Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364685
• Other study ID #: MajmaahUNI
• Status: Completed
• Phase: N/A
• Start date: January 25, 2017
• Est. completion date: September 28, 2019

Study information

• Verified date: September 2020
• Source: Majmaah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 28, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hemoglobin; Hb-SC
• Mobility Limitation
• Overweight
• Walking, Difficulty

Intervention

Other:
• Walking on soft-sand
The participants are required to walking on sand for 30 minutes. Walking is self-paced.
• Walking on Levelled Surface
The Participants will be require to walk on the firm surface for 30 minutes. The participants would decide the pace of walking.

Locations

Country	Name	City	State
Saudi Arabia	King Khalid Hospital	Al Majma'ah	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Majmaah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Percentage of hemoglobin A1c	16 weeks
Secondary	BMI	Body mass index	16 weeks
Secondary	Waist Circumference	the waist circumference was measured by inch tape at the level of Anterior superior iliac spine.	2 years
Secondary	Quality of life-39	The Validated quality of life for diabetes containing 39 items and scoring on a 1-7 Likert scale.	16 weeks