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.: PACTR201711002754229 Date of Approval: 10/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of inspiratory muscle training on selected cardiopulmonary parameters, functional capacity and glycemic control in patients with diabetes
Official scientific title Effects of inspiratory muscle training on selected cardiopulmonary parameters, functional capacity and glycemic control in patients with type 2 diabetes Mellitus
Brief summary describing the background and objectives of the trial Type 2 diabetes mellitus (T2DM) is the most common type of diabetes. It has been established that patients with T2DM suffer cardiopulmonary impairment and may present with weakness of the inspiratory muscles. There is limited evidence to support the efficacy of inspiratory muscle training in patients with T2DM. This study was therefore designed to determine the effect of inspiratory muscle training on selected cardiopulmonary parameters, functional capacity and glycemic control in patients with T2DM
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Type 2 diabetes mellitus
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 13/06/2017
Actual trial start date 27/06/2017
Anticipated date of last follow up 28/08/2017
Actual Last follow-up date 26/09/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 59
Recruitment status Stopped early/ terminated
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation by using procedures such as coin-tossing or dice-rolling 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 10 breaths per session, 5 times a day 8 weeks Inspiratory muscle training using an incentive spirometer 30
Control Group Type 2 diabetes Medication Daily 8 weeks Type 2 diabetes Medication 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with a confirmed medical diagnosis of T2DM Patients above 18 years of age Patients who have the ability to follow instructions and engage in study procedures. Patients with T2DM who had a history of Cardiorespiratory disease and chest deformities. Patients with severe complications of DM, such as neuropathy, nephropathy, and retinopathy Patients with T2DM who have had recent abdominal surgery. Patients who were cigarette Smokers. Patients involved in a structured aerobic exercise programme for the past 6 months. Patients who were pregnant. 30 Year(s) 85 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 07/06/2017 Lagos university Teaching Hospital, Health Research Ethics Committe.
Ethics Committee Address
Street address City Postal code Country
Room 107, 1st floor LUTH Administrative block Lagos 12003 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 05/06/2017 Health service commission
Ethics Committee Address
Street address City Postal code Country
1, Ganiu Smith Street, Lagos Island Lagos Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Portable spirometer Baseline (pre IMT) Post IMT (8th week)
Primary Outcome Blood glucose meter Pre IMT (Baseline) Post IMT (8th week)
Primary Outcome Six minute walk test Pre IMT (Baseline) Post IMT (8th week)
Primary Outcome Mercuty sphygmomanometer and stethoscope Pre IMT (Baseline) Post IMT (8th week)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital Lagos Broadstreet, Marina Lagos Nigeria
Department of medicine, Lagos university Teaching Hospital Idi Araba, Lagos Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Family Nigerian Airforce Base, Airport Road Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NC Obikeh Nigerian Airforce Base, Airport Road Abuja Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr H.A. Aweto Department of physiotherapy, University of Lagos. Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Esther Obikeh ibehesther@gmail.com 2347037265627 Department of Physiotherapy, College of Medicine, Univerty of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Student
Role Name Email Phone Street address
Public Enquiries Esther Obikeh ibehesther@gmail.com 2347037265627 Department of Physiotherapy, College of Medicine, Univerty of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Student
Role Name Email Phone Street address
Scientific Enquiries Esther Obikeh ibehesther@gmail.com 2347037265627 Department of Physiotherapy, College of Medicine, Univerty of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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