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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04937296
• Other study ID #: Home based physical activity
• Status: Completed
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: University of Central Lancashire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 1, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Physical activity
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.

Other:
• Usual care
Usual care.

Locations

Country	Name	City	State
Saudi Arabia	Jazan Diabetes Centre	Jazan

Sponsors (3)

Lead Sponsor	Collaborator
Jonathan Sinclair	Jazan University, University of Hertfordshire

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Physical fitness	Physical fitness will be examined via the Chester Step test.	Baseline
Secondary	Physical fitness	Physical fitness will be examined via the Chester Step test.	12 weeks
Secondary	Physical fitness	Physical fitness will be examined via the Chester Step test.	24 weeks
Secondary	Fasting glucose	Fasting glucose levels will be examined via a venous blood sample.	Baseline
Secondary	Fasting glucose	Fasting glucose levels will be examined via a venous blood sample.	12 weeks
Secondary	Fasting glucose	Fasting glucose levels will be examined via a venous blood sample.	24 weeks
Secondary	Systolic blood pressure	Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	Baseline
Secondary	Systolic blood pressure	Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	12 weeks
Secondary	Systolic blood pressure	Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	24 weeks
Secondary	Diastolic blood pressure	Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	Baseline
Secondary	Diastolic blood pressure	Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	12 weeks
Secondary	Diastolic blood pressure	Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Body mass	Body mass in kg measured via an electric scale.	Baseline
Secondary	Body mass	Body mass in kg measured via an electric scale.	12 weeks
Secondary	Body mass	Body mass in kg measured via an electric scale.	24 weeks
Secondary	Body mass index	Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.	Baseline
Secondary	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
Secondary	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
Secondary	Triglyceride-glucose index	The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.	Baseline
Secondary	Triglyceride-glucose index	The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.	12 weeks
Secondary	Triglyceride-glucose index	The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.	24 weeks