NCT06450847

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 10, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 22, 2024

Last Update Submit

June 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adipocytokine levels in the blood

    Measured in μg/ml, using blood test by specialized personnel

    3 months

Secondary Outcomes (1)

  • Soleus Muscle endurance through Heel Raise Test. • Inflammatory and Oxidative Stress markers through blood sample.

    3 months

Other Outcomes (4)

  • BMI

    3 months

  • Anthropometric data including weight, height and fat percentage

    3 months

  • Physical Activity and Food habits

    3 months

  • +1 more other outcomes

Study Arms (2)

Interventional group

ACTIVE COMPARATOR
Other: Soleus Muscle Push Up Exercise

Control group

PLACEBO COMPARATOR
Other: Other Exercise

Interventions

Members will be asked to do the SPUs for 270 minutes/day for most days of the week (minimum 5 days) for 3 months: 1. 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). 2. Using a slow and controlled tempo, push toes into the floor and lift heels off the ground. 3. Hold for one to two seconds, pushing down on the balls of feet. Keep your thigh muscles relaxed. 4. 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.

Interventional group

Participants will be asked to continue their regular lifestyle

Control group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Residents of UAE, both males and females
  • Ages 20-50 years
  • Uncomplicated Type 2 Diabetic on meds,
  • Normal lean BMI
  • Overweight and Obese

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityOverweight

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Amenah Abdelazim, BPT

CONTACT

Kalyana Reddy, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 10, 2024

Study Start

June 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

June 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

In case of the need for further expansion of the research, the information might be shared with other researchers in the university without exposure of any personal information or names of participants.