NCT04937296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 14, 2021

Last Update Submit

June 27, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (33)

  • WHO Well-Being Index (WHO-5)

    Baseline

  • WHO Well-Being Index (WHO-5)

    12 weeks

  • WHO Well-Being Index (WHO-5)

    24 weeks

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline

  • Patient Health Questionnaire-9 (PHQ-9)

    12 weeks

  • +28 more secondary outcomes

Study Arms (2)

Usual care

PLACEBO COMPARATOR
Other: Usual care

Physical activity

EXPERIMENTAL
Behavioral: Physical activity

Interventions

Physical activityBEHAVIORAL

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.

Physical activity
Usual careOTHER

Usual care.

Usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jazan Diabetes Centre

Jizan, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research professor

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 24, 2021

Study Start

January 12, 2022

Primary Completion

January 30, 2023

Study Completion

June 1, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations

SA(1)