Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients

NCT04613050 | Completed

• 1 other identifier: MAHA2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted on eighty patients of both sexes with age ranging from 35 to 45years. The will be recovered from COVID-19 infection with chest symptoms. They will be selected from Nasr city police authority hospital. They will be randomly assigned into 3 equal groups.

Conditions

Covid 19 Infection

Outcome Measures

Primary Outcomes (6)

• Complete blood picture

  A venous blood sample will be taken to be analyzed in the laboratory

  change from baseline at 6 weeks

• Arterial blood gases

  arterial blood sample will be assessed

  change from baseline at 6 weeks

• 6-minute walk Distance

  patient will be instructed to walk as fast as long as possible, in a 30 meters obstacle- free corridor, limited by turnaround cones. Standardized verbal encouragement will be given every minute. After 6 min, patient will be instructed to stop, and the total distance will be measured, rounding to the nearest meter.

  change from baseline at 6 weeks

• Breath-hold test

  A rough index of cardiopulmonary reserve measured by the length of time that a person can voluntarily stop breathing; normal duration is 30 seconds or longer; diminished cardiac or pulmonary reserve is indicated by a duration of 20 seconds or less.

  change from baseline at 6 weeks

• Oxygen saturation

  Percentage of haemoglobin saturated with oxygen measured by pulse oximeter

  change from baseline at 6 weeks

• Borg Dyspnea Scale score

  It is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during six minute walk test

  change from baseline at 6 weeks

Secondary Outcomes (1)

• Maximum oxygen consumption

  change from baseline at 6 weeks

Study Arms (3)

Group A (Respiratory Training Group)

ACTIVE COMPARATOR

It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive respiratory training for 6 weeks.

Other: Respiratory Training

Group B : (Aerobic Training Group)

ACTIVE COMPARATOR

It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive aerobic training for 6 weeks

Other: Aerobic training

Group C : (control group)

NO INTERVENTION

It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group.

Interventions

Respiratory Training OTHER

Respiratory training in form of : Diaphragmatic breathing,Segmental breathing, Incentive spirometer:

Group A (Respiratory Training Group)

Aerobic training OTHER

aerobic exercises are customized according to the patient's underlying disease and residual dysfunction. These exercises will include walking on treadmill. After an initial, 5-minute warm-up phase performed on the treadmill at a low load, each endurance training session lasted 30 minutes and ended with 5-minute recovery and relaxation phase. A total of 3-5 sessions are carried out per week. Patients who are prone to fatigue should perform intermittent exercises

Group B : (Aerobic Training Group)

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients recovered from COVID -19 infection.
• Patients with body mass index 25 - 35 kg/m2
• Patients previously diagnosed with chest symptoms of COVID- 19 infection.
• Patients' body temperature less than 37.5
• Blood oxygen saturation ≥95%

You may not qualify if:

• Smokers
• Patients with Myocardial infarction
• Patients with diabetes.
• Patients with autoimmune disease.
• Patients with positive COVID -19 infection.
• Patients with previous chest diseases
• a heart rate of \>100 bpm
• a blood pressure of \<90/60 mmHg or \>140/90 mmHg
• a blood oxygen saturation of ≤95%
• other diseases that are not suitable for exercise (osteoarthritis knee - stroke patients, etc)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Police hospital-Nasr city

Cairo, 002, Egypt

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 3, 2020
• Study Start: July 2, 2020
• Primary Completion: October 24, 2022
• Study Completion: October 30, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

EG (1)