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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Usual care; Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jazan, Saudi Arabia
    • Jazan Diabetes Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual care	Other: Usual care; Usual care.
Experimental: Physical activity	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jonathan Sinclair
• Collaborators: University of Hertfordshire; Jazan University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Home based physical activity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No