Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients.
Primary Purpose
Walking, Difficulty, Diabetes Mellitus, Type 2, Hemoglobin; Hb-SC
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Walking on soft-sand
Walking on Levelled Surface
Sponsored by
About this trial
This is an interventional treatment trial for Walking, Difficulty
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Type 2 Diabetes for past 1 year.
- HbA1c between 7-10%.
- BMI between 25-29.9
- Age Between 45-75
- Sedentary
Exclusion Criteria:
- Diabetic Neuropathy
- Active Smoker
- Musculoskeletal conditions
- Cardiovascular conditions
Sites / Locations
- King Khalid Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal Walking
Sand Walking
Arm Description
The participants performed 30 minutes on levelled surface on the track and field ground. Participants performed moderate intensity walking, self paced.
The participants performed supervised walking on sand on the 20 meters pathway containing soft sand.The walking on sand for 30 minutes.
Outcomes
Primary Outcome Measures
HbA1c
Percentage of hemoglobin A1c
Secondary Outcome Measures
BMI
Body mass index
Waist Circumference
the waist circumference was measured by inch tape at the level of Anterior superior iliac spine.
Quality of life-39
The Validated quality of life for diabetes containing 39 items and scoring on a 1-7 Likert scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04364685
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
September 26, 2019 (Actual)
Study Completion Date
September 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Walking, Difficulty, Diabetes Mellitus, Type 2, Hemoglobin; Hb-SC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study consists of two groups, one control group (Normal Walking) and experimental group (sand walking).
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator responsible for evaluation of patient was blinded to the allocation of the participants.
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Walking
Arm Type
Active Comparator
Arm Description
The participants performed 30 minutes on levelled surface on the track and field ground. Participants performed moderate intensity walking, self paced.
Arm Title
Sand Walking
Arm Type
Experimental
Arm Description
The participants performed supervised walking on sand on the 20 meters pathway containing soft sand.The walking on sand for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Walking on soft-sand
Intervention Description
The participants are required to walking on sand for 30 minutes. Walking is self-paced.
Intervention Type
Other
Intervention Name(s)
Walking on Levelled Surface
Intervention Description
The Participants will be require to walk on the firm surface for 30 minutes. The participants would decide the pace of walking.
Primary Outcome Measure Information:
Title
HbA1c
Description
Percentage of hemoglobin A1c
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
BMI
Description
Body mass index
Time Frame
16 weeks
Title
Waist Circumference
Description
the waist circumference was measured by inch tape at the level of Anterior superior iliac spine.
Time Frame
2 years
Title
Quality of life-39
Description
The Validated quality of life for diabetes containing 39 items and scoring on a 1-7 Likert scale.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Type 2 Diabetes for past 1 year.
HbA1c between 7-10%.
BMI between 25-29.9
Age Between 45-75
Sedentary
Exclusion Criteria:
Diabetic Neuropathy
Active Smoker
Musculoskeletal conditions
Cardiovascular conditions
Facility Information:
Facility Name
King Khalid Hospital
City
Al Majma'ah
State/Province
Riyadh
ZIP/Postal Code
11952
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The complete data set will be send upon request.
Learn more about this trial
Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients.
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