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

June 27, 2023 updated by: Jonathan Sinclair

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
12 weeks
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.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
12 weeks
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.
24 weeks
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.
Baseline
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.
12 weeks
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.
24 weeks
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.
Baseline
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.
12 weeks
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.
24 weeks
Physical fitness
Time Frame: Baseline
Physical fitness will be examined via the Chester Step test.
Baseline
Physical fitness
Time Frame: 12 weeks
Physical fitness will be examined via the Chester Step test.
12 weeks
Physical fitness
Time Frame: 24 weeks
Physical fitness will be examined via the Chester Step test.
24 weeks
Fasting glucose
Time Frame: Baseline
Fasting glucose levels will be examined via a venous blood sample.
Baseline
Fasting glucose
Time Frame: 12 weeks
Fasting glucose levels will be examined via a venous blood sample.
12 weeks
Fasting glucose
Time Frame: 24 weeks
Fasting glucose levels will be examined via a venous blood sample.
24 weeks
Systolic blood pressure
Time Frame: Baseline
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Baseline
Systolic blood pressure
Time Frame: 12 weeks
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
12 weeks
Systolic blood pressure
Time Frame: 24 weeks
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
24 weeks
Diastolic blood pressure
Time Frame: Baseline
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Baseline
Diastolic blood pressure
Time Frame: 12 weeks
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
12 weeks
Diastolic blood pressure
Time Frame: 24 weeks
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
24 weeks
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.
Baseline
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.
12 weeks
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.
24 weeks
Body mass
Time Frame: Baseline
Body mass in kg measured via an electric scale.
Baseline
Body mass
Time Frame: 12 weeks
Body mass in kg measured via an electric scale.
12 weeks
Body mass
Time Frame: 24 weeks
Body mass in kg measured via an electric scale.
24 weeks
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.
Baseline
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.
12 weeks
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.
24 weeks
Triglyceride-glucose index
Time Frame: Baseline
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Baseline
Triglyceride-glucose index
Time Frame: 12 weeks
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
12 weeks
Triglyceride-glucose index
Time Frame: 24 weeks
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jonathan Sinclair

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Hertfordshire
Jazan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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