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

NCT ID: NCT04937296

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2023-06-01

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care.

Physical activity

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care

Usual care.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hertfordshire

OTHER

Sponsor Role: collaborator

University of Jazan

OTHER_GOV

Sponsor Role: collaborator

Jonathan Sinclair

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Sinclair

Research professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Jazan Diabetes Centre

Jizan, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

Home based physical activity

Identifier Type: -

Identifier Source: org_study_id