Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401627549473 Date of Approval: 23/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of different exercises on ventilatory functions in chronic post-COVID pulmonary fibrosis
Official scientific title Effect of different exercises on ventilatory functions in chronic post-COVID pulmonary fibrosis
Brief summary describing the background and objectives of the trial Pulmonary fibrosis has the most significant long-term impact on patients’ respiratory health following post- COVID pulmonary fibrosis with negative consequences on ventilatory functions. Exercise is considered an important part of care for individuals with pulmonary fibrosis. Several studies solely listed the benefits of different exercise types including aerobic, resistance and combined exercises on different outcomes in patients with chronic pulmonary fibrosis without identifying the most effective form of training. This study is considered as a unique addition to the area of exercise training in chronic post-COVID pulmonary fibrosis in order to reconcile differences in the findings of previous studies that looked at the influence of one kind of exercise on limited outcomes in chronic post-COVID pulmonary fibrosis patients. This research gives healthcare practitioners who treat chronic post-COVID pulmonary fibrosis patients more information about the effectiveness of different types of exercises. One factor for the inadequate referral of such patients to physiotherapy may be a lack of understanding about the benefits of exercise in such persons. Furthermore, various forms of exercise appear to be a low-cost intervention that requires little equipment. So, the aim of this trial is evaluate the effect of aerobic, resistance and combined exercises on ventilatory functions in chronic post-COVID pulmonary fibrosis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 30/01/2024
Actual trial start date 03/02/2024
Anticipated date of last follow up 09/05/2024
Actual Last follow-up date 12/05/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Resistance training Low- to moderate-intensity resistance exercise training at 55-65% of one repetition maximum (1RM) and diaphragmatic breathing exercises 10 weeks lateral pull down, bench press, biceps curls, abdominal crunch, leg press, hip abduction and calf raises exercises.5-10 minutes warming-up in the form of stretching and flexibility exercises. This is followed by the active phase (20-50 minutes) during which a 5-10 seconds passive rest will be allowed in-between repetitions (Muscle relaxation time will be> muscle contraction time) and 1-2 minute passive recovery will be permitted in-between sets. There will be also a cooling down phase for 5 minutes in the form of stretching exercises. Diaphragmatic breathing in a rate of six breaths per minute and take rest between sets for one minute through a session of 30 minutes 15
Experimental Group Aerobic training Low- to moderate- intensity aerobic training at (55 to 65 %) of maxHR and diaphragmatic breathing. 10 weeks 30 to 45 minutes of running. Also, there will be a 5-10 min warming-up and a 3-min cooling down. Diaphragmatic breathing in a rate of six breaths per minute and take rest between sets for one minute through a session of 30 minutes. 15
Experimental Group Combined aerobic and resistance exercises Low to moderate intensity aerobic training at 55 to 65 % of HRpeak in combination with low to moderate intensity resistance exercise training at 55-65% of 1RM and diaphragmatic breathing. 10 weeks The active phase of exercise will be from 20-25 aerobic exercise followed by 5 minutes of rest then 20-35 minutes of resistance exercises. Also, there will be a 5-10 min warming-up and a 5-min cooling down. Diaphragmatic breathing in a rate of six breaths per minute and take rest between sets for one minute through a session of 30 minutes 15
Control Group Diaphragmatic breathing 3 times weekly, every session 30 minutes 10 weeks While lying in crook laying position, the patient will be instructed to slowly inhale through nose, feeling the air flow in, and lift the abdomen upward. Then, with a sigh, slowly let the air out through your mouth breathe in a rate of six breaths per minute and take rest between sets for one minute through a session of 30 minutes. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Chronic Post-COVID pulmonary fibrosis. 2. Covid 19 infection more than 6 months ago. 3. Persistence dyspnea (≥2 and <7 on modified dyspnea Borg scale). 4. Their ages will be ranged from 40 to 60 years old. 5. Their BMI will be less than 30 Kg/m2. 1. Patients with any other chronic chest diseases as (COPD and bonchiectasis). 2. Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension). 3. Smokers. 4. Patient with oxygen support. 5. Musculoskeletal/ neurological limitations to exercise. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/01/2024 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
Ahmed Elzayat Cairo 8655 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ventilatory functions (DLCo, FVC, FEV1) Before and after 10weeks of the intervention
Secondary Outcome The quality of life before and after 10 weeks of the intervention
Secondary Outcome Fibrosis grading using chest CT scan before and after 10 weeks of the intervention
Secondary Outcome Functional capacity using Bruce treadmill incremental exercise test (V̇O2 max estimation) before and after 10 weeks of the intervention
Secondary Outcome Dyspnea using Modified Borg Dyspnea Scale before and after 12 weeks of the intervention
Secondary Outcome Fibrosis measuring using Serum Krebs von den Lungen-6 (KL-6) measurement before and after 10 weeks of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Mahalla chest hospital El Mahalla Alkobra - Shabya street El Mahalla Alkobra 31953 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Saher Lotfy Abo Ali Mahalla 12611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Saher Elgayar Abo Ali Mahalla 12611 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
saher lotfy abo ali mahala 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saher Elgayar saherlotfy020@gmail.com +201020429911 Gehad
City Postal code Country Position/Affiliation
Mahalla 31951 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elhamrawy saherelgayar@yahoo.com +201060667075 Bahr
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Public Enquiries Mohamed Gamil saher_lotfi@yahoo.com +201022429914 Bosta
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Lecturer Physical therapy for women health Faculty of Physical Therapy October University for Modern Sciences and Arts
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in chronic Post-COVID pulmonary fibrosis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party Informed Consent Form,Statistical Analysis Plan Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information