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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Physical activity
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual care<br> | Other: Usual care<br>* Usual care.<br>|
| Experimental: Physical activity<br> | Behavioral: Physical activity<br>* Participants will be asked to perform resistance exercises 3-times a week on alternating days for 12 weeks. Exercises will be performed with a TheraBand and will include the squat, lunge, press-up, cross body reach, reverse fly, lateral raise, biceps curl, triceps extension, frontal raise and bridge. In addition to the resistance exercises, the participants will perform aerobic exercise. They will be asked to download a specific exercise app to record the number of steps on day 1 of the intervention and participants who do not possess the required phone technology will be provided with a pedometer. They then will be asked to add 2000 steps on to their daily steps; this amount will then become their daily step goal. Once they have reached this goal on 4 out of 5 days, they will be asked to increase their new step step goal by an extra 500 per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBA1c (Glycated hemoglobin) | Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample. | Baseline | 
| HBA1c (Glycated hemoglobin) | Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample. | 12 weeks | 
| HBA1c (Glycated hemoglobin) | Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Well-Being Index (WHO-5) | 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. | Baseline | 
| WHO Well-Being Index (WHO-5) | 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. | 12 weeks | 
| WHO Well-Being Index (WHO-5) | 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. | 24 weeks | 
| Patient Health Questionnaire-9 (PHQ-9) | 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. | Baseline | 
| Patient Health Questionnaire-9 (PHQ-9) | 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. | 12 weeks | 
| Patient Health Questionnaire-9 (PHQ-9) | 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. | 24 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | 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. | Baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | 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. | 12 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | 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. | 24 weeks | 
| Physical fitness | Physical fitness will be examined via the Chester Step test. | Baseline | 
| Physical fitness | Physical fitness will be examined via the Chester Step test. | 12 weeks | 
| Physical fitness | Physical fitness will be examined via the Chester Step test. | 24 weeks | 
| Fasting glucose | Fasting glucose levels will be examined via a venous blood sample. | Baseline | 
| Fasting glucose | Fasting glucose levels will be examined via a venous blood sample. | 12 weeks | 
| Fasting glucose | Fasting glucose levels will be examined via a venous blood sample. | 24 weeks | 
| Systolic blood pressure | Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. | Baseline | 
| Systolic blood pressure | Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. | 12 weeks | 
| Systolic blood pressure | Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. | 24 weeks | 
| Diastolic blood pressure | Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. | Baseline | 
| Diastolic blood pressure | Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. | 12 weeks | 
| Diastolic blood pressure | Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm. | 24 weeks | 
| Lipid profile | 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. | Baseline | 
| Lipid profile | 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. | 12 weeks | 
| Lipid profile | 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. | 24 weeks | 
| Body mass | Body mass in kg measured via an electric scale. | Baseline | 
| Body mass | Body mass in kg measured via an electric scale. | 12 weeks | 
| Body mass | Body mass in kg measured via an electric scale. | 24 weeks | 
| Body mass index | Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature. | Baseline | 
| Body mass index | Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature. | 12 weeks | 
| Body mass index | Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature. | 24 weeks | 
| Triglyceride-glucose index | The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices. | Baseline | 
| Triglyceride-glucose index | The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices. | 12 weeks | 
| Triglyceride-glucose index | The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices. | 24 weeks |