Clinical trial NCT04364685: Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients.
Official title: Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walking, Difficulty
Diabetes Mellitus, Type 2
Hemoglobin; Hb-SC
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 66
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of two groups, one control group (Normal Walking) and experimental group (sand walking).
Primary purpose: TREATMENT

Brief summary: Type 2 Diabetes Meletus(T2DM) is a global health concern. The incidence of T2DM globally is increasing exponentially partly due to unhealthy food habits and sedentary life style.exercise and nutritional intervention is long being reported to improve glycemic control and improve quality of life among individuals with T2DM.

Moderate intensity of walking for 30 minutes is proven to regulate good metabolic control. however, in over weight elderly individuals, joint pain or arthritis walking be a challenging task. therefore, walking on sand which is reported to be easy on joints would be a alternative for those patients.

Detailed description: Uncontrolled T2DM has shown to cause multiple complications and alter the normal physiological process of the body. Prompt dietary management and regular exercises are reported to improve blood glucose homeostasis and eventually improve the quality of life. Physical activity such as regular walking is associated with multiple physical and psychological benefits. Walking and a healthy diet is a cornerstone in the treatment of T2DM. Several studies have shown positive short-term effects of walking in T2DM. Combination of walking and weight training is reported to cause cardiovascular adaptations, muscle hypertrophy, increased capillary density in the muscles of patients with T2DM as well as in healthy people. Furthermore, 30 minutes of brisk walking has shown to improve blood glycemic metabolism and reduces cardiovascular risk factors, such as high blood pressure, lipid disorders, and fat mass buildup. However, the elderly with mild to moderate arthritic changes especially in knee joints make walking a bit more challenging. Sand walking would be the best alternative than firm surface walking with less joint reaction forces. To the best of our knowledge, scientific literature lacks evidence about the effect of sand walking combined with individualized dietary intervention in T2DM. Therefore, the purpose of this study was to compare the effect of sand walking as compared to normal walking on glycemic metabolism, weight, and quality of life in T2DM. The Investigators hypothesize that SW would result in better health benefits than NW in T2DM.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Type 2 Diabetes for past 1 year.
2. HbA1c between 7-10%.
3. BMI between 25-29.9
4. Age Between 45-75
5. Sedentary

Exclusion Criteria:

1. Diabetic Neuropathy
2. Active Smoker
3. Musculoskeletal conditions
4. Cardiovascular conditions

Primary outcomes:
measure: HbA1c
timeFrame: 16 weeks
Secondary outcomes:
measure: BMI
timeFrame: 16 weeks
measure: Waist Circumference
timeFrame: 2 years
measure: Quality of life-39
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Al Majma'ah
country: Saudi Arabia
facility: King Khalid Hospital
state: Riyadh
Study officials:
References: