Clinical trial NCT04937296: Effects of Home-based Physical Activity in Saudi Arabian Type-2 Diabetes Mellitus Patients.
Official title: Effects of a Home-based Physical Activity Programme on Blood Biomarkers and Health-related Quality of Life Indices in Saudi Arabian Type-2 Diabetes Mellitus Patients: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
Collaborators: name: University of Hertfordshire
name: University of Jazan
First posted: 2021-06-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The World Health Organization ranks Saudi Arabia as having the 7th highest rate of type-2 diabetes in the world. This therefore makes diabetes the most challenging health problem facing Saudi Arabia. Importantly, physical activity has been shown to improve disease symptoms and overall health in patients with type-2 diabetes. However, findings relating to the prevalence of physical inactivity in the Saudi population confirm that a sedentary lifestyle is on the rise, within physical inactivity levels in adults being 80.5%. Therefore, interventions aimed at reducing physical inactivity using bespoke modalities pertinent to Saudi Arabia are clearly warranted.

The purpose of this research project is to undertake a feasibility randomised control trial, examining the effects of a 12-week home-based physical activity programme on HbA1c, blood lipids, fasting glucose and other indices of health-related quality of life in Saudi Arabian adults with type-2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Clinically established diagnosis of type-2 diabetes for at least 12 months
* Previously sedentary
* Knowledgeable about hypoglycemia
* Aged over 18 years
* Capacity to give informed consent.

Exclusion Criteria:

* Cognitive impairment precluding consent or participation
* Pregnancy
* Additional medical conditions that prevent safe physical activity (e.g. severe arthritis or advanced heart failure)
* Enrolment in any other clinical trial designed to influence type-2 diabetes symptoms.

Primary outcomes:
measure: HBA1c (Glycated hemoglobin)
timeFrame: Baseline
measure: HBA1c (Glycated hemoglobin)
timeFrame: 12 weeks
measure: HBA1c (Glycated hemoglobin)
timeFrame: 24 weeks
Secondary outcomes:
measure: WHO Well-Being Index (WHO-5)
timeFrame: Baseline
measure: WHO Well-Being Index (WHO-5)
timeFrame: 12 weeks
measure: WHO Well-Being Index (WHO-5)
timeFrame: 24 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 24 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 24 weeks
measure: Physical fitness
timeFrame: Baseline
measure: Physical fitness
timeFrame: 12 weeks
measure: Physical fitness
timeFrame: 24 weeks
measure: Fasting glucose
timeFrame: Baseline
measure: Fasting glucose
timeFrame: 12 weeks
measure: Fasting glucose
timeFrame: 24 weeks
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Systolic blood pressure
timeFrame: 24 weeks
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: 12 weeks
measure: Diastolic blood pressure
timeFrame: 24 weeks
measure: Lipid profile
timeFrame: Baseline
measure: Lipid profile
timeFrame: 12 weeks
measure: Lipid profile
timeFrame: 24 weeks
measure: Body mass
timeFrame: Baseline
measure: Body mass
timeFrame: 12 weeks
measure: Body mass
timeFrame: 24 weeks
measure: Body mass index
timeFrame: Baseline
measure: Body mass index
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 24 weeks
measure: Triglyceride-glucose index
timeFrame: Baseline
measure: Triglyceride-glucose index
timeFrame: 12 weeks
measure: Triglyceride-glucose index
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan Diabetes Centre
Study officials:
References: