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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06450847
Other study ID # USharjah1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date October 2024

Study information

Verified date May 2024
Source University of Sharjah
Contact Amenah Abdelazim, BPT
Phone +971554590707
Email aabdelazim@sharjah.ac.ae
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. This will be a pre-post intervention study with participants divided into three groups: Lean normal metabolic profile, metabolically healthy overweight/obese, and patients with Type 2 Diabetes Mellitus. Assessment of anthropometry and body composition, Soleus Muscle Endurance, blood tests for Inflammatory Markers, Oxidative Stress Markers, and Adipocytokines will be conducted pre and post-intervention.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Residents of UAE, both males and females - Ages 20-50 years - Uncomplicated Type 2 Diabetic on meds, - Normal lean BMI - Overweight and Obese Exclusion Criteria: - Recent orthopedic surgery in the LLs - Pain in the LLs starting from Hips to Ankle. - Presence of Varicose Veins in the LLs - Present History of any cardiovascular condition - Pregnant females - Morbid Obesity - Diabetics undergoing Insulin therapy only - Smokers and alcohol consumption

Study Design


Intervention

Other:
Soleus Muscle Push Up Exercise
Members will be asked to do the SPUs for 270 minutes/day for most days of the week (minimum 5 days) for 3 months: Begin seated on a bench or chair so knees form a 90-degree angle with feet flat on the floor and toes pointed forward. Keep spine straight and shoulders back (not hunched or rounded forward). Using a slow and controlled tempo, push toes into the floor and lift heels off the ground. Hold for one to two seconds, pushing down on the balls of feet. Keep your thigh muscles relaxed. Slowly lower heels and return to start. That's 1 rep. Without shoes Educational session will be given before the intervention time WhatsApp messages will be sent 1-2 times/day to remind the participants to continue doing the exercise and ascertain compliance. Also, the participants are required to daily fill logbook about the duration (in minutes) of the SPU that they did.
Other Exercise
Participants will be asked to continue their regular lifestyle

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sharjah

Outcome

Type Measure Description Time frame Safety issue
Other BMI kg/m2 3 months
Other Anthropometric data including weight, height and fat percentage Measured in kgs, cms and % respectively 3 months
Other Physical Activity and Food habits Questionnaire (International Physical Activity Questionnaire and Food Frequency Questionnaire) 3 months
Other Venous blood specimens Measured in mL, using blood test by specialized personnel 3 months
Primary Adipocytokine levels in the blood Measured in µg/ml, using blood test by specialized personnel 3 months
Secondary Soleus Muscle endurance through Heel Raise Test. • Inflammatory and Oxidative Stress markers through blood sample. Measured as a number, in repetitions. Detailed procedure described previously. 3 months
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