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.: PACTR202107584701552 Date of Approval: 07/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Fixed 7.5 minutes of Exercise on Blood Pressure and bod composition among Sedentary individuals who higher blood pressure ranges. in Kenya
Official scientific title The Effect of Fixed 7.5 minutes’ Moderate Intensity Exercise bouts on Blood Pressure and body composition among Sedentary Prehypertensive Adults in Western-Kenya.
Brief summary describing the background and objectives of the trial Sedentary lifestyles contribute to recent increase in non-communicable diseases in Kenya ( Ssewanyana, et al. 2018). These diseases have heavy health and economic burden. Among them, hypertension, the commonest cardiovascular disease affects 1 in 7 people globally, contributing the most mortality (Ogola, et al. 2018). It is traditionally defined as blood pressure (BP) ≥140/90 but recently included lower values of 130/80. Identifying at-higher-risk individuals early and intervening before they convert from pre-disease to full-blown disease is critical (Niiranen, et al. 2017). This state, known as prehypertension, is defined as Systolic BP ≥120-139 and/or diastolic BP ≥80-89 in ≥18 year olds after ≥2 consecutive measurements. In 2018, prehypertension prevalence in Kenya was 47% (51% for males; 46% for females) (Ogola, et al. 2018) and is expected to keep rising, with 20-33% of pre-hypertensive individuals developing full hypertension within 4 years if no preventive interventions are employed. since the first line management of prehypertension is lifestyle change targeting modifiable factors such as exercise involvement, the study aims to evaluate adherence to and BP benefits of cumulative fixed bouts of 7.5-minutes’ moderate intensity exercises performed throughout the day as opposed to the single-continuous 30-60 minute bouts among sedentary prehypertensive adults, in quest to mitigate development of full-blown hypertension.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 16/08/2020
Actual trial start date 31/08/2020
Anticipated date of last follow up 31/01/2021
Actual Last follow-up date 21/01/2021
Anticipated target sample size (number of participants) 750
Actual target sample size (number of participants) 665
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
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no intervention nil 12 weeks none 182 Uncontrolled
Experimental Group exercise three bouts of 7.5 minutes exercise 12 weeks Three bouts of 7.5 minutes each daily, exercise prescription being home-based moderate intensity exercises (jogging) that raise heart rate (HR) to 50-70% of participant’s maximal expected HR, given as 220 – (minus) age in years, or where one can talk while jogging but not sing (CDC 2015). Monitoring for adherence will entail participants wearing activity monitors (Vivoactive 4 Garmin smart watches) on select days but additionally keeping exercise logs analysed for adherence and quality control weekly. Phone calls and text reminders for exercise performances will be done weekly to ensure observance of prescriptions thus reducing attrition and cross-over effects of adopting non-prescribed exercise regimes. 231
Experimental Group exercise 30-60 minutes bouts of exercise 3 to 5 times a week 12 weeks 30-60 minutes of moderate intensity exercise performed 3 to 5 times a week, which exercise prescription shall be home-based moderate intensity exercises (jogging) that raise heart rate (HR) to 50-70% of participant’s maximal expected HR, given as 220 – (minus) age in years, or where one can talk while jogging but not sing (CDC 2015). Monitoring for adherence will entail participants wearing activity monitors (Vivoactive 4 Garmin smart watches) on select days but additionally keeping exercise logs analysed for adherence and quality control weekly. Phone calls and text reminders for exercise performances will be done weekly to ensure observance of prescriptions thus reducing attrition and cross-over effects of adopting non-prescribed exercise regimes. 252
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults of ≥18 years Weekly metabolic equivalent minutes (MET-minutes) <600 as definition for sedentary Systolic BP ≥120-139 mmHg and/or diastolicBP ≥80-89 mmHg) physical disability that may affect involvement in jogging exercises Known hear tdisease to include confirmed hypertension Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 69 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 17/03/2020 Moi teaching and Referral hospital and Moi university institutional review committee MUMTRH IREC
Ethics Committee Address
Street address City Postal code Country
P.O. BOX 3 Eldoret eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome blood pressure reduction 12 weeks
Secondary Outcome exercise adherence 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Moi teaching and referral hospital p.o. box 4606, Nandi street eldoret 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
CARTA Kitusuru Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CARTA Kitusuru nairobi Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator karani magutah kmagutah@gmail.com +254721545063 p.o. box 4606
City Postal code Country Position/Affiliation
eldoret 30100 Kenya lecturer
Role Name Email Phone Street address
Public Enquiries Catherine Okwiri irec@mtrh.go.ke +254722475227 box 3
City Postal code Country Position/Affiliation
eldoret 30100 Kenya IREC administrator
Role Name Email Phone Street address
Scientific Enquiries Eren Oyungu erenoyungu2002@yahoo.co.uk +254722344312 p.o. box 4606
City Postal code Country Position/Affiliation
eldoret 30100 Kenya head of deparment
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data collected from individual participants in this work will be de-identified and thereafter, together with data from all other participants together analyzed and reported in text, tables and figures. For whoever may need and for whichever purpose, we will make available the study Protocol, signed Informed Consent forms and de-identified data Immediately following associated manuscript publication. These will be deposited with my university digital repository available @ http://ir.mu.ac.ke:8080/xmlui/ Study Protocol within 12 months of completion open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://ir.mu.ac.ke:8080/xmlui/ 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