NCT05770193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 11, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

March 10, 2023

Last Update Submit

December 3, 2023

Conditions

Keywords

Kinesio tapeDiaphragmatic breathing exercisePost COVID-19six-minute walk testOxygen SaturationFatigue Severity ScaleQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (4)

  • Pulse oximeter

    6 weeks

  • Arabic version of The Fatigue Severity Scale

    6 weeks

  • six-minute walk test

    6 weeks

  • The World Health Organization Quality-of-Life Scale (WHOQOL-BREF).

    6 weeks

Study Arms (3)

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.

Other: Pursed lip breathingOther: Cognitive Behavior TherapyOther: 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

Other: Pursed lip breathingOther: Cognitive Behavior TherapyOther: Diaphragmatic breathing exercise

pursed lip breathing and CBT.

ACTIVE COMPARATOR

patients will receive pursed lip breathing and cognitive-behavioral therapy.

Other: Pursed lip breathingOther: Cognitive Behavior Therapy

Interventions

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.

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.

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.

Also known as: (CBT)
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.

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

pursed lip breathing and CBT in addition to diaphragmatic breathing exercise.

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.

pursed lip breathing and CBT in addition to kinesio tape.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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. -

You may not qualify if:

  • \. Patients on medications that would influence exercise performance such as beta-blockers or antiretroviral therapy.
  • \. Enrolled in another interventional clinical research trial in the previous 30 days.
  • \. 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.
  • \. Cognitive impairment. 9. Patients with red flag indicators such as chest pain, critical drop in oxygen saturation, musculoskeletal or neurologic limitations, and unconscious patients.
  • \. Contraindications of using kinesio tape as Malignancy, Infection, cellulitis, Open Wound, DVT, and Previous allergic reaction to kinesio tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdallah salah abdallah gbr

Banhā, Egypt

Location

MeSH Terms

Interventions

Cognitive Behavioral TherapyAthletic Tape

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesBandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • fatma S Amin

    Professor of Basic Science / Faculty of Physical therapy/ Cairo university

    PRINCIPAL INVESTIGATOR
  • Doaa A Elimy

    Lecturer of Basic Science /Faculty of Physical therapy/ Cairo university

    PRINCIPAL INVESTIGATOR
  • Ahmed A mohamed

    Professor of chest disease Faculty of medicine banha university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. in Physical Therapy Cairo University

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 15, 2023

Study Start

March 11, 2023

Primary Completion

August 30, 2023

Study Completion

November 30, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
Study protocol

Locations