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.: PACTR202201548823946 Date of Approval: 26/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CORRELATION BETWEEN SMOKING, SERUM SEROTONIN LEVEL, PERIPHERAL FATIGUE OF KNEE EXTENSORS AND KNEE PROPRIOCEPTION: CROSS-SECTIONAL STUDY
Official scientific title CORRELATION BETWEEN SMOKING, SERUM SEROTONIN LEVEL, PERIPHERAL FATIGUE OF KNEE EXTENSORS AND KNEE PROPRIOCEPTION: CROSS-SECTIONAL STUDY
Brief summary describing the background and objectives of the trial PURPOSE: This study will be conducted to investigate the correlation of serum cotinine level (the metabolite of nicotine), serum serotonin level, peripheral fatigue of Knee extensors and Proprioception of the Knee. BACKGROUND: Smoking is a bad habit that is destructive to our life; it is a noteworthy problem regarding general well-being that has a huge financial and additionally heath sway (Goldberg et al., 2000). Worldwide, tobacco use causes nearly six million deaths per year, and current trends show that tobacco use will cause more than eight million deaths annually by 2030, and on average smokers die 10 years earlier than nonsmokers (WHO, 2011, Jha et al., 2013). Form the available literature , the inter-relationships between cotinine level, serotonin level, fatigue of knee extensors and knee proprioception have not been reported. In addition, there is absence of a significant correlation between cotinine levels and fatigability of the muscle (Wüst et al., 2008). The present study is directed to correlate serum cotinine level, serum serotonin level, peripheral fatigue of knee extensors and knee proprioception. HYPOTHESES: There will be no statistical significant correlation between serum cotinine level, serum serotonin level, peripheral fatigue of knee extensors and knee proprioception RESEARCH QUESTION: This study will answer the following question: Is there a correlation between smoking, serum serotonin level, peripheral fatigue of knee extensors, and knee proprioception?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/03/2022
Actual trial start date
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Blood samples analysis and bilateral Knee proprioception analysis by Biodex One test for each participant before and after knee extensors muscles fatigue Subjects in the study will be consisted of heavy, moderate and non-smokers. To study the relationship between serum cotinine level, serum serotonin level, bilateral peripheral fatigue of knee extensors and knee proprioception. Blood samples would be taken and fatigue susceptibility would be measured by calculating the fatigue index of knee extensors. Bilateral Knee proprioception would be evaluated using Biodex dynamometer. 20
Control Group Investigation of nonsmokers participants One blood samples analysis before and after knee extensors muscles fatigue is done the relationship between serum cotinine level, serum serotonin level, bilateral peripheral fatigue of knee extensors and knee proprioception. Blood samples would be taken and fatigue susceptibility would be measured by calculating the fatigue index of knee extensors. Bilateral Knee proprioception would be evaluated using Biodex dynamometer. 20 Dose Comparison
Experimental Group Blood samples analysis and bilateral Knee proprioception analysis by Biodex for heavy smokers One test for each participant before and after knee extensors muscles fatigue Subjects in the study will be consisted of heavy, moderate and non-smokers. To study the relationship between serum cotinine level, serum serotonin level, bilateral peripheral fatigue of knee extensors and knee proprioception. Blood samples would be taken and fatigue susceptibility would be measured by calculating the fatigue index of knee extensors. Bilateral Knee proprioception would be evaluated using Biodex dynamometer. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Subjects with age 20-45 years (WHO, 2009). 2. Body Mass Idex from 18.5- 24.9 km/m2. 3. Males Subjects only. 4. Smokers who smoked 4_5 cigarettes a day for the last 5 years. 5. Nonsmokers males with serum cotinine levels less than 10 ng/ml. 6. Light and moderate smokers with serum cotinine levels of 10–100 ng/ ml. 7. Heavy smokers with serum cotinine levels above 300 ng/ml. 8. Smoking will be restricted to cigarettes. 1. Diabetic patients 2. Patients who receive antidepressants. 3. Hypertensive patients. 4. Cardiac patients 5. Athletic patients. 6. Patients with a history of knee pain. 7. Knee Osteoarthritis. 8. Knee surgery. 9. Patients with high cholesterol levels. 9. Cardiopulmonary or cardiovascular problems. 10. A recent history of vestibular disorder, inner ear infection with associated balance. 11. Coordination problems. Adult: 19 Year-44 Year 20 Year(s) 45 Year(s) Male
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 01/05/2021 Research Ethical Committee faculty of Physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7th ElZayat street Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Cotinine and serotonin serum level will be tested laboratory using Blood samples. 2) Bilateral Knee extensors peripheral fatigue and bilateral Knee proprioception will be measured using Biodex Isokinetic dynamometer. After knee extensors peripheral fatigue is done
Secondary Outcome Effects of serum cotinine level on knee proprioception Before and after knee extensors muscles fatigue is done
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7th ELZAYAT Street GIZA 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Abd El Hameed Mohamed Ali El Tahrir Street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Cairo University Street Giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abd El Hameed Mohamed.azazy1000@gmail.com 00201067079082 El tahrir Street
City Postal code Country Position/Affiliation
Giza Egypt Physical therapist
Role Name Email Phone Street address
Scientific Enquiries Mohsen EL sayyad Mohamed.azazy1000@gmail.com 00201142663054 ElZayat street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Yasser Ramzy Mohamed.azazy1000@gmail.com 00201005251562 ElZayat street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share results of assessment outcomes . All of the individual participant data collected during the trial after deidentification Study Protocol Immediately following publication no end date Anyone who wishes to access the data , for any purpose
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