Walking, DifficultyNCT04364685
Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients.
A study testing Walking on soft-sand and Walking on Levelled Surface in people with Walking, Difficulty and Diabetes Mellitus, Type 2, run by Majmaah University at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Walking, Difficulty, Diabetes Mellitus, Type 2, Hemoglobin; Hb-SC
- What is being tested?
- Walking on soft-sand and Walking on Levelled Surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Jan 2017to 28 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 2 Diabetes for past 1 year.
- HbA1c between 7-10%.
- BMI between 25-29.9
- Age Between 45-75
- Sedentary
Who cannot join
- Diabetic Neuropathy
- Active Smoker
- Musculoskeletal conditions
- Cardiovascular conditions
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Khalid Hospital
Al Majma'ah, Riyadh Region, 11952
About this study
Official title: 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.
Read the 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.
- Being tested
- Walking on soft-sand, Walking on Levelled Surface
- Medical subject headings
- Mobility Limitation, Diabetes Mellitus, Type 2, Hemoglobin SC Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking on soft-sandOther
The participants are required to walking on sand for 30 minutes. Walking is self-paced.
Walking on Levelled SurfaceOther
The Participants will be require to walk on the firm surface for 30 minutes. The participants would decide the pace of walking.
| Study group | Role | What they receive |
|---|---|---|
| Normal Walking | Active comparator | The participants performed 30 minutes on levelled surface on the track and field ground. Participants performed moderate intensity walking, self paced. Receives: Other: Walking on Levelled Surface |
| Sand Walking | Experimental | The participants performed supervised walking on sand on the 20 meters pathway containing soft sand.The walking on sand for 30 minutes. Receives: Other: Walking on soft-sand |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Percentage of hemoglobin A1c
Measured: 16 weeks
Secondary outcomes (3)
BMI
Body mass index
Measured: 16 weeks
Waist Circumference
the waist circumference was measured by inch tape at the level of Anterior superior iliac spine.
Measured: 2 years
Quality of life-39
The Validated quality of life for diabetes containing 39 items and scoring on a 1-7 Likert scale.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start25 Jan 2017
- Primary completion26 Sep 2019
- Study completion28 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Walking, DifficultyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two groups, one control group (Normal Walking) and experimental group (sand walking).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, faizan kashoo, PT, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364685
- Sponsor's protocol ID
- MajmaahUNI
- Status last verified
- Sep 2020
- First submitted
- 23 Apr 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The complete data set will be send upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Walking on Sand With Dietary Intervention in Overweight Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04364685
- Acronym / sponsor ID
- MajmaahUNI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of two groups, one control group (Normal Walking) and experimental group (sand walking).
| Arm | Type | Receives |
|---|---|---|
| Normal Walking | Active comparator | Other: Walking on Levelled SurfaceThe participants performed 30 minutes on levelled surface on the track and field ground. Participants performed moderate intensity walking, self paced. |
| Sand Walking | Experimental | Other: Walking on soft-sandThe participants performed supervised walking on sand on the 20 meters pathway containing soft sand.The walking on sand for 30 minutes. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Type 2 Diabetes for past 1 year.
- HbA1c between 7-10%.
- BMI between 25-29.9
- Age Between 45-75
- Sedentary
Key exclusion criteria (4 listed)
- Diabetic Neuropathy
- Active Smoker
- Musculoskeletal conditions
- Cardiovascular conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking on soft-sandThe participants are required to walking on sand for 30 minutes. Walking is self-paced. | Other | Sand Walking |
| Walking on Levelled SurfaceThe Participants will be require to walk on the firm surface for 30 minutes. The participants would decide the pace of walking. | Other | Normal Walking |
Primary outcome
HbA1c
Time frame: 16 weeks
Percentage of hemoglobin A1c
3 secondary outcomes
BMI
Time frame: 16 weeks
Waist Circumference
Time frame: 2 years
Quality of life-39
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided. The complete data set will be send upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking on soft-sand and Walking on Levelled Surface in people with Walking, Difficulty and Diabetes Mellitus, Type 2, run by Majmaah University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.