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.: PACTR202005904039357 Date of Approval: 20/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title IMPACT OF INCENTIVE SPIROMETRY ON RESPIRATORY IMPAIRMENTS
Official scientific title IMPACT OF INSPIRATORY VS EXPIRATORY INCENTIVE SPIROMETRY ON OBSTRUCTIVE, RESTRICTIVE AND MIXED VENTILATORY IMPAIRMENTS
Brief summary describing the background and objectives of the trial The purpose of this study is to investigate the efficacy of inspiratory vs expiratory incentive spirometry on obstructive, restrictive and mixed ventilatory impairments Incentive Spirometry (IS) is a technique designed to assist patient in achieving a pre-set volume or air flow, the volume is determined from predicted values or baseline measurements, it is simple and relatively safe procedure (Cairo and Mosby, 2013). Studies have compared flow and volume-oriented Incentive spirometry, flow- oriented devices was reported to impose more work of breathing and increase muscular activity of the upper chest, while the volume- oriented devices was found to reduce the work of breathing and improve diaphragmatic activity (Agostini and Singh, 2009). Exercise capacity and tolerance are considered the most important factor in the assessment of the clinical condition and prognosis of patients. The Six-Minute Walk Test is the most frequently used clinical tool in research to assess the functional status of patients with cardiac and pulmonary disease (Zielinska, 2013). Even though randomized controlled trials have indicated the efficacy of Incentive Spirometry during pulmonary rehabilitation, none has compared the relationship between inspiratory and expiratory type of incentive spirometer on the various type of ventilatory impairments. This study is therefore designed to compare a 12-week efficacy inspiratory vs expiratory incentive spirometry on obstructive, restrictive and mixed type of ventilatory impairment.
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 01/09/2020
Actual trial start date
Anticipated date of last follow up 01/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Will be available upon study completion
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Inspiratory Incentive Spirometry for Obstructive impairments 3 times per week for 12 weeks 10 minutes per session The participants will be required to breathe in the upright position before commencing the exercise using a respiration method that is best convenient for them, thereafter a volume-incentive spirometer (Coach 2 device) which enables the patient to inhale air through a mouthpiece and corrugated tubing attached to a plastic bellows will be used for inspiratory exercise with the volume of air displaced indicated on a scale located on the device enclosure. After the patient has achieved the maximum volume, the individual is instructed to hold this volume constant for 3 to 5 seconds (Cairo and Mosby, 2013). The exercise will be repeated three times to complete one set, a total of three sets will be performed up to a maximum of 10 attempts. One minute of rest will be given between sets to reduce muscular fatigue. The procedure will be stopped whenever the subjects felt dizziness 6
Experimental Group Inspiratory incentive spirometry for restrictive impairments 3 times per week for 12 weeks 10 minutes per session The participants will be required to breathe in the upright position before commencing the exercise using a respiration method that is best convenient for them, thereafter a volume-incentive spirometer (Coach 2 device) which enables the patient to inhale air through a mouthpiece and corrugated tubing attached to a plastic bellows will be used for inspiratory exercise with the volume of air displaced indicated on a scale located on the device enclosure. After the patient has achieved the maximum volume, the individual is instructed to hold this volume constant for 3 to 5 seconds (Cairo and Mosby, 2013). The exercise will be repeated three times to complete one set, a total of three sets will be performed up to a maximum of 10 attempts. One minute of rest will be given between sets to reduce muscular fatigue. The procedure will be stopped whenever the subjects felt dizziness 6
Experimental Group Inspiratory incentive Spirometry for mixed impairments 3 times per week for 12 weeks 10 minutes per session The participants will be required to breathe in the upright position before commencing the exercise using a respiration method that is best convenient for them, thereafter a volume-incentive spirometer (Coach 2 device) which enables the patient to inhale air through a mouthpiece and corrugated tubing attached to a plastic bellows will be used for inspiratory exercise with the volume of air displaced indicated on a scale located on the device enclosure. After the patient has achieved the maximum volume, the individual is instructed to hold this volume constant for 3 to 5 seconds (Cairo and Mosby, 2013). The exercise will be repeated three times to complete one set, a total of three sets will be performed up to a maximum of 10 attempts. One minute of rest will be given between sets to reduce muscular fatigue. The procedure will be stopped whenever the subjects felt dizziness 6
Experimental Group Expiratory incentive spirometry for Obstructive impairments 3 times per week for 12 weeks 10 minutes per session The participants will be required to breathe in the upright position before commencing the exercise using a respiration method that is best convenient for them. They will be asked to breathe in air through the nose to the maximum then breathe out into the balloon at the maximum rate and maintain this state for one second (Kim, 2012). They will be required to immediately close the mouth of the balloon with their fingers, breathe in to the maximum once again, and then breathe out into the balloon. The balloon-blowing exercise will be performed two times at maximum balloon-blowing over one minute. The exercise will be repeated three times to complete one set, a total of three sets will be performed up to a maximum of 10 attempts. One minute of rest will be given between sets to reduce muscular fatigue. 6
