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.: PACTR202005890624077 Date of Approval: 06/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Pulmonary exercise and body position on COPD
Official scientific title Efficacy of Pulmonary exercise administered in various body positions on selected Cardiopulmonary parameters of patients with COPD
Brief summary describing the background and objectives of the trial The purpose of this study is to investigate the efficacy of pulmonary exercises administered in 3 fundamental body positions on Medical Research Council (MRC) dyspnea score, 6 minutes’ walk test, CAT score and selected cardiopulmonary variables of patients with COPD. Pulmonary rehabilitation (PR) is an evidence-based, multidisciplinary, and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities (Nici et al, 2006; Nici et al 2011; Spruit et al 2013). Education, self-management training, nutrition and psychological support are important components of PR, exercise training is the cornerstone of the PR (Carreiro et al, 2013; Spruit et al, 2013). PR has been demonstrated to increase the exercise tolerance, lower the dyspnea perception, and improve the quality of life in COPD patients, the patients’ responses to PR differ, and no improvement can be achieved in some patients (Spruit et al, 2013; Maged et al, 2016 ). According to Hornikx et al, 2013; Franssen and Rochester (2014), the presence and number of comorbidities may decrease the positive effects of PR on dyspnea perception, functional exercise capacity, and quality of life. Even though randomized controlled trials have indicated the efficacy of upper limb exercises, autogenic drainage and active cycle of breathing technique (ACBT) in pulmonary rehabilitation on COPD patients, none has considered the Impact of the pulmonary rehabilitation varied across different fundamental body positions on the pulmonary parameters of patients with COPD. This study is aimed to evaluate the 12-week efficacy of pulmonary exercises administered in Supine, 45° long sitting and 90° long sitting program on MRC dyspnea scale, 6 minutes’ walk test, CAT score, HR, RR, SBP, DBP, FVC, FEV1 and FEV1/FVC of COPD patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COPD
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 01/01/2021
Actual trial start date 02/11/2020
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
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 PR in supine position 3 times in a week 20 minutes for 12 weeks In Supine position, participant will be asked to perform pulmonary exercise for 15mins with a break of 90 seconds after every 5 minutes of pulmonary exercise. The exercise sequence will be Reciprocal pulley first, then Autogenic drainage, then ACBT, each procedure will last 5 minutes. Participants cardiovascular and pulmonary parameters will be checked before and after every pulmonary exercise. Participants MRC dyspnea score, CAT score, 6MWT will be checked fortnightly for 12 weeks. 7
Experimental Group PR in 45 degrees long sitting 3 times a week 20 minutes for 12 weeks In 45 degrees long sitting position, participant will be asked to perform pulmonary exercise for 15mins with a break of 90 seconds after every 5 minutes of pulmonary exercise. The exercise sequence will be Reciprocal pulley first, then Autogenic drainage, then ACBT, each procedure will last 5 minutes. Participants cardiovascular and pulmonary parameters will be checked before and after every pulmonary exercise. Participants MRC dyspnea score, CAT score, 6MWT will be checked fortnightly for 12 weeks. 7
Experimental Group PR 90 degrees long sitting 3 times a week 20 minutes for 12 weeks In 90 degrees long sitting position, participant will be asked to perform pulmonary exercise for 15mins with a break of 90 seconds after every 5 minutes of pulmonary exercise. The exercise sequence will be Reciprocal pulley first, then Autogenic drainage, then ACBT, each procedure will last 5 minutes. Participants cardiovascular and pulmonary parameters will be checked before and after every pulmonary exercise. Participants MRC dyspnea score, CAT score, 6MWT will be checked fortnightly for 12 weeks. 7
Control Group Placebo in Supine 3 times a week 20 minutes for 12 weeks In Supine position, participant will be asked to maintain the position while researcher perform a subjective assessment of participants musculoskeletal system. Participants will be encouraged to maintain position for 20 minutes. Participants cardiovascular and pulmonary parameters will be checked before and after every procedure. Participants MRC dyspnea score, CAT score, 6MWT will be checked fortnightly for 12 weeks. 7 Placebo
Control Group Placebo 45 degrees long sitting 3 times a week 20 minutes for 12 weeks In 45 degrees long sitting position, participant will be asked to maintain the position while researcher perform a subjective assessment of participants musculoskeletal system. Participants will be encouraged to maintain position for 20 minutes. Participants cardiovascular and pulmonary parameters will be checked before and after every procedure. Participants MRC dyspnea score, CAT score, 6MWT will be checked fortnightly for 12 weeks. 7 Placebo
Control Group Placebo 90 degrees long sitting 3 times a week 20 minutes for 12 weeks In 90 degrees long sitting position, participant will be asked to maintain the position while researcher perform a subjective assessment of participants musculoskeletal system. Participants will be encouraged to maintain position for 20 minutes. Participants cardiovascular and pulmonary parameters will be checked before and after every procedure. Participants MRC dyspnea score, CAT score, 6MWT will be checked fortnightly for 12 weeks. 7 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 COPD 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 14/10/2020 Lagos State University Teaching Hospital Health Research Ethics Committe
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 1. Lung function test FEV1, FVC, FEV1/FVC 2. Cardiovascular parameters HR, RR, SBP,DBP Lung function test and cardiovascular parameters will be measured before and after every procedure.
Secondary Outcome 1. Six-minute walk Test 6MWT 2. MRC Dyspnea scale 3. CAT score Six-minute walk Test 2. MRC Dyspnea scale 3. CAT score will be measured fortnighly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1-3 Oba Akinjobi way, Ikeja Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Eniola Awolola 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 Eniola Awolola 1 Ojelabi Awolola Street, Onike-Yaba,Lagos Lagos 100213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Sonill Sooknunan Maharaj Varsity drive, Westvile KwazuluNatal 4000 South Africa
Oluwafemi Tunde Ojo 1-3 Oba Akinjobi way, Ikeja Lagos 100271 Nigeria
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 PhD Student
Role Name Email Phone Street address
Scientific Enquiries Sonil Maharaj maharajss@ukzn.ac.za +27834611413 Varsity drive, Westville
City Postal code Country Position/Affiliation
Durban 4000 South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries Oluwafemi Ojo ojofemi911@yahoo.com +2348038344342 1-3 Oba Akinjobi way, Ikeja
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Pulmonologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data are all the informations obtained from Participants in the course of study. The components of IPD for this study are the Cardiopulmonary variables and the quality life tools. 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 All data will be kept under lock and key and transfer to excel sheet electronically on a password protected computer at the Physiotherapy department, college of Health sciences, University of Kwazulu-Natal. Only the researchers will have access to it
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://docs.google.com/spreadsheets/d/10hWnNFbG6frI_U093-ESbW80tTy2wf0f7M4nfh5Cxbk 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