing and CBT.	Cognitive Behavior Therapy	patients will receive pursed lip breathing and cognitive-behavioral therapy.
pursed lip breathing and CBT in addition to kinesio tape.	Pursed lip breathing	patients 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.	Diaphragmatic breathing exercise	patients will receive pursed lip breathing and cognitive-behavioral therapy in addition to diaphragmatic breathing exercise

Primary Outcome Measures

Name	Time	Method
Modified Medical research council	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.

Secondary Outcome Measures

Name	Time	Method
Pulse oximeter	6 weeks	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
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF).	6 weeks	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
Arabic version of The Fatigue Severity Scale	6 weeks	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.
six-minute walk test	6 weeks	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.

Trial Locations

Locations (1)

Abdallah salah abdallah gbr; 🇪🇬 Banhā, Egypt