Effects of Home-based Physical Activity in Saudi Arabian Type-2 Diabetes Mellitus Patients.
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Physical activity
Usual care
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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.
Sites / Locations
- Jazan Diabetes Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Usual care
Physical activity
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Physical fitness
Physical fitness will be examined via the Chester Step test.
Physical fitness
Physical fitness will be examined via the Chester Step test.
Physical fitness
Physical fitness will be examined via the Chester Step test.
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
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.
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.
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.
Body mass
Body mass in kg measured via an electric scale.
Body mass
Body mass in kg measured via an electric scale.
Body mass
Body mass in kg measured via an electric scale.
Body mass index
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Body mass index
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Body mass index
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Full Information
NCT ID
NCT04937296
First Posted
June 14, 2021
Last Updated
June 27, 2023
Sponsor
Jonathan Sinclair
Collaborators
University of Hertfordshire, Jazan University
1. Study Identification
Unique Protocol Identification Number
NCT04937296
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan Sinclair
Collaborators
University of Hertfordshire, Jazan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Title
Physical activity
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care.
Primary Outcome Measure Information:
Title
HBA1c (Glycated hemoglobin)
Description
Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.
Time Frame
Baseline
Title
HBA1c (Glycated hemoglobin)
Description
Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.
Time Frame
12 weeks
Title
HBA1c (Glycated hemoglobin)
Description
Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
WHO Well-Being Index (WHO-5)
Description
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.
Time Frame
Baseline
Title
WHO Well-Being Index (WHO-5)
Description
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.
Time Frame
12 weeks
Title
WHO Well-Being Index (WHO-5)
Description
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.
Time Frame
24 weeks
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Baseline
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
12 weeks
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
24 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
12 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
24 weeks
Title
Physical fitness
Description
Physical fitness will be examined via the Chester Step test.
Time Frame
Baseline
Title
Physical fitness
Description
Physical fitness will be examined via the Chester Step test.
Time Frame
12 weeks
Title
Physical fitness
Description
Physical fitness will be examined via the Chester Step test.
Time Frame
24 weeks
Title
Fasting glucose
Description
Fasting glucose levels will be examined via a venous blood sample.
Time Frame
Baseline
Title
Fasting glucose
Description
Fasting glucose levels will be examined via a venous blood sample.
Time Frame
12 weeks
Title
Fasting glucose
Description
Fasting glucose levels will be examined via a venous blood sample.
Time Frame
24 weeks
Title
Systolic blood pressure
Description
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time Frame
Baseline
Title
Systolic blood pressure
Description
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time Frame
12 weeks
Title
Systolic blood pressure
Description
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time Frame
24 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time Frame
Baseline
Title
Diastolic blood pressure
Description
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time Frame
12 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time Frame
24 weeks
Title
Lipid profile
Description
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.
Time Frame
Baseline
Title
Lipid profile
Description
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.
Time Frame
12 weeks
Title
Lipid profile
Description
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.
Time Frame
24 weeks
Title
Body mass
Description
Body mass in kg measured via an electric scale.
Time Frame
Baseline
Title
Body mass
Description
Body mass in kg measured via an electric scale.
Time Frame
12 weeks
Title
Body mass
Description
Body mass in kg measured via an electric scale.
Time Frame
24 weeks
Title
Body mass index
Description
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Time Frame
Baseline
Title
Body mass index
Description
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Time Frame
12 weeks
Title
Body mass index
Description
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Time Frame
24 weeks
Title
Triglyceride-glucose index
Description
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Time Frame
Baseline
Title
Triglyceride-glucose index
Description
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Time Frame
12 weeks
Title
Triglyceride-glucose index
Description
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Jazan Diabetes Centre
City
Jazan
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Effects of Home-based Physical Activity in Saudi Arabian Type-2 Diabetes Mellitus Patients.
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