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.: PACTR202306601940612 Date of Approval: 22/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of treadmill ambulatory training on glucose control and blood pressure in persons with type 2 diabetes: a pilot study
Official scientific title Effect of treadmill ambulatory training on glucose control and blood pressure in persons with type 2 diabetes: a pilot study
Brief summary describing the background and objectives of the trial Exercise has health-enhancing impacts such as positive effects on symptoms, blood lipids, blood pressure, cardiovascular risk factor, quality of life, glycemic control and participation in daily life [1-3]. However, participation in regular physical activity is low among persons with type 2 diabetes compared to those without the diabetes [4,5]. Most recommendations for persons with type 2 diabetes are for a minimum 150 minutes per week of moderate-intensity (50-70% of maximum heart rate) aerobic exercise done with two days’ interval or 3 days/week [6,7]. This time commitment is in addition to all of the other self-care activities recommended for persons with diabetes. Consequently, a lack of time is often cited as a reason by persons with type 2 diabetes for not exercising [20]. These recommendations may thus not be practical and appealing creating an unattainable target for people with type 2 diabetes. This highlights the need for achievable targets to motivate persons with type 2 diabetes to engage in exercise. A short duration norm intensity aerobic training could be central to the adoption and maintenance of physical activity behaviour. Exercising for a shorter duration would be perceived as achievable and can improve motivation to remain active. However, the potential of a short duration moderate intensity aerobic training to improve blood glucose and blood pressure in persons with type 2 diabetes have not been explored. This could be particularly beneficial for persons with type 2 diabetes who are non exercises, physically inactive or for whom lack of time is barrier to engaging an active lifestyle. In Ghana, persons with type 2 diabetes are mostly managed with medication and diet interventions [4], with physical activity and exercise rare interventions for the management of type 2 diabetes. Therefore, the aim of this study was to investigate whether a 20-minute moderate intensity (60% target heart rate) ambulatory treadmill exercise twice weekly could improve blood glucose and blood pressure in persons with type 2 diabetes from a major tertiary hospital in Ghana.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/04/2021
Actual trial start date 01/04/2021
Anticipated date of last follow up 30/07/2021
Actual Last follow-up date 30/07/2021
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 20
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ambulatory exercise The training sessions were performed at 60% THR, determined conform. The training group received a 4-week ambulation training program with a frequency of two times a week with a duration of 20 minutes. 20 minutes twice weekly for 4 weeks Participants in the training group familiarized to the training set-up with two 5-min familiarization trials on a motor driven treadmill (Enraf Nonius, The Netherlands). After the familiarization trail participants performed a submaximal test to determine the required velocity, which elicited an intensity of 60% Target Heart Rate (THR) determined conform [23]. The initial velocity was 1m·s−1 and increased by 0.5m·s−1 every 30sec until an intensity of 60% THR was elicited. The test was terminated after 1min at the 60% THR. The training group received a 4-week ambulatory training on a motor driven treadmill (two times a week at 60% THR; details provided in the next section). Post-tests were conducted at the same time of the day, and on the same day of the week, 4 weeks after the pre-tests were completed. All participants were asked to maintain their regular daily physical activity pattern and diet during the study period. 10
Control Group Control Group No intervention No intervention The control group did not receive any training. Post-tests were conducted at the same time of the day, and on the same day of the week, 4 weeks after the pre-tests were completed. All participants were asked to maintain their regular daily physical activity pattern and diet during the study period. The control group was then given the opportunity to undertake the training after the study. 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were excluded from the study if they were not able to complete the questionnaire, even with help, or had comorbid conditions that may influence understanding or answering of the questionnaires. Informed written consent was obtained from eligible participants. Criteria for inclusion were people with type 2 diabetes for at least a year, aged 18 years and older, not currently or recently (in the previous 12 months) engaged in a physical activity programme, ambulatory (with or without assistive device). Adult: 19 Year-44 Year 18 Year(s) 80 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 31/03/2021 Research Ethics Committee of the University of Health and Allied Sciences
Ethics Committee Address
Street address City Postal code Country
Ho Highway Ho PMB31 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood glucose Pre- and 4-weeks post-intervention
Secondary Outcome Blood pressure Pre- and 4-weeks post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ho Teaching Hospital Hospital Road Ho Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Hospital Road Ho Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Hospital Road Ho Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ulric Abonie ulric.abonie@northumbria.a.uk +4401912156135 Hospital Road
City Postal code Country Position/Affiliation
Ho Ghana Assistant Professor
Role Name Email Phone Street address
Principal Investigator Raphael Addo addoraphael100@gmail.com +2335463247587 Hospital Road
City Postal code Country Position/Affiliation
Ho Ghana Researcher
Role Name Email Phone Street address
Public Enquiries Laureen Kumah kumahlaureen47@gmail.com +233558856226 Hospital Road
City Postal code Country Position/Affiliation
Ho Ghana Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD is available and shared. See the results section below for details. Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD is available see results for details. Data is openly available to anyone who request from rec@uhas.edu.gh
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/06/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/06/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information