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.: PACTR201912488268409 Date of Approval: 03/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Upper Body Resistance Training and Diaphragmatic Breathing on Cardiopulmonary parameters, Glycaemic index, Nicotine Dependence and Health status in Male Smokers.
Official scientific title Effect of Upper Body Resistance Training and Diaphragmatic Breathing on Cardiopulmonary parameters, Glycaemic Index, Nicotine Dependence and Health status in Male Smokers.
Brief summary describing the background and objectives of the trial Background: Smoking is the most common form of recreational drug use and it accounts for a mortality rate of 8million deaths per year. Impaired Cardiopulmonary functions, high Glycaemic index, increased Dependence on nicotine and poor quality of life have been noted as the consequences smoking. Strengthening the muscles of respiration and Upper Body may bring about improvements in their lung function, reduce nicotine dependence as well as improve quality of life of smokers, hence the purpose of this study. Aim/Objectives: The overall aim of this study is to evaluate the effect of Upper Body Resistance Training and Diaphragmatic Breathing on Cardiopulmonary parameters, Glycaemic index, Nicotine Dependence and Health Status in Male Smokers. The specific Objectives of the study include: 1. To evaluate the effect of Upper Body Resistance Training on Cardiopulmonary parameters (Blood pressure, Mean arterial Pressure), Glycaemic index, Nicotine dependence and Health status in Male Smokers. 2. To evaluate the effect of Diaphragmatic Breathing on Cardiopulmonary Parameters (Blood pressure, Mean arterial Pressure), Glycaemic index, Nicotine Dependence and Health Status in Male Smokers. 3. To compare the effect of Upper Body Resistance Training and Diaphragmatic Breathing on Cardiopulmonary Parameters (Blood pressure, Mean arterial Pressure), Glycaemic index, Nicotine Dependence and Health Status in Male Smokers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 23/09/2019
Actual trial start date 07/10/2019
Anticipated date of last follow up 27/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 55
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Upper Body Resistance Training 50 minutes three times weekly 6 weeks Intervention will begin with a 5 minute warm up stretching exercise. Upper body Resistance Training involving 5 different exercises, each lasting for 10 minutes and 1 minute rest in between exercises. Exercise will be performed for 3 sets of 10 repititions each. The exercises include: 1. Seated shoulder press exercise 2. Seated rows 3. Latissimus dorsi pull down 4. Seated chest press 5. Barbell shoulder shrug exercises Intervention will end with a 5 minute cool down stretching exercise 20
Experimental Group Diaphragmatic Exercise Group 50 minutes Diaphragmatic breathing exercise, three times weekly 6 weeks The intervention will involve 50 minutes of Diaphragmatic breathing exercise with one hand of the Therapist placed on the participant's anterior chest wall and the other hand in the upper abdomen. Participant will be asked to breath in fully against the Therapist's hand and then breath out maximally. This will be repeated severally with rest period. 20
Control Group Deep breathing exercise group 50 minutes deep breathing exercise will be performed three times weekly. 6 weeks Participant's will be seated in a chair and instructed to take in a deep breath, hold on for 1 minute and breath out all the inspired air. Procedure will be repeated severally within 50 minutes with rest period. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male Smokers within 18- 55 years Nicotine dependence of greater than 3 on the Fagerstrom test for nicotine dependence questionnaire People who smoke atleast one cigarette daily for a minimum of 1 year Smokers who have not been involved in any structured aerobic exercise in the past 3 months . Any known cardiac, respiratory impairment .Physically active individuals Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 18/09/2019 College of Medicine University of Lagos Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd floor Biomedical Engineering Block College of Medicine, University of Lagos Idi Araba Lagos Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiopulmonary parameters, Glycaemic index, Nicotine dependence End of the study
Secondary Outcome Health status End of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Lagos College of Medicine, University of Lagos, Idi- Araba Lagos Lagos 1000001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ezeugwa Chidinma Joy 23, Adeptan street, ogba Lagos Ogba Ikeja 1000001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ezeugwa Chidinma Joy Adepitan street, Ogba Ikeja Lagos Ikeja 100001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Happiness Aweto Department of Physiotherapy, College of Medicine, University of Lagos Lagos 100001 Nigeria
Dr Oluwaseun Fapojuwo Department of Physiotherapy, College of Medicine, Idi- araba Lagos Lagos 100001 Nigeria
Adeniran Funmilayo Department of Physiotherapy College of Medicine University of Lagos Lagos 100001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidinma Ezeugwa cezeugwa@unilag.edu.ng 08032242763 Adepitan Street, Ogba Lagos
City Postal code Country Position/Affiliation
Ogba Ikeja Lagos 1000001 Nigeria Postgraduate Student
Role Name Email Phone Street address
Scientific Enquiries Happiness Aweto haweto@unilag.edu.ng 07032790407 Physiotherapy Department, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior Lecturer University of Lagos
Role Name Email Phone Street address
Public Enquiries Oluwaseun Fapojuwo ofapojuwo@unilag.edu.ng 08060081382 Physiotherapy Department College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Lecturer University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Measurements of the following variables will carried out before and 6 weeks after intervention: cardiopulmonary parameters (Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure, Forced vital capacity, Forced expiratory volume in one second), Glycaemic index, Nicotine dependence and Health status. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 2weeks of actual completion of the study A link to the Excel spreed sheet containing imputed participant's data will be made available.
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