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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Walking, Difficulty; Hemoglobin; Hb-SC
• Intervention / Treatment: Other: Walking on Levelled Surface; Other: Walking on soft-sand

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Majma'ah, Riyadh, Saudi Arabia, 11952
      • King Khalid Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal Walking; The participants performed 30 minutes on levelled surface on the track and field ground. Participants performed moderate intensity walking, self paced.	Other: 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.
Experimental: Sand Walking; The participants performed supervised walking on sand on the 20 meters pathway containing soft sand.The walking on sand for 30 minutes.	Other: Walking on soft-sand; The participants are required to walking on sand for 30 minutes. Walking is self-paced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Percentage of hemoglobin A1c	16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Majmaah University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): September 26, 2019
• Study Completion (Actual): September 28, 2019

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Mobility Limitation
• Other Study ID Numbers: MajmaahUNI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The complete data set will be send upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No