Experimental Group Expiratory incentive Spirometry for Restrictive impairments 3 times per week for 12 weeks 10 minutes per session the participants will be required to breathe in the upright position before commencing the exercise using a respiration method that is best convenient for them. They will be asked to breathe in air through the nose to the maximum then breathe out into the balloon at the maximum rate and maintain this state for one second (Jin-seop, 2012). They will be required to immediately close the mouth of the balloon with their fingers, breathe in to the maximum once again, and then breathe out into the balloon. The balloon-blowing exercise will be performed two times at maximum balloon-blowing over one minute. The exercise will be repeated three times to complete one set, a total of three sets will be performed up to a maximum of 10 attempts. One minute of rest will be given between sets to reduce muscular fatigue. 6
Experimental Group Expiratory incentive spirometry for mixed impairments 3 times per week for 12 weeks 10 minutes per session the participants will be required to breathe in the upright position before commencing the exercise using a respiration method that is best convenient for them. They will be asked to breathe in air through the nose to the maximum then breathe out into the balloon at the maximum rate and maintain this state for one second (Jin-seop, 2012). They will be required to immediately close the mouth of the balloon with their fingers, breathe in to the maximum once again, and then breathe out into the balloon. The balloon-blowing exercise will be performed two times at maximum balloon-blowing over one minute. The exercise will be repeated three times to complete one set, a total of three sets will be performed up to a maximum of 10 attempts. One minute of rest will be given between sets to reduce muscular fatigue. 6
Control Group Placebo for Obstructive impairments 3 times per week for 12 weeks 10 minutes per session Musculoskeletal assessment and counselling on respiratory impairments. 6 Placebo
Control Group Placebo for Restrictive impairments 3 times per week for 12 weeks 10 minutes per week. Musculoskeletal assessment and counselling on respiratory impairments 6 Placebo
Control Group Placebo for mixed impairments 3 time per week for 12 weeks 10 minutes Musculoskeletal assessment and counselling on respiratory impairments 6 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Individuals above the Age of 40 ● Individuals with COPD of greater than 6 months duration ● Individuals with Respiratory impairment attending respiratory clinic of Lagos State University Teaching Hospital will participate in the study. ● Those on cardiac pacemaker ● Those with cardiac conditions ● Those with Asthma ● Those on supplemental oxygen therapy ● Those with psychological disorders ● Those that are below 40 years. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 03/12/2020 Lagos State University Teaching Hospital Health Research and Ethics Committee.
Ethics Committee Address
Street address City Postal code Country
1-3 Oba Akinjobi way, Ikeja, Lagos Lagos 100271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pulmonary Function Test Pre and Post Intervention
Secondary Outcome Six minute walk test Fortnightly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-3 OBA AKINJOBI WAY, IKEJA, LAGOS. LAGOS Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
AWOLOLA ENIOLA OLADEJO 1 Ojelabi Awolola Street, Onike-Yaba,Lagos LAGOS 100213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Awolola Eniola Oladejo 1 OJELABI AWOLOLA STREET, ONIKE-YABA LAGOS 100213 Nigeria SELF FUNDED
COLLABORATORS
Name Street address City Postal code Country
Sonill Maharaj Varsity drive, Westville KwazuluNatal 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ENIOLA AWOLOLA ptoladejo@physiomedicare.org +2348056333106 1 Ojelabi Awolola Street, Onike-Yaba,Lagos
City Postal code Country Position/Affiliation
Lagos 100213 Nigeria Doctoral student
Role Name Email Phone Street address
Public Enquiries Sonill Maharaj maharajss@ukzn.ac.za +27834611413 Varsity drive,
City Postal code Country Position/Affiliation
KwazuluNatal 4000 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Eniola Awolola ptoladejo@physiomedicare.org +2348056333106 1 Ojelabi Awolola Street, Onike-Yaba,Lagos
City Postal code Country Position/Affiliation
Lagos 100213 Nigeria Doctoral Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data are all the informations that will be obtained from participants in the course of this study. The components of IPD for this study are the pulmonary variables and six minutes walk test results Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol All data will be kept and shared for a period of 5 years. The records will be destroyed after 5 years. Data obtained will be kept under lock and key, transferred and stored in excel sheet format, thereafter the records will be password protected on a computer domicile at the department of Physiotherapy, college of health sciences, University of Kwazulu-Natal. Only the researcher will have access to the records.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Will be available upon commencement of the study 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