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Completed

NCT Number: NCT04937296

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jazan Diabetes Centre

Jizan, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Behavioral

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.

Usual Care

Other

Usual care.

Primary outcomes

  1. HBA1c (Glycated hemoglobin)

    Time frame: Baseline

    Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.

  2. HBA1c (Glycated hemoglobin)

    Time frame: 12 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.

  3. HBA1c (Glycated hemoglobin)

    Time frame: 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 outcomes

  1. WHO Well-Being Index (WHO-5)

    Time frame: Baseline

    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.

  2. WHO Well-Being Index (WHO-5)

    Time frame: 12 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.

  3. WHO Well-Being Index (WHO-5)

    Time frame: 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.

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline

    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.

  5. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 12 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.

  6. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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.

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline

    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.

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 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.

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  10. Physical fitness

    Time frame: Baseline

    Physical fitness will be examined via the Chester Step test.

  11. Physical fitness

    Time frame: 12 weeks

    Physical fitness will be examined via the Chester Step test.

  12. Physical fitness

    Time frame: 24 weeks

    Physical fitness will be examined via the Chester Step test.

  13. Fasting glucose

    Time frame: Baseline

    Fasting glucose levels will be examined via a venous blood sample.

  14. Fasting glucose

    Time frame: 12 weeks

    Fasting glucose levels will be examined via a venous blood sample.

  15. Fasting glucose

    Time frame: 24 weeks

    Fasting glucose levels will be examined via a venous blood sample.

  16. Systolic blood pressure

    Time frame: Baseline

    Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  17. Systolic blood pressure

    Time frame: 12 weeks

    Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  18. Systolic blood pressure

    Time frame: 24 weeks

    Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  19. Diastolic blood pressure

    Time frame: Baseline

    Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  20. Diastolic blood pressure

    Time frame: 12 weeks

    Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  21. Diastolic blood pressure

    Time frame: 24 weeks

    Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.

  22. Lipid profile

    Time frame: Baseline

    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.

  23. Lipid profile

    Time frame: 12 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.

  24. Lipid profile

    Time frame: 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.

  25. Body mass

    Time frame: Baseline

    Body mass in kg measured via an electric scale.

  26. Body mass

    Time frame: 12 weeks

    Body mass in kg measured via an electric scale.

  27. Body mass

    Time frame: 24 weeks

    Body mass in kg measured via an electric scale.

  28. Body mass index

    Time frame: Baseline

    Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.

  29. Body mass index

    Time frame: 12 weeks

    Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.

  30. Body mass index

    Time frame: 24 weeks

    Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.

  31. Triglyceride-glucose index

    Time frame: Baseline

    The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.

  32. Triglyceride-glucose index

    Time frame: 12 weeks

    The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.

  33. Triglyceride-glucose index

    Time frame: 24 weeks

    The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.

Sponsors and collaborators

Lead sponsor

Jonathan Sinclair

Other

Collaborators

  • University of Hertfordshire
  • University of Jazan

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2021
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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