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.: PACTR201711002738361 Date of Approval: 31/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Efficacy of Inspiratory, Expiratory and Combined Respiratory Muscle Training on Pulmonary Functions and Chest Expansions in Acute Stroke
Official scientific title Comparative Efficacy of Inspiratory, Expiratory and Combined Respiratory Muscle Training on the Pulmonary Functions and Chest Expansions in Acute Stroke Survivors
Brief summary describing the background and objectives of the trial Stroke (cerebrovascular accident) is the sudden loss of neurological function caused by an interruption of the blood flow to the brain (O¿Sullivan et al, 2014). Ischaemic stroke is the most common type, affecting about 80% of individuals with stroke, and results when a clot blocks or impair blood flow, depriving the brain of essential oxygen and nutrients. Haemorrhagic stroke occurs when blood vessels rupture, causing leakage of blood in or around the brain. Pulmonary function is often impaired in individuals with stroke. Decreased lung volume, decreased pulmonary perfusion and vital capacity, and altered chest wall excursion are all common findings. The decreased respiratory output is accompanied by increased oxygen demands required during activity using altered and unfamiliar movement patterns (O¿Sullivan et al, 2014). Specific objectives i. To determine the effect of IMT on the pulmonary parameters (FEV1, FVC, FEV1/FVC, PEF) and chest expansion in acute stroke survivors. ii. To determine the effect of EMT on the pulmonary parameters (FEV1, FVC, FEV1/FVC, PEF) and chest expansion in acute stroke survivors. iii. To determine the effect of combined respiratory muscle training (IMT and EMT) on the pulmonary parameters (FEV1, FVC, FEV1/FVC, PEF) and chest expansion in acute stroke survivors. iv. To determine which of the respiratory muscle training methods (IMT, EMT, and combined respiratory muscle training) will be most effective in improving the pulmonary functions and chest expansion in acute stroke survivors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 03/04/2017
Actual trial start date 10/04/2017
Anticipated date of last follow up 22/08/2017
Actual Last follow-up date 11/09/2017
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 45
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
Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Inspiratory muscle training, Expiratory muscle training, Combined Respiratory Muscle Training daily 4weeks Inspiratory muscle strengthening, Expiratory muscle strengthening and combined 15
Experimental Group Expiratory Muscle Training daily 4weeks Participants in this group trained daily over a 4-week period. Participants performed five sets of 10 breaths with the Ultrabreathe trainer, with resting periods of 1 minute between sets (Kulnik et al, 2014). The training resistance was set at 50% of the individual¿s MEP. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Patients with a confirmed medical diagnosis of stroke (ischaemic or haemorrhagic). ii. Patients within 2 weeks of stroke onset. iii. Patients with stroke whose ages were greater than 18 years. iv. Patients with stroke who had the ability to give informed consent. v. Patients with stroke who had the ability to follow instructions and engage in study procedures. vi. Patients with stroke whose blood pressures were controlled. i. Patients with stroke who had signs of increased intracranial pressure on computed tomography (CT) scan. ii. Patients with stroke who had poorly controlled hypertension, defined as blood pressure higher than 180/100 mmHg on three or more occasions over the preceding 24 hours. iii. Patients with stroke who had myocardial infarction, angina, or acute heart failure in the preceding 3 months. iv. Patients with stroke who had pulmonary, neurologic or orthopaedic conditions adversely affecting the respiratory pump, including asthma and chronic obstructive pulmonary disease (COPD). 37 Year(s) 82 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 02/06/2017 Health Research and Ethics Committee of the Lagos University Teaching Hospital (LUTH)
Ethics Committee Address
Street address City Postal code Country
PMB, 12003, Lagos Lagos 23401 Nigeria
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 30/06/2017 Health Research and Ethics Committee of the General Hospital, Marina, Lagos (GH, Lagos) through the Lagos State Health Service Commission (HSC).
Ethics Committee Address
Street address City Postal code Country
Ganiu-smith Street Lagos 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome FEV1 24 hours after referral for physiotherapy (baseline values) 4th week post-intervention
Primary Outcome FVC 24 hours after referral for physiotherapy (baseline values) 4th week post-intervention
Primary Outcome FEV1/FVC 24 hours after referral for physiotherapy (baseline values) 4th week post-intervention
Primary Outcome PEFR 24 hours after referral for physiotherapy (baseline values) 4th week post-intervention
Primary Outcome Chest Expansion 24 hours after referral for physiotherapy (baseline values) 4th week post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital, Marina, Lagos Broad Street Lagos 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Abiodun Akanbi Adeogun 39, Doyin Omololu Street,, Alapere, Ketu Lagos Nigeria 100243 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Health Service Commission Ganiu-Smith Street Lagos 23401 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Gaji Omobolaji Tajudeen General Hospital, Broad Street, Lagos Lagos 23401 Nigeria
Umar Dolapo Kofoworola General Hospital, Broad Street, Lagos Lagos 23401 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abiodun Adeogun ptadeogun@gmail.com +2348033319845 39, Doyin Omololu Street,
City Postal code Country Position/Affiliation
Lagos 100243 Nigeria Senior Physiotherapist
Role Name Email Phone Street address
Public Enquiries Dolapo Umar dolapoumar1@gmail.com +2348132826202 General Hospital, Broad Street, Lagos
City Postal code Country Position/Affiliation
Lagos 23401 Nigeria Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Abiodun Adeogun ptadeogun@gmail.com +2348033319845 General Hospital, Broad Street, Lagos
City Postal code Country Position/Affiliation
Lagos 23401 Nigeria Senior Physiotherapist
REPORTING
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Changes to trial information