Effects of Home-based Physical Activity in Saudi Arabian Type-2 Diabetes Mellitus Patients.

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Physical activity; Other: Usual care

• Registration Number: NCT04937296
• Lead Sponsor: Jonathan Sinclair

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-24
• Study Start: 2022-01-12
• Primary Completion: 2023-01-30
• Status Verified: 2023-06
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity	Physical activity	-
Usual care	Usual care	-

Primary Outcome Measures

Name	Time	Method
HBA1c (Glycated hemoglobin)	24 weeks	Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.

Secondary Outcome Measures

Name	Time	Method
WHO Well-Being Index (WHO-5)	24 weeks	The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. A score of 0 represents the worst imaginable well-being and 100 represents the best imaginable well-being.
Pittsburgh Sleep Quality Index (PSQI)	24 weeks	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Physical fitness	24 weeks	Physical fitness will be examined via the Chester Step test.
Fasting glucose	24 weeks	Fasting glucose levels will be examined via a venous blood sample.
Diastolic blood pressure	24 weeks	Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Lipid profile	24 weeks	A full lipid profile will be undertaken this involves Low-density lipoprotein (LDL), High-density lipoprotein (HDL), Triglycerides and Total cholesterol levels. This will be examined via a venous blood sample.
Patient Health Questionnaire-9 (PHQ-9)	24 weeks	The Patient Health Questionnaire-9 (PHQ-9) is the depression module, which has nine questions ranging from "0" (not at all) to "3" (nearly every day). The scoring is interpreted as 0-4 no depression symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depression symptoms.
Body mass	24 weeks	Body mass in kg measured via an electric scale.
Body mass index	24 weeks	Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Triglyceride-glucose index	24 weeks	The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Systolic blood pressure	24 weeks	Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

Trial Locations

Locations (1)

Jazan Diabetes Centre; 🇸🇦 Jazan, Saudi Arabia