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

• Sponsor: Majmaah University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04364685
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Walking, Difficulty; Diabetes Mellitus, Type 2; Hemoglobin; Hb-SC	Other: Walking on soft-sand; Other: Walking on Levelled Surface	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study consists of two groups, one control group (Normal Walking) and experimental group (sand walking).The study consists of two groups, one control group (Normal Walking) and experimental group (sand walking).
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The investigator responsible for evaluation of patient was blinded to the allocation of the participants.
• Primary Purpose: Treatment
• Official Title: Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial.
• Actual Study Start Date: Jan 25, 2017
• Actual Primary Completion Date: Sep 26, 2019
• Actual Study Completion Date: Sep 28, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. HbA1c [16 weeks]

   Percentage of hemoglobin A1c

Secondary Outcome Measures

1. BMI [16 weeks]

   Body mass index

2. Waist Circumference [2 years]

   the waist circumference was measured by inch tape at the level of Anterior superior iliac spine.

3. Quality of life-39 [16 weeks]

   The Validated quality of life for diabetes containing 39 items and scoring on a 1-7 Likert scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Khalid Hospital	Al Majma'ah	Riyadh	Saudi Arabia	11952

Sponsors and Collaborators

• Majmaah University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: faizan kashoo, PT, Lecturer, Majmaah University
• ClinicalTrials.gov Identifier: NCT04364685
• Other Study ID Numbers: MajmaahUNI
• First Posted: Apr 28, 2020
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Mobility Limitation

Study Results

No Results Posted as of Sep 16, 2020