Diabetes Mellitus, Type 2NCT04937296
Effects of Home-based Physical Activity in Saudi Arabian Type-2 Diabetes Mellitus Patients.
A study testing Physical activity in people with Diabetes Mellitus, Type 2, run by Jonathan Sinclair at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Jan 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Physical activity, Usual care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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 careOther
Usual care.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Not described Receives: Other: Usual care |
| Physical activity | Experimental | Not described Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (33)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Physical fitness
Physical fitness will be examined via the Chester Step test.
Measured: Baseline
Physical fitness
Physical fitness will be examined via the Chester Step test.
Measured: 12 weeks
Physical fitness
Physical fitness will be examined via the Chester Step test.
Measured: 24 weeks
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Measured: Baseline
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Measured: 12 weeks
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Measured: 24 weeks
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: Baseline
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: 12 weeks
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: 24 weeks
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: Baseline
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: 12 weeks
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Body mass
Body mass in kg measured via an electric scale.
Measured: Baseline
Body mass
Body mass in kg measured via an electric scale.
Measured: 12 weeks
Body mass
Body mass in kg measured via an electric scale.
Measured: 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.
Measured: Baseline
Body mass index
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Measured: 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.
Measured: 24 weeks
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Measured: Baseline
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Measured: 12 weeks
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start12 Jan 2022
- Primary completion30 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Sinclair
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hertfordshire, University of Jazan
- Responsible party
- Sponsor-investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937296
- Sponsor's protocol ID
- Home based physical activity
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04937296
- Acronym / sponsor ID
- Home based physical activity
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jonathan SinclairUniversity, hospital or other
- Collaborators
- University of Hertfordshire, University of Jazan
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Other: Usual care |
| Physical activity | Experimental | Behavioral: Physical activity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityParticipants 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. | Behavioural | Physical activity |
| Usual careUsual care. | Other | Usual care |
Primary outcome
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.
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.
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.
33 secondary outcomes
WHO Well-Being Index (WHO-5)
Time frame: Baseline
WHO Well-Being Index (WHO-5)
Time frame: 12 weeks
WHO Well-Being Index (WHO-5)
Time frame: 24 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 24 weeks
Physical fitness
Time frame: Baseline
Physical fitness
Time frame: 12 weeks
Physical fitness
Time frame: 24 weeks
Fasting glucose
Time frame: Baseline
Fasting glucose
Time frame: 12 weeks
Fasting glucose
Time frame: 24 weeks
Systolic blood pressure
Time frame: Baseline
Systolic blood pressure
Time frame: 12 weeks
Systolic blood pressure
Time frame: 24 weeks
Diastolic blood pressure
Time frame: Baseline
Diastolic blood pressure
Time frame: 12 weeks
Diastolic blood pressure
Time frame: 24 weeks
Lipid profile
Time frame: Baseline
Lipid profile
Time frame: 12 weeks
Lipid profile
Time frame: 24 weeks
Body mass
Time frame: Baseline
Body mass
Time frame: 12 weeks
Body mass
Time frame: 24 weeks
Body mass index
Time frame: Baseline
Body mass index
Time frame: 12 weeks
Body mass index
Time frame: 24 weeks
Triglyceride-glucose index
Time frame: Baseline
Triglyceride-glucose index
Time frame: 12 weeks
Triglyceride-glucose index
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
Related trials for Diabetes Mellitus, Type 2
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Diabetes Mellitus, Type 2, run by Jonathan Sinclair at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBA1c (Glycated hemoglobin) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.